A Phase II Multicenter Study of Pomalidomide Monotherapy in HIV-Positive Individuals With Kaposi Sarcoma (KS) in Sub-Saharan Africa (SSA)
Phase: PHASE2
Conditions: Human Immunodeficiency Virus 1 Positive, Skin Kaposi Sarcoma
Sponsor: AIDS Malignancy Consortium

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SUMMARY OF CHANGES 
A Phase II Multicenter Study of Pomalidomide Monotherapy in HIV-Positive Individuals 
with Kaposi Sarcoma (KS) in Sub-Saharan Africa (SSA) 
Version 10.0 
NCI Protocol #: AMC-100 
Local Protocol #: AMC-100 
 
NCI Version Date: 04DEC2023 
Protocol Date: 04DEC2023 
 
I. 
Scientific and Substantive Changes 
# 
Section 
Comments 
1. 
Protocol 
Synopsis 
2.3 
3.3 
Table 12-1 
The accrual targets (overall and by ethnic category), study design and 
rationale, and sample size were updated to reflect the expected 
enrollment of 26 participants instead of the originally planned 30 
participants. 
 
The number of participants to be entered has been reduced from the 
originally planned 30 to 26 because Celgene, the donor of the study 
drug, requires that the last participant begin on study treatment no later 
than December 1, 2023. The revised sample size will provide only a 
slightly reduced statistical power (87.5% vs 90%) to test the null 
hypothesis that the ORR = 10% against the alternative that it is 30% 
with pomalidomide monotherapy at the one-sided 10% significance 
level. 
2. 
10.1.2 
The statistical power calculation was updated to reflect the expected 
enrollment of 26 participants instead of the originally planned 
30 participants. 
3. 
Table 4-1 
10.1.3 
Table 10-1 
Table 10-2 
Due to the expected enrollment of 26 participants instead of the originally 
planned 30 participants, the table describing the criteria for dose reduction, 
the table describing stopping rules for dose-limiting toxicity, and the table 
describing stopping rules for hematologic and non-hematologic toxicity 
were updated to remove the stopping rules for 28-30 participants. In 
addition, the stopping rule for dose-limiting toxicities for 21-27 
participants was adjusted to 21-26, and the stopping rule for hematologic 
and non-hematologic toxicity for 27 participants was removed.  
 

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II. 
Administrative and Editorial Changes 
# 
Section 
Description of Change 
4. 
Protocol 
Roster 
The study statistician was updated from Jeannette Y. Lee, PhD, to 
Deukwoo Kwon, PhD. 
5. 
10.1.1 
The overall response rate meeting the efficacy criteria to merit 
consideration of further clinical development of pomalidomide in this 
clinical setting was converted from 0.3 to 30%. 
6. 
Global 
The version number and date have been updated to version 10.0, dated 
04DEC2023.  

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AIDS MALIGNANCY CONSORTIUM 
 
AMC PROTOCOL #100: 
A Phase II Multicenter Study of Pomalidomide Monotherapy in 
HIV-Positive Individuals with Kaposi Sarcoma (KS) in Sub-
Saharan Africa (SSA) 
A Trial of the AIDS Malignancy Consortium (AMC) 
 
Sponsored by: 
National Cancer Institute 
Office of HIV and AIDS Malignancy (OHAM) 
 
NCT Registration 
Number: 
NCT03601806 
 
Pharmaceutical Support 
Provided by: 
Celgene Corporation 
Pomalidomide (NSC 767909) 
 
Regulatory Status: 
Pursuant to national requirements for each 
participating site 
 
Protocol Chair: 
Susan E. Krown, MD 
 
Protocol Co-Chair: 
Samantha Vogt, MD, MPH 
Version 10.0, 04DEC2023 
NCI Version Date 04DEC2023 

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AMC PROTOCOL SIGNATURE PAGE 
I, ____________________, Principal Investigator at site ________, agree to conduct and follow 
this protocol: AMC Protocol # 100 – A Phase II Multicenter Study of Pomalidomide 
Monotherapy in HIV-Positive Individuals with Kaposi Sarcoma (KS) in Sub-Saharan Africa 
(SSA) (Version 10.0, 04DEC2023), as written according to AMC, NCI, and FDA guidelines. I 
understand that no deviations from the protocol eligibility criteria or waivers for protocol 
deviations will be permitted. 
 
 
_________________________________ 
 
 ______________________ 
Signature 
Date (DDMMMYYYY) 

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TABLE OF CONTENTS 
AMC PROTOCOL SIGNATURE PAGE ......................................................................................... 2 
TABLE OF CONTENTS .................................................................................................................... 3 
LIST OF TABLES ............................................................................................................................... 6 
LIST OF FIGURES ............................................................................................................................. 6 
SITES PARTICIPATING IN THE STUDY ..................................................................................... 7 
PROTOCOL ROSTER ....................................................................................................................... 8 
PROTOCOL SYNOPSIS .................................................................................................................. 10 
PROTOCOL SCHEMA .................................................................................................................... 12 
ABBREVIATIONS LIST .................................................................................................................. 13 
1.0 
OBJECTIVES ........................................................................................................................ 16 
1.1 
Hypotheses .............................................................................................................16 
1.2 
Primary Objective ..................................................................................................16 
1.3 
Secondary Objectives.............................................................................................16 
1.4 
Exploratory Objectives ..........................................................................................16 
2.0 
BACKGROUND .................................................................................................................... 17 
2.1 
Study Disease .........................................................................................................17 
2.2 
Study Agents ..........................................................................................................18 
2.3 
Study Design and Rationale ...................................................................................21 
2.4 
Correlative Studies .................................................................................................22 
3.0 
PARTICIPANT SELECTION ............................................................................................. 24 
3.1 
Eligibility Criteria ..................................................................................................24 
3.2 
Exclusion Criteria ..................................................................................................26 
3.3 
Number of Participants to be Enrolled...................................................................27 
3.4 
Participant Enrollment Procedures ........................................................................27 
4.0 
TREATMENT PLAN ........................................................................................................... 29 
4.1 
Agent Administration.............................................................................................29 
4.2 
Definition of Dose-Limiting Toxicity ....................................................................30 
4.3 
General Concomitant Medication and Supportive Care Guidelines ......................31 
4.4 
Duration of Therapy ...............................................................................................32 
4.5 
Duration of Follow Up ...........................................................................................32 
4.6 
Criteria for Removal from Treatment ....................................................................33 
5.0 
DOSING DELAYS/DOSE MODIFICATIONS .................................................................. 34 

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5.1 
Dose Modifications for Pomalidomide ..................................................................34 
6.0 
ADVERSE EVENTS: LIST AND REPORTING REQUIREMENTS ............................. 39 
6.1 
Comprehensive Adverse Events and Potential Risks list (CAEPR) for 
Pomalidomide (CC-4047, NSC 767909) ...............................................................39 
6.2 
Classification of AEs by Severity and Relationship to Study Drug 
Administration .......................................................................................................42 
6.3 
Expedited Adverse Event Reporting ......................................................................44 
6.4 
Routine Adverse Event Reporting .........................................................................46 
6.5 
Secondary Malignancy...........................................................................................46 
6.6 
Second Malignancy ................................................................................................47 
7.0 
PHARMACEUTICAL INFORMATION ........................................................................... 48 
7.1 
Pomalidomide (NSC # 767909) .............................................................................48 
7.2 
Drug Orders, Transfers, Returns, and Accountability ...........................................50 
8.0 
CLINICAL AND LABORATORY EVALUATIONS ....................................................... 51 
8.1 
Screening Evaluations ............................................................................................51 
8.2 
Baseline Evaluations ..............................................................................................52 
8.3 
Evaluations During Treatment ...............................................................................52 
8.4 
Treatment Discontinuation Evaluations .................................................................53 
8.5 
Follow-up Evaluations ...........................................................................................54 
9.0 
MEASUREMENT OF EFFECT .......................................................................................... 56 
9.1 
Definition of Response ..........................................................................................56 
10.0 
STATISTICAL CONSIDERATIONS ................................................................................. 59 
10.1 
Study Design/Endpoints.........................................................................................59 
11.0 
ROLE OF DATA MANAGEMENT .................................................................................... 63 
11.1 
CRF Instructions ....................................................................................................63 
11.2 
Data Quality ...........................................................................................................63 
11.3 
Data Monitoring .....................................................................................................63 
12.0 
ETHICAL AND REGULATORY CONSIDERATIONS .................................................. 64 
12.1 
IRB Approval and Informed Consent ....................................................................64 
12.2 
Pomalidomide Counseling Program ......................................................................64 
12.3 
Changes to the Protocol .........................................................................................65 
12.4 
Women and Minorities ..........................................................................................65 
13.0 
REFERENCES ...................................................................................................................... 66 

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APPENDIX I: SCHEDULE OF EVALUATIONS ......................................................................... 69 
APPENDIX II: PERFORMANCE STATUS SCALES .................................................................. 72 
APPENDIX III: AMC DATA AND SAFETY MONITORING PLAN ........................................ 73 
APPENDIX IV: PARTICIPANT MEDICATION DIARY ........................................................... 79 
APPENDIX V: CENTRAL PATHOLOGY REVIEW ................................................................... 82 
APPENDIX VI: LIST OF PROHIBITED AND CAUTIONARY MEDICATIONS ................... 83 
APPENDIX VII: POMALIDOMIDE RISKS OF FETAL EXPOSURE, PREGNANCY 
TESTING GUIDELINES AND ACCEPTABLE BIRTH CONTROL METHODS ....... 84 
APPENDIX VIII: POMALIDOMIDE EDUCATION AND COUNSELING GUIDANCE 
DOCUMENT FOR FEMALE PARTICIPANTS ............................................................... 89 
APPENDIX IX: POMALIDOMIDE EDUCATION AND COUNSELING GUIDANCE 
DOCUMENT FOR MALE PARTICIPANTS .................................................................... 92 
APPENDIX X: POMALIDOMIDE INFORMATION SHEET FOR PATIENTS ENROLLED IN 
CLINICAL RESEARCH STUDIES .................................................................................... 94 
APPENDIX XI: POMALIDOMIDE COUNSELING PROGRAM SITE COUNSELOR 
IDENTIFICATION FORM .................................................................................................. 96 
APPENDIX XII: COLLECTION AND SHIPPING INSTRUCTIONS FOR PERIPHERAL 
BLOOD FOR IMMUNE RESPONSE (CYTOKINES AND SOLUBLE RECEPTORS)
 ................................................................................................................................................. 97 
APPENDIX XIII: KS STAGING CRITERIA ................................................................................ 99 
APPENDIX XIV: AIDS Malignancy Consortium (AMC) Data Sharing Plan .......................... 100 
 
 

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LIST OF TABLES 
 
Table 4-1. Criteria for Dose Reduction ..................................................................................... 30 
Table 5-1. Pomalidomide Dose Reduction Steps ...................................................................... 34 
Table 5-2. Dose Modifications For Non-Hematologic Toxicity .............................................. 34 
Table 6-1: Attribution................................................................................................................. 43 
Table 10-1. Stopping Rules for Dose-limiting Toxicity............................................................ 59 
Table 10-2. Stopping Rules for Hematologic and Non-Hematologic Toxicity ...................... 61 
Table 12-1. Accrual Targets ....................................................................................................... 65 
 
LIST OF FIGURES 
Figure 2-1: 
Average Plasma Concentration Profiles by Dose (4mg versus 5mg) and Visit 
(Single-Dose PK versus Multiple-Dose PK) ...................................................... 21 
Figure 5-1: 
Dose modification for and management of neutropenia with/without G-CSF.
............................................................................................................................... 38 
 
 
 

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SITES PARTICIPATING IN THE STUDY 
This protocol will be open for participant enrollment at the AMC core sites in Africa named in the 
protocol roster, as approved by the AMC Executive Committee and the protocol leadership for 
participation. 

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PROTOCOL ROSTER 
AMC Protocol # 100 
A Phase II Multicenter Study of Pomalidomide Monotherapy in HIV-Positive Individuals 
with Kaposi Sarcoma (KS) in Sub-Saharan Africa (SSA) 
 
Protocol Chair: 
Susan E. Krown, MD 
AIDS Malignancy Consortium 
P.O. Box 1051 
Planetarium Station 
127 West 83rd Street 
New York, NY 10024 
Email: krowns@mskcc.org 
Protocol Statistician: 
Deukwoo Kwon, PhD 
Icahn School of Medicine at Mount Sinai 
1425 Madison Avenue, 2nd Floor, Room L2-
70D2 
New York, NY 10029 
Tel: 713-500-7964 
Email: deukwoo.kwon@mountsinai.org 
Protocol Co-Chair: 
Samantha Vogt, MD, MPH 
Johns Hopkins University 
Sidney Kimmel Comprehensive Cancer 
Center 
1650 Orleans Street, CRB1, Room 384 
Baltimore, MD 21287 
Tel: 410-283-2057 
Email: svogt2@jhmi.edu 
Data Management/Operations: 
AMC Operations and Data Management 
Center 
The Emmes Company, LLC. 
401 N. Washington Street, Suite 700 
Rockville, MD 20850 
Tel: 301-251-1161 
Fax: 240-238-2842 
Email: amc-100@emmes.com 
 
 

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Participating Centers: 
Naftali Busakhala, MBChB, MMed 
Moi University School of Medicine, 
Department of Hematology and Oncology 
P.O. BOX 4606 
Eldoret 30100, Kenya 
Tel: +254 722496933 
Email: nbusakhala@yahoo.com 
 
 
Margaret Borok, MBChB 
College of Health Sciences 
Dept. of Medicine Parirenyatwa Hospital 
Mazowe Street 
Harare 
Zimbabwe 
Tel: 263-4-791631 x2272 
Fax: 263-4-705986 
Email: mborok@mweb.co.zw 
Lameck Chinula, MD, MMed 
UNC Project Malawi 
Tidziwe Centre 
100 Mzimba Road, 
Kamuzu Central Hospital 
Private bag A-104 
Lilongwe 
Malawi 
Tel: 265-26-517-50610 
Fax: 265-26-517-55954 
Email: lameck_chinula@med.unc.edu 
Jackson Orem, MBChB 
Uganda Cancer Institute 
P.O. Box 3935 
Kampala, Uganda 
Tel: +256 414 540605/680467 
Fax: +256 414 540410 
Email: jacksonorem@yahoo.co.uk 
 
 

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PROTOCOL SYNOPSIS 
Title: 
A Phase II Multicenter Study of Pomalidomide Monotherapy in 
HIV-Positive Individuals with Kaposi Sarcoma (KS) in Sub-
Saharan Africa (SSA) 
Phase of Study: 
Phase II 
Participating Institutions: 
This protocol will be open to all AMC international member sites 
in sub-Saharan Africa. Participating institutions will also be 
required to complete Celgene’s pregnancy prevention counseling 
training before activating this trial. 
Accrual Target: 
26 participants 
Population: 
Participants with KS and HIV infection. See Section 3.0 for 
eligibility criteria. 
Regimen: 
Each cycle of treatment includes administration of 21 doses of 
pomalidomide during a 4-week period, administered on Days 1-
21 of a 28-day cycle. 
Eligible participants will begin pomalidomide therapy at Dose 
Level 1, 4 mg/day on Days 1-21 of each 28-day cycle. 
Dose level -1, 3 mg/day on Days 1-21 of each 28-day cycle, is 
provided for participants entered on Dose Level 1 who require 
dose reduction. 
Safety and the need for dose reduction will be continuously 
monitored by the protocol team. 
Antitumor effects will be assessed immediately prior to the start 
of each 28-day treatment cycle in all participants and every 12 
weeks after completion of pomalidomide therapy in participants 
showing complete or partial response. 
Duration: 
The maximum duration of treatment is 12, 4-week cycles. 
Primary Objective: 
To determine if pomalidomide monotherapy induces a minimal 
level of antitumor efficacy to justify its further development for 
HIV-associated KS in sub-Saharan Africa and is safe and 
tolerable. 
Secondary Objectives: 
To evaluate the effects of pomalidomide monotherapy on 
standard measures of HIV control, i.e., CD4 counts and HIV viral 
loads, in this participant population. 

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Exploratory Objectives: 
1. To assess the effect of pomalidomide treatment on serum 
cytokine levels. 
2. To evaluate if changes in serum cytokine levels correlate with 
clinical response. 

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PROTOCOL SCHEMA 
 
Screening/ 
Baseline
•Obtain informed consent
•Baseline evaluations within 21 days before study enrollment, unless noted
•Tissue for pathology review (submit FFPE biopsy or slides for LANA staining, 
or images of stains performed by institution)
Cycle 1, Day 1
•Study enrollment
•Complete pregnancy prevention counseling
•Collect 1 red top tube (7mL) for cytokine studies
•Dispense pomalidomide and study diary
Cycles 2-6,
Day 1
•Complete required evaluations within 3 days before next cycle
•If KS tumor assessment shows PD, or participant has DLT or reason for 
protocol discontinuation, discontinue treatment
•Continue treatment if participant has CR, PR, or SD AND has no DLT
•HIV viral load and CD4 before cycles 2 and 4
•1 red top tube before dosing on day 1 of cycle 3 
• Drug adherence assessment, pregnancy testing/counseling, dispense drug
After Cycle 6
•Proceed to cycles 7-12 If participant has CR or PR
•Discontinue treatment if response is SD or PD
Cycles 7-12,
Day 1
•Complete required evaluations within 3 days before next cycle
•If KS tumor assessment shows PD or participant has AE that meets DLT 
definition or reason for protocol discontinuation, discontinue treatment
•Continue treatment if participant has CR or PR AND has no DLT
• HIV viral load and CD4 before cycles 7 and 10
•1 red top tube before dosing on day 1 of cycle 7 
• Drug adherence assessment, pregnancy testing/counseling, dispense drug
Treatment 
Discontinuation
• Complete evaluations within 1 week and repeat at 30 days (±1 week) after 
stopping drug
• HIV viral load and CD4 within 1 week of treatment discontinuation
• If stopping due to SD after cycle 6 or PD, follow-up complete at day 30
•1 red top tube within 1 week of last dose of protocol treatment 
Follow-up 
Evaluations
•Participants that discontinue treatment with CR or PR will have evaluations 
every 12 weeks until 48 weeks after treatment discontinuation (defined as 
day 28 of last cycle), unless PD requiring additional treatment occurs earlier

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ABBREVIATIONS LIST 
Abbreviation 
Definition 
ABV 
doxorubicin, bleomycin, and vincristine 
ACTG 
AIDS Clinical Trials Group 
AE 
adverse event 
AERS 
Adverse Event Reporting System 
AIDS 
acquired immunodeficiency syndrome 
ALT 
alanine aminotransferase 
AMC 
AIDS Malignancy Consortium 
AML 
acute myelocytic leukemia  
ANC 
absolute neutrophil count 
ART 
antiretroviral therapy 
AST 
aspartate aminotransferase 
AZT 
zidovudine 
bFGF 
basic fibroblast growth factor 
b-HCG 
beta human chorionic gonadotropin 
BV 
bleomycin and vincristine 
CAEPR 
Comprehensive Adverse Events and Potential Risks List 
cART 
combined antiretroviral therapy 
CBC 
complete blood count 
CDC 
Centers for Disease Control and Prevention 
CDUS 
Clinical Data Update System 
CR 
complete response 
CRBN 
cereblon 
CRF 
case report form 
CRP 
C-reactive protein 
CT 
computed tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
CTEP 
Cancer Therapy Evaluation Program 
CTMS 
Clinical Trials Monitoring Service 
CXR 
chest X-ray 

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DARF 
Drug Accountability Record Form 
DHHS 
Department of Health and Human Services 
DLT 
dose-limiting toxicity 
E/CIA 
enzyme or chemiluminescence immunoassay 
ECOG 
Eastern Cooperative Oncology Group 
FCBP 
female of child bearing potential 
FDA 
Food and Drug Administration 
GEE 
general estimating equations 
HDPE 
high-density polyethylene 
HHV-8 
human herpesvirus-8 
HIV 
human immunodeficiency virus 
IDB 
Investigational Drug Branch 
IDE 
investigational device exemption 
IEC 
institutional ethics committee 
IME 
important medical event 
IMiD 
immunomodulatory imide drugs 
IND 
investigational new drug 
IRB 
institutional review board 
IUD 
intrauterine device 
KPS 
Karnofsky performance status 
KS 
Kaposi’s sarcoma 
KSHV 
Kaposi’s sarcoma-associated herpesvirus 
LANA 
latency-associated nuclear antigen 
MCD 
multicentric Castleman disease 
MDS 
myelodysplastic syndrome 
MOP 
manual of procedures 
NCI 
National Cancer Institute 
ODMC 
Operations and Data Management Center 
OHAM 
Office of HIV and AIDS Malignancy 
ORR 
Overall response rate 
PCR 
polymerase chain reaction 

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PD 
progressive disease 
P-gp 
P-glycoprotein 
PFS 
progression-free survival 
PI 
principal investigator 
PIO 
Protocol Information Office 
PR 
partial response 
REMS 
Risk Evaluation and Mitigation Strategy 
RNA 
ribonucleic acid 
SAE 
serious adverse event 
SD 
stable disease 
SGOT 
serum glutamic oxaloacetic transaminase 
SGPT 
serum glutamic pyruvic transaminase 
SOC 
system organ class 
SPEER 
Specific Protocol Exceptions to Expedited Reporting 
SSA 
Sub-Saharan Africa 
Th 
T-helper [cell] 
ULN 
upper limit of normal 
VEGF 
vascular endothelial growth factor 
VTE 
venous thromboembolism 
WHO 
World Health Organization 
ZDV 
zidovudine 

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1.0 
OBJECTIVES 
1.1 
Hypotheses 
1.1.1 Pomalidomide will induce an overall response rate of at least 30% in HIV-positive 
individuals with Kaposi sarcoma in sub-Saharan Africa. 
1.1.2 Pomalidomide will be safe and well tolerated at the dose(s) tested in individuals 
with Kaposi sarcoma in sub-Saharan Africa. 
1.1.3 Pomalidomide will not adversely affect CD4 counts and HIV control in HIV-
positive individuals with Kaposi sarcoma in sub-Saharan Africa. 
1.2 
Primary Objective 
To determine if pomalidomide monotherapy induces a minimal level of antitumor efficacy 
to justify its further development for HIV-associated KS in sub-Saharan Africa and is safe 
and tolerable. 
1.3 
Secondary Objectives 
To evaluate the effects of pomalidomide monotherapy on standard measures of HIV 
control, i.e., CD4 counts and HIV viral loads, in this participant population. 
1.4 
Exploratory Objectives 
1.4.1 To assess the effect of pomalidomide treatment on serum cytokine levels. 
1.4.2 To evaluate if changes in serum cytokine levels correlate with clinical response. 

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2.0 
BACKGROUND 
2.1 
Study Disease 
2.1.1 Kaposi sarcoma in sub-Saharan Africa and clinical presentation 
Kaposi sarcoma (KS) is a vascular tumor caused by Kaposi’s sarcoma-associated 
herpesvirus (KSHV) or human herpesvirus-8 (HHV-8). Historically, it has been 
classified into four major types: classic KS, occurring most often in elderly males 
of Mediterranean or Ashkenazi Jewish heritage; endemic KS, occurring in both 
male and female adults and children in Africa; epidemic KS, occurring in 
individuals co-infected with HIV; and, iatrogenic KS, occurring mostly in solid 
organ allograft recipients undergoing immunosuppressive therapy to prevent graft 
rejection. 
In sub-Saharan Africa (SSA), it is estimated that between 35-80% of HIV-infected 
individuals are co-infected with HHV-8 (Campbell 2009, Nguyen 2010, Maskew 
2011). 
This 
high 
co-infection 
rate 
in 
the 
setting 
of 
HIV-induced 
immunosuppression helps to explain why KS is the most common malignancy 
associated with HIV infection in the region and a cause of significant morbidity and 
mortality. 
The clinical manifestations of KS range from the classic pigmented cutaneous 
lesions that can be associated with bleeding and ulceration, to lymphadenopathy, 
oral mucosal lesions, visceral involvement, and lymphedema. Tumor-associated 
edema, which can be a particularly devastating clinical presentation, was reported 
in roughly a third of cases in a cohort of patients in Uganda (Phipps 2010). 
A basic understanding of the mechanism by which KSHV promotes angiogenesis 
and edema can help shed light on possible targets for treatment strategies. KSHV 
is a double-stranded DNA virus that results in either latent or lytic infection of host 
cells. In KS, latent infection of host cells dominates the clinical picture, with only 
5% of cells undergoing lytic replication (Stakus 1997). The differential viral gene 
expression in both the latent and lytic replication states are responsible for the up-
regulation of various inflammatory cytokines including TNF-α, IL-1β, PDGF-B, 
and IL-6 (Naranatt 2004) that can induce production of vascular endothelial growth 
factor (VEGF) and basic fibroblast growth factor (bFGF). VEGF and bFGF have 
subsequently been shown to promote angiogenesis and edema in animal models 
(Samaniego 1998). 
2.1.2 Current treatment strategies in sub-Saharan Africa 
With the advent of widespread availability of combination antiretroviral therapy in 
Africa, there has been a decline in incident cases of KS (Semeere 2012, Bohlius 
2014, Mutyaba 2015), which is an encouraging finding that helps explain why ART 
remains the backbone of therapy for KS. However, ART has proven to be 
insufficient by itself to prevent KS progression and development of new incident 
cases (Rohner 2014, Bower 2014). Furthermore, a diagnosis of KS in HIV-infected 
individuals starting ART in Uganda was associated with a marked increase in 
mortality as compared to those without KS (Asiimwe 2013) and KS was the leading 
cause of early death after initiation of ART in SSA (Lawn 2008, Zachariah 2006, 

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Castelnuovo 2009). 
Current treatment strategies for KS have often been based on an individual’s stage 
at presentation. Patients with Stage T0 disease (KS limited to the skin and lymph 
nodes with no more than minimal oral disease) are often managed with ART alone, 
while patients with Stage T1 disease (KS with tumor-associated edema or 
ulceration, extensive oral disease, and/or visceral disease) are usually considered to 
require systemic chemotherapy in addition to ART. Among patients with T0 
disease, it is not known whether some patients may also benefit from the early 
addition of chemotherapy to ART. 
In SSA, several chemotherapy options have been used including the ABV regimen 
(doxorubicin, bleomycin and vincristine) (Bihl 2007), BV (bleomycin and 
vincristine) or single agent paclitaxel (Herce 2015), and gemcitabine (Strother 
2010). However, there is limited data from prospective randomized clinical trials 
in Africa and no overall survival benefit was seen in the trial conducted by Mosam 
et al. comparing mostly patients with T1 disease receiving either ART alone or 
ART plus chemotherapy (ABV or, in some cases, oral etoposide) (Mosam 2012), 
suggesting that further research is desperately needed to help establish the standard 
of care for patients with KS in SSA. Currently, large randomized trials are in 
progress to evaluate optimal treatment strategies for management of both limited-
stage 
and 
advanced 
KS 
in 
resource-limited 
settings 
(NCT01352117, 
NCT01435018), including SSA, but the results of these studies, which utilize ART, 
either alone or combined with different chemotherapeutic regimens, will not be 
available for several years. 
2.1.3 Rationale for treatment of KS with IMiDs 
In recent years, a class of medications called IMiDs (immunomodulatory imide 
drugs) has gained traction in the management of several malignancies, including 
KS, based on their anti-inflammatory, anti-angiogenic, and immunomodulatory 
properties. Case reports describing improvement in KS lesions and HHV-8 viral 
titers in KS patients treated with thalidomide (Soler 1996, Carlesimo 1995), set the 
stage for further research into this class of medications in KS treatment. 
Additionally, their oral bioavailability and limited side effect profile, particularly 
with the next generation IMiD, pomalidomide, are important factors supporting 
their attractiveness for KS treatment in resource-limited settings, including SSA. 
Two Phase II trials of thalidomide (Little 2000, Fife 1998) reported partial response 
rates in AIDS-related KS ranging from 35-47%. Case reports have also described 
responses of advanced KS to lenalidomide (Martinez 2011, Steff 2013), a second-
generation IMiD notable for its increased activity (compared to thalidomide) 
against TNF-α and IL-6 (Chaulet 2011). Lenalidomide was recently evaluated by 
the AIDS Malignancy Consortium (AMC) in a Phase I/II clinical trial in AIDS-
associated KS (NCT01057121). Preliminary results indicate a response rate in 
excess of 40% (K. Shimabukuro, E. Reid, unpublished results). 
2.2 
Study Agents 
2.2.1 Pomalidomide 

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Pomalidomide, a next generation IMiD, was designed to further increase the anti-
angiogenic and immunomodulatory effects compared to the prior IMiD 
compounds. Pomalidomide promotes T helper cell (Th)-1differentiation in vitro 
(Xu 2008) and increased Th-1 cytokine production in animal models (Dredge 
2002). In pre-clinical studies, pomalidomide was shown to be effective against 
myeloma and B-cell lymphoma cell lines (Lentzsch 2002) and have significant anti-
angiogenic properties (Dredge 2002). It was initially postulated that the anti-
angiogenic mechanism of action for both the parent compound thalidomide, and 
the subsequent IMiD derivatives was closely linked to their teratogenic potential. 
With the discovery of cereblon (CRBN) as the primary target of thalidomide 
teratogenicity (Ito 2010), the interaction between pomalidomide and CRBN has 
been further investigated. Not only does pomalidomide bind CRBN in vitro, but 
resistance to pomalidomide in myeloma cell lines is associated with a decrease in 
CRBN protein expression (Lopez-Girona 2012, Zhu 2011). Upon binding to 
CRBN, the IMiD-CRBN complex results in ubiquination and proteasome-
dependent degradation of the transcription factors Ikaros and Ailos, which in turn 
are responsible for the downregulation of c-Myc and IRF4 (Gandhi 2014, Kronke 
2014, Licht 2014, Lu 2010, Zhu 2014). These in vitro findings highlight the 
importance of the interaction of pomalidomide with CRBN, but the dynamics of 
this interaction and mechanism of resistance with clinical correlation require further 
investigation. 
Clinically, in a phase 1 study evaluating pomalidomide treatment in 24 patients 
with relapsed or refractory multiple myeloma, pomalidomide was overall well 
tolerated, although three patients developed DVTs in the months following 
treatment (Schey 2004). Six patients developed Grade 4 neutropenia and eight 
patients developed Grade 3; Grade 4 thrombocytopenia was seen in three patients. 
After promising results in several Phase II trials (Usmani 2014, Richardson 2014), 
a Phase III trial of pomalidomide combined with dexamethasone compared to 
dexamethasone alone in relapsed or refractory multiple myeloma showed an 
improved progression-free survival (PFS) of 4.0 months versus 1.9 months with a 
median follow-up of 10 months (San Miguel 2013). Taken together the results of 
various clinical trials ultimately led to Food and Drug Administration (FDA) 
approval of pomalidomide for relapsed or refractory multiple myeloma in February 
2013. 
Pomalidomide was evaluated in a phase I/II clinical trial (NCT01495598) for the 
treatment KS at the U.S. National Cancer Institute (NCI). Published results from 
the first 22 patients (15 HIV-infected and 7 HIV-uninfected) showed a 5 mg dose 
given daily for 21 days per 28-day cycle to be well tolerated (Polizzotto 2016). 16 
patients (73%) had an objective response, including four patients showing complete 
response (CR) (18%) and 12 patients showing partial response (PR) (55%). An 
additional three patients showed stable disease (SD) (14%). Grade 3 or 4 adverse 
events included neutropenia (12 patients), infection (1 patient), and peripheral 
edema (1 patient), while other side effects such as cytopenias, constipation, rash, 
and fatigue were reported as mild. 
Duration of treatment ranged from 2-12 months of therapy, with two patients 

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currently remaining on pomalidomide. Reasons for variation in duration of 
treatment included patient and principal investigator (PI) discretion (i.e., need for 
surgery and bone pain from granulocyte-colony stimulating factor (GCSF)), and 
completion of planned number of cycles. While these results are encouraging there 
are several limitations including an inability to evaluate duration of unmaintained 
remission. Additionally, in at least three cases, progression occurred in the setting 
of a confounding factor (1 case occurred in a patient who developed KSHV-
Multicentric Castleman Disease (MCD) after the patient received rituximab, a 
known iatrogenic cause of KS progression; one case occurred in the setting of 
cellulitis and KSHV-associated Inflammatory Cytokine Syndrome; one case 
occurred during a lapse in ART therapy). 
A particularly interesting observation in this trial was the documented clinical 
improvement in tumor-associated limb edema with pomalidomide treatment (Mark 
Polizzotto, personal communication). Of 15 participants noted to have edema at the 
start of treatment, eight showed a decrease in limb circumference measurements of 
at least two centimeters (cm) with therapy and an additional two patients reported 
subjective improvement in limb edema (1 patient reported decreased pedal pain; 
one patient reported an ability to wear closed toe shoes again). Based on the data 
from this study, which eventually included 28 participants (18 HIV-postive and 10 
HIV-negative), on May 14, 2020 the U.S. Food and Drug Administration expanded 
the indication of pomalidomide to include treating adult patients with AIDS-related 
KS after failure of highly active antiretroviral therapy and KS in adult patients who 
are HIV-negative. 
Individuals with HIV-associated KS in Africa often have a spectrum of co-
morbidities (e.g., anemia, infections, and nutritional deficiencies) that differ from 
those of HIV-infected individuals in the U.S., and which may affect drug tolerance. 
Thus, it will be important to determine whether the same dose and schedule of 
pomalidomide tolerated in a study of KS patients in the U.S. will be equally well 
tolerated in SSA. Additionally, further PK analysis of pomalidomide dosing 
performed by Celgene (Fig. 2-1) suggests overlapped exposures for 4 mg and 5 mg 
doses, indicating that there is no clinically meaningful exposure differentiation 
between the 4 mg and 5 mg dose. For this reason, and because a 4 mg dose (but not 
a 5 mg dose) is commercially available, we will conduct this trial using the 4 mg 
starting dose. 

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Figure 2-1: Average Plasma Concentration Profiles by Dose (4mg versus 5mg) 
and Visit (Single-Dose PK versus Multiple-Dose PK) 
 
 
Teratogenicity with the IMiD compounds has long been a concern since the early 
experience with thalidomide in the late 1950s and early 1960s and the subsequent 
development of birth defects. Upon approving pomalidomide, the FDA noted its 
teratogenic potential in both rats and rabbits when administered during 
organogenesis, garnering it Category X designation in pregnancy. This has required 
special precautions among both men and women receiving pomalidomide, and the 
requirement for enrollment in a Risk Evaluation and Mitigation Strategy (REMS) 
program to avoid embryo-fetal exposure. Mitigating these risks will be particularly 
important in AIDS-KS patients in SSA, where most affected individuals are 
heterosexual and a significant proportion are women of childbearing potential. 
2.3 
Study Design and Rationale 
This is an open label, Phase II study of orally administered pomalidomide in participants 
with AIDS-associated KS in sub-Saharan Africa. 
Pomalidomide monotherapy will be evaluated in 26 participants, who will be enrolled at a 
daily oral dose of 4 mg daily for 21 days of a 28-day cycle. This dosage may be de-escalated 
to 3 mg daily for 21 days of a 28-day cycle if ≥ Grade 2 toxicities are observed. 

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Pomalidomide will be considered for future development in this setting, either as a single 
agent or in combination with other anti-KS therapy, if the following conditions are met: 
• An overall response rate of at least 30% is achieved; and, 
• Either of the doses tested are tolerable, defined as no more than six participants showing 
≥ Grade 3 toxicities. 
2.4 
Correlative Studies 
Pomalidomide 
was 
designed 
to 
further 
increase 
the 
anti-angiogenic 
and 
immunomodulatory effects compared to the prior IMiD compounds. Pomalidomide 
promotes Th-1 differentiation in vitro (Xu 2008) and increased Th-1 cytokine production 
in animal models (Dredge 2002). Pomalidomide is known to be a potent 
immunomodulatory agent; pomalidomide and other IMiDs have anti-inflammatory, anti-
angiogenic, and immunomodulatory properties. In patients with multiple myeloma, 
pomalidomide is known to decrease the production of inflammatory cytokines (IL1 and 
IL6), as well as VEGF, an angiogenesis-promoting factor, and to enhance immune 
responses, with increased T cell activity, decreased Treg activity and enhanced IFNγ 
production (Chanan-Khan 2013). Thalidomide and thalidomide-like drugs also are known 
to inhibit the production of pro-inflammatory cytokines, including TNFα, and in addition, 
can enhance T cell immunity (Corral 2008). 
Since the pathogenesis of Kaposi’s sarcoma (KS) is believed to involved the up-regulation 
of various inflammatory cytokines, including TNFα, IL1β, and IL6 (Naranatt 2004), which 
promote inflammation and induce production factors that promote angiogenesis (PDGF, 
VEGF), in the setting of deficient T cell immune responsiveness, it is important to better 
define the effects of pomalidomide therapy on serum levels of these pro-inflammatory and 
immunomodulatory molecules. 
For this reason, the following cytokines will be measured at baseline, after cycles 2 and 6, 
and at treatment discontinuation: CRP and sTNFR2 as markers of systemic inflammation, 
VEGF as a marker of angiogenesis, IP10 (an IFN-inducible inflammation-associated 
chemokine), IL8, TNFα, IL17A/E, IL6 and IL10 (inflammation-associated cytokines), 
sCD27, IFNγ and sIL2Rα (immune activation biomarkers), and sCD14 and sCD163 
(macrophage activation/inflammation-associated molecules). Multiple cytokines will be 
measured, as serum levels of these potent immunomodulatory molecules are near the limit 
of detection of conventional immunometric assays, even in persons who have 
inflammatory conditions. Therefore, measurement of several cytokines can provide a more 
complete picture of the inflammatory milieu in patients. Since these will be measured using 
Luminex multiplexed assays (Luminex, Austin, Texas, USA), a fluorescent bead-based 
assay which quantifies levels of several molecules simultaneously in one reaction volume, 
it is possible to do this without increasing the serum volume required, and with minimal 
added expense. 
We hypothesize that pomalidomide will dampen the production of TH17 and inflammatory 
cytokines (decreased levels of IL17, IL6, IP10, IL8, TNF, IL10), resulting in decreased 
levels of inflammation (decreased CRP and sTNFR2), angiogenesis (decreased VEGF), 
and of soluble receptors that result from monocyte/macrophage activation (decreased 
sCD14, sCD163), and that it will enhance immune activation (increased levels of IFNγ, 

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sIL2Rα and sCD27). Additionally, it is expected that these anti-inflammation, anti-
angiogenic and immune-enhancing responses will be associated with clinical responses to 
therapy. 
Assays will be performed at the AMC Protein Biomarker Profiling Core Laboratory (See 
Appendix XII). 

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3.0 
PARTICIPANT SELECTION 
A rostered AMC investigator (CTEP-registered physician investigator) must document that 
each protocol participant meets all stated eligibility criteria. Participating sites must have 
documentation that each eligibility requirement is satisfied prior to participant enrollment. 
In compliance with CTEP policy, no exceptions to eligibility criteria will be granted under 
any circumstance. 
3.1 
Eligibility Criteria 
3.1.1 Participants must have measurable cutaneous KS that has been pathologically 
confirmed by an AMC-approved pathologist. Diagnostic tissue must be available 
to satisfy the tissue submission requirements at Appendix V for central pathology 
review. 
3.1.2 Participants may not show evidence for ongoing improvement in KS lesions in the 
4 weeks prior to enrollment. 
3.1.3 HIV positive. Documentation of HIV-1 infection by means of any one of the 
following: 
• HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating >1000 RNA 
copies/mL confirmed by a licensed screening antibody and/or HIV antibody 
antigen combination assay; 
• Any licensed HIV screening antibody and/or HIV antibody/antigen combination 
assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot 
confirmation or HIV rapid multispot antibody differentiation assay. 
Note: The term “licensed” refers to a kit that has been certified or licensed by an 
oversight body within the participating country and validated internally. 
WHO (World Health Organization) and CDC (Centers for Disease Control and 
Prevention) guidelines mandate that confirmation of the initial test result must use 
a test that is different from the one used for the initial assessment. A reactive initial 
rapid test should be confirmed by either another type of rapid assay or an E/CIA 
that is based on a different antigen preparation and/or different test principle (e.g., 
indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load. 
3.1.4 Age ≥ 18 years. 
Because no dosing or adverse event data are currently available on the use of 
Pomalidomide in participants <18 years of age, children are excluded from this 
study. 
3.1.5 Eastern Cooperative Oncology Group (ECOG) performance status < 2 (Karnofsky 
Performance Status (KPS) > 50, see Appendix II). 
3.1.6 Life expectancy ≥ 12 weeks. 
3.1.7 Participants must have organ and marrow function within the following parameters, 
unsupported by hematopoietic growth factors within 7 days prior to enrollment: 
• Hemoglobin ≥ 8 g/dL 

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• Absolute neutrophil count (ANC): ≥ 1,000 cells/mm3 (1.0 x 109/L) 
• Platelets: ≥ 75,000 cells/mm3 (75.0 x 109/L) 
• Total bilirubin: ≤ 1.5 times the upper limit of normal (ULN), unless the 
participant is receiving an antiretroviral drug known to be associated with 
increased bilirubin, in which case the direct fraction should be ≤ 2 times the 
ULN. 
• Serum AST (SGOT) / ALT (SGPT): ≤ 2.5 x ULN 
• Estimated or measured creatinine clearance ≥ 60 mL/minute (1.00 mL/s) (serum 
creatinine ≤ 2.0 mg/dL / 176.8 µmol/L) 
3.1.8 Currently receiving local standard of care ART for ≥ 12 weeks, with HIV viral load 
≤ 400 copies/mL within the preceding 12 weeks prior to enrollment. 
Participants are required to be on antiretroviral regimens that are in accordance with 
the current International AIDS Society guidelines concurrently with chemotherapy. 
Excepting agents containing zidovudine, which is prohibited, the specific agents 
are at the discretion of the Investigator and the use of investigational ART agents 
currently available on an expanded access basis is allowed. 
3.1.9 A FCBP is a female who has achieved menarche at some point, is < 60 years of 
age, and who meets one of the following criteria: 
1) has not undergone a hysterectomy or bilateral oophorectomy, or 
2) has not been naturally postmenopausal (amenorrhea following cancer therapy 
does not rule out childbearing potential) for at least 24 consecutive months (i.e., has 
had menses at any time in the preceding 24 consecutive months), or 
3) does not have a serum or plasma FSH >40 mIU/mL and a history of amenorrhea 
x ≥ 1 year 
FCBP must have a negative serum or urine pregnancy test with a sensitivity of at 
least 25 mIU/mL within 14 days prior to enrollment and again within 24 hours of 
starting pomalidomide and must either commit to continued abstinence from 
heterosexual intercourse or, if complete abstinence cannot be assured, they must 
begin TWO acceptable methods of birth control, including one of the following 
highly effective, long-acting methods, DepoProvera, an intrauterine device (IUD), 
an implant*, or bilateral tubal ligation, if it can be verified that the procedure was 
performed, and one additional effective method AT THE SAME TIME, at least 28 
days before she starts taking pomalidomide. FCBP must also agree to ongoing 
pregnancy testing. 
* NOTE: Implants containing levonorgestrel and etonogestrel are prohibited in 
women receiving efavirenz, as drug interactions will render the implants 
ineffective. 
Men must agree to use a latex condom during sexual contact with a FCBP even if 
they have had a vasectomy. 
All participants must be counseled at a minimum of every 28 days about pregnancy 

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precautions and risks of fetal exposure. Serum or urine pregnancy testing will be 
repeated in FCBP, and must be negative, within 24 hours of starting each new cycle 
of pomalidomide. See Appendix VII: Pomalidomide Risks of Fetal Exposure, 
Pregnancy Testing Guidelines and Acceptable Birth Control Methods, AND also 
Appendix VIII: Pomalidomide Education and Counseling Guidance Document for 
further instructions. 
3.1.10 Able to take aspirin daily as prophylactic anticoagulation as described in Section 
4.3. 
3.1.11 Ability to understand and the willingness to sign a written informed consent 
document. 
3.2 
Exclusion Criteria 
Participants who do not fulfill the criteria as listed in Section 3.1 above, are ineligible. 
Additionally, the presence of any of the following conditions will exclude a participant 
from study enrollment: 
3.2.1 Participants who are receiving any other investigational agents (except as permitted 
in 3.1.8). 
3.2.2 Any prior use of thalidomide, lenalidomide, or pomalidomide. 
3.2.3 History of allergic reactions attributed to compounds of similar chemical or 
biologic composition to pomalidomide. 
3.2.4 Participants who have visceral disease requiring cytotoxic chemotherapy (i.e., 
pulmonary KS, symptomatic gastrointestinal KS) or in whom the omission of 
conventional cytotoxic chemotherapy is not consistent with the local standard of 
care. KS-related lymphedema is permitted. 
3.2.5 Use of agents containing zidovudine (including Combivir® and Trizivir®) are 
prohibited. In order to be eligible, participants taking zidovudine must change to a 
different regimen at least 7 days prior to therapy initiation. Changes to ART therapy 
during the study may be made if medically necessary (toxicity, failure of regimen, 
etc.). 
Use of medications or substances that are strong inhibitors of CYP1A2, which 
include amiodarone, cimetidine, fluoroquinolones (e.g., ciprofloxacin, enoxacin), 
fluvoxamine, and ticlopidine is prohibited. 
Co-administration of efavirenz, an inhibitor of CYP1A2, with strong inhibitors of 
CYP3A4 and P-glycoprotein (P-gp) is prohibited. See Appendix VI for a list of all 
prohibited medications on this trial. 
Use of erythropoietin is prohibited. 
Co-administration of corticosteroids greater than doses required for treatment of 
adrenal insufficiency is prohibited. 
Because the lists of these agents are constantly changing, it is important to regularly 
consult frequently updated medical references. 
3.2.6 Uncontrolled intercurrent illness including, but not limited to, ongoing or active 

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infection for which the participant has not completed at least 14 days of therapy 
prior to study enrollment and/or is not clinically stable; symptomatic congestive 
heart failure; unstable angina pectoris; cardiac arrhythmia; or psychiatric 
illness/social situations that, in the opinion of the investigator, would limit 
compliance with study requirements. 
3.2.7 Pregnant women are excluded from this study because pomalidomide is a 
thalidomide analog with the potential for teratogenic or abortifacient effects. 
Because there is an unknown but potential risk for adverse events in nursing infants 
secondary to treatment of the mother with pomalidomide, breastfeeding should be 
discontinued if the mother is treated with pomalidomide. 
3.2.8 Specific KS therapy, including cytotoxic chemotherapy but not including ART, 
within the past 4 weeks. 
3.2.9 Use of other anticancer treatments or agents within the past 4 weeks. 
3.2.10 History of malignant tumors other than KS, unless: 
• In complete remission for ≥ 1 year, or 
• Completely resected basal cell carcinoma, or 
• In situ squamous cell carcinoma of the cervix or anus. 
3.2.11 Grade > 1 peripheral neuropathy. 
3.2.12 History of myocardial infarction (MI), cerebrovascular accident, or venous or 
arterial thromboembolism, unless line-related thrombosis without embolus 
occurring greater than 1 year prior to study entry. 
3.2.13 Known procoagulant disorder including prothrombin gene mutation 20210, 
antithrombin III deficiency, protein C deficiency, protein S deficiency and 
antiphospholipid syndrome but not including heterozygosity for the Factor V 
Leiden mutation or the presence of a lupus anticoagulant in the absence of other 
criteria for the antiphospholipid syndrome. 
3.2.14 Any condition, including the presence of current laboratory abnormalities or other 
factor that, in the opinion of the investigator, places the participant at unacceptable 
risk if they were to participate in the study or confounds the ability to interpret data 
from the study. 
3.3 
Number of Participants to be Enrolled 
3.3.1 Proposed sample size 
This study will enroll 26 participants. 
3.3.2 Accrual rate 
Approximately two participants per month. 
3.4 
Participant Enrollment Procedures 
This study will be available for enrollment at the AMC African sites. Sites must have this 
protocol approved by their Institutional Review Boards (IRB), national regulatory 
authority (where required) and be registered with the AMC Operations and Data 

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Management Center (ODMC) before they may enroll participants. Protocol registration 
instructions and forms will be made available on the AMC Operations website 
(www.AIDSCancer.org). Participating sites may not order study drugs until protocol 
registration with the AMC ODMC is complete. 
3.4.1 Registration for Screening 
After an informed consent form has been signed by the participant, the participant 
must be registered for screening (AMC-100 Screening Segment) on-line via the 
AMC Advantage eClinicalSM Internet Data Entry System. After successful 
registration into the screening segment, the participant will receive an eleven-digit 
participant ID and will then enter the screening process. Participants will be 
enrolled on-line via the AMC Internet Data Entry System no more than 42 days 
prior to the initiation of treatment. Once the eligibility checklist is submitted, a 
system-generated confirmation will be sent to the site staff, AMC ODMC, and 
Protocol Chair upon successful registration. 
Please reference the AMC-100 MOP for additional details regarding the required 
tests prior to enrollment in the screening segment. 
If the on-line system is inaccessible for Screening Registration (Screening 
Segment), the site should notify the AMC ODMC via email at amipm@emmes.com 
or via phone at 1-301-251-1161 for further instructions. Please refer to the AMC-
100 MOP for additional instructions. 
3.4.2 Treatment Segment Enrollment 
After all required eligibility assessments are complete, the participating site will 
complete the protocol-specific eligibility checklist and enroll the participant into 
the AMC-100 Treatment Segment on-line via the AMC Advantage eClinical
SM 
Internet Data Entry System. The participating site will ensure the participant meets 
all eligibility criteria prior to completing the protocol-specific eligibility checklist. 
Participants will be enrolled on-line via the AMC Internet Data Entry System no 
more than 1 week prior to the initiation of treatment (enrollment 1 day prior to or 
on the day of treatment is strongly encouraged). Once the eligibility checklist is 
submitted, a system-generated confirmation will be sent to the site staff, AMC 
ODMC, and Protocol Chair upon successful registration. 
If the on-line system is inaccessible for Treatment Enrollment Registration 
(Treatment Segment), the site should notify the AMC ODMC via email at 
amipm@emmes.com or via phone at 301-251-1161 for further instructions. 

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4.0 
TREATMENT PLAN 
4.1 
Agent Administration 
Pomalidomide will be administered on an outpatient basis. Reported adverse events and 
potential risks for pomalidomide are described in Section 6.0. Appropriate dose 
modifications for pomalidomide are described in Section 5.0. No investigational or 
commercial agents or therapies other than those described below may be administered with 
the intent to treat the participant's malignancy. 
NOTES: At all times, when dispensing study drug, research center personnel will 
review the instructions, printed on the packaging, with participants. The participant 
will be requested to maintain a medication diary of each dose of medication 
(Appendix IV). The medication diary will be returned to clinic staff at the end of each 
course. 
The site will be required to document study agent return by participant in source 
documents. Non-compliance with study agent administration should be noted at the 
time of diary collection and the participant should be instructed again regarding 
dosing instructions. 
4.1.1 Pomalidomide 
Each cycle of treatment includes administration of 21 doses of pomalidomide 
during a 4-week period, administered on days 1-21 of a 28-day cycle (± 2 days). 
The maximum duration of treatment is twelve 4-week cycles. Pomalidomide will 
be administered on a daily schedule at approximately the same time each day. At 
each dose administration, the capsule number corresponding to the appropriate dose 
level of pomalidomide is to be swallowed whole with a glass of water (150-200 
mL). Participants should be instructed not to bite or chew on the capsule. In case of 
breakage of the capsule in the oral cavity, an additional glass of water should be 
taken immediately. Participants will be instructed to fill out a medication diary to 
record medication administered each day. 
Study medications will be dispensed at study entry (day 1) and at each subsequent 
study visit at the start of a new cycle. Participants will be instructed to return any 
unused study medication and medication containers at each study visit and bring 
their completed medication diary to each study visit. At each visit, medication 
diaries and returned medication counts will be performed and participants will 
undergo repeat counseling and medication adherence assessments. Participants will 
receive up to six cycles of pomalidomide if they have stable disease, or up to 12 
cycles of pomalidomide if they show a complete or partial tumor response, unless 
they develop unacceptable toxicity or meet another protocol-defined reason for 
treatment discontinuation. 
Only enough pomalidomide for one cycle of treatment will be provided to the 
participant at the start of each cycle. 
If participants miss a dose, the dose may still be taken up to 12 hours after the time 
they normally would take it. If more than 12 hours have elapsed, the dose should be 
skipped. Take the next dose at the usual time. Participants should not take 2 doses to 
make up for the one they missed. Participants who take more than the prescribed 

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dose of pomalidomide should be instructed to contact the study staff immediately 
and to seek emergency medical care if needed. 
4.1.2 Pomalidomide dosage levels 
Eligible participants will begin pomalidomide therapy at dose level 1, 4 mg/day on 
days 1-21 of each 28-day cycle. 
Dose level -1, 3 mg/day on days 1-21 of each 28-day cycle, is provided for 
participants entered on dose level 1 who require dose reduction. 
Safety and the need for dose reduction will be continuously monitored by the 
protocol team. 
The following table shows the number of participants who require dose reduction 
based on first cycle adverse events that are needed for the starting dosage level to 
be reduced to 3 mg/day in subsequent participants. 
Table 4-1. Criteria for Dose Reduction 
No. 
of 
participants 
enrolled 
More than X participants who 
required dosage reduction due 
to first cycle DLTs 
7-8 
2 
9-14 
3 
15-20 
4 
21-26 
5 
This table is based on the probability of observing ≥ x participants who require AE-
related dosage reductions is < 0.05. if the underlying proportion of participants who 
require dosage reductions due to adverse events (AE) is 0.10. 
4.2 
Definition of Dose-Limiting Toxicity 
Dose limiting toxicity (DLT) will be defined as the occurrence of any of the following 
during the first cycle of protocol treatment: 
• Hematologic: Defined as neutropenia (ANC < 500/mm3) or thrombocytopenia 
(platelets < 25,000/mm3) lasting longer than seven days. 
• Non-hematologic: Defined as any Grade 3 pomalidomide-related toxicity lasting seven 
days or longer or Grade 4 toxicity. Nausea, vomiting, and diarrhea are not DLTs if they 
can be managed with standard antiemetic and antidiarrheal medications. Incidental 
laboratory abnormalities that do not reflect underlying organ dysfunction are not DLTs. 
o Any instance of bullous erythema multiforme syndrome, toxic epidermal necrolysis 
syndrome (TENS), or Stevens-Johnson syndrome 
• Failure to complete ≥ 80% of the planned 21 doses (i.e., > 17 doses) of a pomalidomide 
treatment course due to pomalidomide-related toxicities. 
Toxicities will be graded according to the NCI Common Terminology Criteria for Adverse 

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Events (CTCAE) Version 5.0 as outlined in Section 6.0. If multiple toxicities are seen, the 
presence of DLT will be based on the most severe toxicity experiences. 
During the period for evaluating dose-limiting toxicity, participants who withdraw from 
the study or do not complete the required cycles of treatment owing to reasons other than 
drug-related adverse events can be replaced. 
See Section 10.1.2 for early stopping rules based on the frequency of first-cycle DLT. 
4.3 
General Concomitant Medication and Supportive Care Guidelines 
In general, concomitant medications and therapies deemed necessary for the supportive 
care and safety of the participant, including transfusions of blood and blood products, 
antibiotics, and antiemetics when appropriate, are allowed. 
The administration of any other therapies intended to treat KS including chemotherapy and 
biologic agents is NOT permitted. The use of other concurrent investigational drugs is not 
allowed. 
All participants must be on stable antiretroviral therapy (ART) for a minimum of 12 weeks 
prior to study entry with an acceptable regimen that adheres to national guidelines for 
treatment of HIV infection. Participants are not allowed to receive zidovudine (AZT; 
ZDV) as part of the ART regimen, since it is myelosuppressive. Zidovudine may be 
discontinued and substituted as clinically indicated upon enrollment. If zidovudine is 
substituted, it must be at least 7 days prior to therapy initiation (see Section 3.2.5). 
Strong inhibitors of CYP1A2, including: amiodarone, cimetidine, fluoroquinolones (e.g., 
ciprofloxacin, enoxacin), fluvoxamine; and ticlopidine are prohibited. 
Co-administration of efavirenz, an inhibitor of CYP1A2, with strong inhibitors of CYP3A4 
and P-glycoprotein (P-gp) is prohibited. 
Use of erythropoietin is prohibited. 
Because there is a potential for interaction of pomalidomide with other concomitantly 
administered drugs through the cytochrome P450 system, the case report form must capture 
the concurrent use of all other drugs, over-the-counter medications, or alternative therapies. 
The protocol chairs should be alerted if the participant is taking any agent known to affect 
or with the potential to affect selected CYP450 isoenzymes. Appendix VI presents 
guidelines for identifying medications/substances that could potentially interact with the 
study agent. 
Participants MUST receive medically appropriate care and treatment for HIV infection, 
including antiretroviral medications. Due to known cytochrome P450 inhibitory effects of 
protease inhibitors, particularly for ritonavir, the case report form will particularly note the 
use of ritonavir for HIV management. 
Anticoagulation consideration 
Pomalidomide increases the risk of thrombotic events in patients who are at high risk or 
with a history a thrombosis, in particular when combined with other drugs known to cause 
thrombosis. 
Participants must receive aspirin by mouth daily x 28 days for each cycle of pomalidomide 

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and for 30 days after the last pomalidomide dose. The recommended dose is 75-100mg 
daily, unless they are already receiving aspirin at an equal or higher daily dose for another 
indication. If the recommended dose of aspirin is not available, a dose of up to 325 mg 
daily may be administered. 
Steroid considerations 
Concurrent administration of corticosteroids greater than doses required for treatment of 
adrenal insufficiency is prohibited. 
Estrogen-containing compounds 
Concurrent administration of estrogen containing compounds, including estrogen 
containing contraceptives, may increase the risk of thrombosis. These compounds should 
be avoided during pomalidomide treatment. 
Tobacco use 
Concurrent tobacco use during pomalidomide therapy may increase the risk for thrombosis. 
Study staff will obtain information on participants’ tobacco smoking history with 
participants at baseline. Participants who are current smokers will be provided guidance 
for smoking cessation per local policies. 
Management of concurrent infections 
The management of active tuberculosis (TB) or cryptococcal meningitis (CM) for 
participants will be per the local standard of care at the respective sites where the study is 
being carried out. 
4.4 
Duration of Therapy 
Treatment may continue for up to 6 cycles for participants with stable disease, or up to 12 
cycles if they have complete or partial response, or until one of the following criteria 
applies: 
• Disease progression 
• Intercurrent illness that prevents further administration of treatment 
• Unacceptable adverse event(s), as defined in Section 5.1 
• Participant decides to withdraw from the study 
• General or specific changes in the participant's condition render the participant 
unsuitable for further treatment in the judgment of the investigator, including but not 
limited to: 
o Pregnancy 
o Failure to return for scheduled follow up for more than 42 days 
4.5 
Duration of Follow Up 
Participants with complete response (CR) or partial response (PR) will be followed for up 
to 48 weeks after their last dose of study treatment or until PD or death, whichever occurs 
first, for safety and response duration (Section 8.4). Participants with stable disease (SD) 
or progressive disease (PD) will be followed for 30 days after treatment discontinuation. 

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Participants removed from study treatment for unacceptable adverse event(s) will be 
followed at least weekly until resolution or stabilization of the adverse event, after which 
they will be followed according to their response status. 
4.6 
Criteria for Removal from Treatment 
Participants will be removed from study treatment when any of the criteria listed in 
Section 4.4 applies. The reason for study treatment removal and the date the participant 
was removed must be documented in the Off Protocol Treatment Form in Advantage 
eClinical. 

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5.0 
DOSING DELAYS/DOSE MODIFICATIONS 
5.1 
Dose Modifications for Pomalidomide 
5.1.1 Dose reduction steps 
Table 5-1. Pomalidomide Dose Reduction Steps 
Dose Level 
Dose and Schedule 
Dose level 1 (starting dose) 
4 mg daily on Days 1-21 every 28 days 
Dose level -1 
3 mg daily on Days 1-21 every 28 days 
5.1.2 Instructions for initiation of a new cycle 
A new course of treatment may begin on the scheduled day 1 of a new cycle if: 
• The ANC is ≥ 1,000 cells/mm³ (1.0 x 109/L); The platelet count is ≥ 50,000 
cells/mm³ (50.0 x 109/L); 
• Any drug-related rash or neuropathy that may have occurred has resolved to ≤ 
Grade 1 severity; 
• Any other drug related adverse events that may have occurred have resolved to 
≤ Grade 2 severity. 
If these conditions are not met on day 1 of a new cycle, the participant will be 
evaluated weekly and a new cycle of treatment will not be initiated until the toxicity 
has resolved as described above. If pomalidomide dosing was halted during the 
previous cycle and was restarted with a one-level dose reduction without requiring 
an interruption for the remainder of the cycle, then that reduced dose level will be 
initiated on day 1 of the new cycle. 
Unless otherwise specified in this section, if any Grade 3 or 4 toxicity persists for 
longer than two weeks after withholding pomalidomide, pomalidomide will be 
stopped permanently. 
5.1.3 Instructions for dose modifications or interruption during a cycle 
Note: If the site investigator has compelling evidence that the toxicity is NOT 
related to the study drugs or is not clinically significant (e.g., alopecia, 
electrolyte abnormalities that can be corrected with supplementation), then 
management of drug dosing is at the discretion of the site investigator after 
consultation with the study chair(s). Table 5-2. Dose Modifications For Non-
Hematologic Toxicity 
Toxicity 
Dose Modification 
Rash = Grade 3 
Hold dose for remainder of cycle. Decrease by 
one dose level when dosing restarted at next 
cycle (rash must resolve to ≤ Grade 1). 

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Toxicity 
Dose Modification 
Rash = Grade 4 or bullous 
dermatitis (any grade) 
Discontinue participant from pomalidomide 
treatment regimen. 
Stevens-Johnson Syndrome 
(any Grade) 
Discontinue participant from pomalidomide 
treatment regimen. 
Anaphylaxis (any Grade) 
Discontinue participant from pomalidomide 
treatment regimen. 
Constipation ≥ Grade 3 
Hold dose for remainder of cycle. Initiate bowel 
regimen. Decrease by one dose level when 
dosing restarted at next cycle (constipation must 
resolve to ≤ Grade 2). 
Thromboembolism event ≥ 
Grade 3 
Hold dose for remainder of cycle. Initiate 
anticoagulation treatment. Maintain dose level 
when dosing restarted at next cycle at discretion 
of treating physician. 
Hypo/hyperthyroidism ≥ 
Grade 2 
Hold dose for remainder of cycle. Initiate 
appropriate medical therapy. Maintain dose 
level when dosing restarted at next cycle at 
discretion of treating physician. 
Peripheral neuropathy = 
Grade 3 
Hold dose for remainder of cycle. Decrease by 
one dose level when dosing restarted at next 
cycle (neuropathy must resolve to ≤ Grade 1). 
Peripheral neuropathy = 
Grade 4 
Discontinue participant from pomalidomide 
treatment regimen. 
Other ≥ Grade 3 
pomalidomide-related 
adverse events 
Hold dose for remainder of cycle. Decrease by 
one dose level when dosing restarted at next 
cycle (adverse event must resolve to ≤ Grade 2). 
Dose modifications for non-hematologic toxicity 
Grade 3 rash or peripheral neuropathy 
If a participant experiences a new Grade 3 rash or peripheral neuropathy, 
pomalidomide must be withheld until the toxicity has resolved to ≤ Grade 1. If the 
participant is receiving 4 mg/day, the daily dose should be reduced by one dose 
level, to dose level -1 (3 mg/day). If Grade 3 toxicity recurs in a participant 
receiving 3 mg/day, pomalidomide treatment will be stopped. 
If any participant experiences Steven-Johnson Syndrome, anaphylaxis, or Grade 4 
peripheral neuropathy, pomalidomide must be discontinued. 

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All other Grade 3/4 non-hematologic toxicities 
If a participant experiences Grade 3/4 non-hematologic toxicity, pomalidomide 
must be withheld until the toxicity has resolved to ≤ Grade 2. Participants receiving 
4 mg/day may then have treatment resumed at dose level -1 (3 mg/day). If the Grade 
3/4 toxicity occurs or recurs at dose level -1, pomalidomide treatment will be 
stopped. 
 
Dose modifications for hematologic toxicity 
Grade 1/2 
There will be no dose interruptions or reductions for Grade 1 or 2 hematological 
toxicity. 
Grade 3/4 thrombocytopenia 
If the participant experiences Grade 3 or 4 thrombocytopenia (platelet count 
decrease), defined as a platelet count < 50 x 109/L, pomalidomide must be withheld 
until the toxicity has resolved to ≤ Grade 2. Participants receiving 4 mg/day may 
then have treatment resumed at dose level -1 (3 mg/day). If Grade 3 or 4 
thrombocytopenia occurs or recurs at dose level -1, pomalidomide treatment will 
be stopped permanently. If, at any time, Grade 3 or 4 thrombocytopenia persists for 
longer than two weeks after withholding pomalidomide, pomalidomide will be 
stopped permanently. 
Grade 3/4 neutropenia (see Figure 5-1) 
If a participant experiences Grade 3 or 4 neutropenia (absolute neutrophil count 
decrease), defined as a calculated ANC < 1.0 x 109/L, treatment with pomalidomide 
must be withheld. If available, growth factor (filgrastim or pegfilgrastim) may be 
started at standard doses (see Manual of Procedures (MOP) for acceptable dosing 
regimens). NOTE: Growth factors will not be provided by the study. If the ANC 
returns to ≤ Grade 2 within 1 week without any additional toxicity (i.e., fever), 
treatment with pomalidomide may continue without dose modification with 
continued growth factor support in all subsequent treatment cycles. In participants 
receiving growth factor support, if the ANC fails to return to ≤ Grade 2 within one 
week, or if additional toxicity is seen (i.e., fever), or if ≥ Grade 3 neutropenia recurs 
in a participant on pomalidomide with growth factor support, participants receiving 
4 mg/day may then have treatment resumed at dose level -1 (3 mg/day). If the Grade 
3 or 4 neutropenia occurs or recurs at dose level -1, pomalidomide treatment will 
be stopped. 
If growth factors are not available or cannot be provided on a sustained basis for all 
subsequent treatment cycles, pomalidomide must be withheld until the toxicity has 
resolved to ≤ Grade 2. Participants receiving 4 mg/day may then have treatment 
resumed at dose level -1 (3 mg/day). If the Grade 3 or 4 neutropenia occurs or recurs 
at dose level -1, pomalidomide treatment will be stopped permanently. 
If, at any time, Grade 3 or 4 neutropenia persists for longer than two weeks after 

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withholding pomalidomide, pomalidomide will be stopped permanently. 
Grade 1-4 anemia 
No dose reductions will be performed for Grade 1-4 anemia. Participants who 
develop anemia may be transfused at the discretion of the investigator. 

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Figure 5-1. Dose Modification For and Management of Neutropenia With/Without G-CSF 
 
* Available implies that sufficient supplies will be available to treat with G-CSF on all subsequent cycles 
using 300 mcg daily for five consecutive days during Days 22-28 of each cycle. 

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6.0 
ADVERSE EVENTS: LIST AND REPORTING REQUIREMENTS 
AE monitoring and reporting is a routine part of every clinical trial. The following list of 
AEs (Section 6.1) and the characteristics of an observed AE (Section 6.2) will determine 
whether the event requires expedited reporting in addition to routine reporting (via 
Advantage eClinical). All adverse event reporting will be conducted via Advantage 
eClinical for this protocol. 
The CTEP Version 5.0 of the NCI Common Terminology Criteria for Adverse Events 
(CTCAE) will be utilized for AE reporting. The CTEP Version 5.0 of the CTCAE is 
identified and located on the CTEP website at 
http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm. 
All appropriate treatment areas should have access to a copy of the CTEP Version 5.0 of 
CTCAE. 
6.1 
Comprehensive Adverse Events and Potential Risks list (CAEPR) for Pomalidomide 
(CC-4047, NSC 767909) 
The Comprehensive Adverse Events and Potential Risks list (CAEPR) provides a single 
list of reported and/or potential adverse events (AE) associated with an agent using a 
uniform presentation of events by body system. In addition to the comprehensive list, a 
subset, the Specific Protocol Exceptions to Expedited Reporting (SPEER), appears in a 
separate column and is identified with bold and italicized text. This subset of AEs (SPEER) 
is a list of events that are protocol specific exceptions to expedited reporting to NCI (except 
as noted below). Refer to the 'CTEP, NCI Guidelines: Adverse Event Reporting 
Requirements' 
http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/aeguidelines.pd
f for further clarification. Frequency is provided based on 2133 patients. Below is the 
CAEPR for Pomalidomide (CC-4047). 
NOTE: Report AEs on the SPEER ONLY IF they exceed the grade noted in parentheses 
next to the AE in the SPEER.  If this CAEPR is part of a combination protocol using 
multiple investigational agents and has an AE listed on different SPEERs, use the lower of 
the grades to determine if expedited reporting is required. 
Version 2.4, May 22, 20221 
 
 Adverse Events with Possible  
 Relationship to Pomalidomide (CC-4047)2 
 (CTCAE 5.0 Term) 
[n= 2133] 
 
 
 Specific Protocol Exceptions to Expedited 
Reporting (SPEER)  
 
Likely (>20%) 
Less Likely (<=20%) 
Rare but Serious (<3%)  
BLOOD AND LYMPHATIC SYSTEM DISORDERS 
  
Anemia3 
 
 
 Anemia3 (Gr 2) 
CARDIAC DISORDERS 
  
 
 
Myocardial infarction4 
  
GASTROINTESTINAL DISORDERS 
  
 
Constipation 
 
 Constipation (Gr 2) 
 
Diarrhea 
 
 Diarrhea (Gr 2) 
 
 
Nausea 
 Nausea (Gr 2) 
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS 
  

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 Adverse Events with Possible  
 Relationship to Pomalidomide (CC-4047)2 
 (CTCAE 5.0 Term) 
[n= 2133] 
 
 
 Specific Protocol Exceptions to Expedited 
Reporting (SPEER)  
 
Likely (>20%) 
Less Likely (<=20%) 
Rare but Serious (<3%)  
 
Edema limbs 
 
 Edema limbs (Gr 2) 
 
Fatigue 
 
 Fatigue (Gr 2) 
 
Fever 
 
 Fever (Gr 2) 
 
 
Sudden death NOS 
  
HEPATOBILIARY DISORDERS 
  
 
 
Hepatic failure 
  
IMMUNE SYSTEM DISORDERS 
  
 
 
Anaphylaxis 
  
INFECTIONS AND INFESTATIONS 
  
 
Infection5 
 
 Infection5 (Gr 2) 
\INVESTIGATIONS 
  
 
Alanine aminotransferase 
increased 
 
  
 
Blood bilirubin increased 
 
  
 
Lymphocyte count decreased  
  
Neutrophil count decreased  
 
 Neutrophil count decreased (Gr 2)  
 
Platelet count decreased 
 
 Platelet count decreased (Gr 2) 
METABOLISM AND NUTRITION DISORDERS 
  
 
 
Anorexia 
 Anorexia (Gr 2) 
 
Hyperkalemia 
 
  
 
Hyponatremia 
 
  
 
 
Tumor lysis syndrome 
  
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS 
  
 
Back pain 
 
  
 
 
Bone pain 
 Bone pain (Gr 2) 
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS 
AND POLYPS) 
  
 
 
Neoplasms benign, malignant 
and unspecified (incl cysts and 
polyps) - Other (second 
primary malignancies) 2 
  
 
 
Treatment related secondary 
malignancy2 
  
NERVOUS SYSTEM DISORDERS 
  
 
Depressed level of 
consciousness 
 
  
 
 
Dizziness 
 Dizziness (Gr 2) 
 
 
Dysesthesia 
  
 
 
Paresthesia 
  
 
Peripheral sensory neuropathy  
  
 
 
Nervous system disorders   - 
Other (progressive multifocal 
leukoencephalopathy) 
  
 
 
Stroke4 
  
PSYCHIATRIC DISORDERS 
  
 
Confusion 
 
  
 
 
Hallucinations 
  
RENAL AND URINARY DISORDERS 
  

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 Adverse Events with Possible  
 Relationship to Pomalidomide (CC-4047)2 
 (CTCAE 5.0 Term) 
[n= 2133] 
 
 
 Specific Protocol Exceptions to Expedited 
Reporting (SPEER)  
 
Likely (>20%) 
Less Likely (<=20%) 
Rare but Serious (<3%)  
 
Acute kidney injury 
 
  
 
Urinary retention 
 
  
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS 
  
 
 
Cough 
 Cough (Gr 2) 
 
 
Dyspnea 
 Dyspnea (Gr 2) 
 
 
Pneumonitis 
  
SKIN AND SUBCUTANEOUS TISSUE DISORDERS 
  
 
 
Rash maculo-papular 
 Rash maculo-papular (Gr 2) 
 
 
Skin and subcutaneous tissue 
disorders - Other (DRESS 
syndrome) 
  
 
 
Stevens-Johnson syndrome2 
  
 
 
Toxic epidermal necrolysis 
  
VASCULAR DISORDERS 
  
 
 
Thromboembolic event4 
  
 
1This table will be updated as the toxicity profile of the agent is revised.  Updates will be distributed to all 
Principal Investigators at the time of revision.  The current version can be obtained by contacting 
PIO@CTEP.NCI.NIH.GOV.  Your name, the name of the investigator, the protocol and the agent should be 
included in the e-mail. 
2While not observed in human trials of pomalidomide, teratogenic effects (birth defects), thromboembolic 
events increases in secondary malignancy, tumor lysis syndrome, Stevens-Johnson syndrome, and 
thyroiditis/hypothyroidism are known events for this class of agents that include thalidomide and 
lenalidomide. 
3Sickle cell crises in patients with SCD is a rare but serious event.  
4Venous thromboembolic events (e.g., deep vein thrombosis and pulmonary embolism) and arterial 
thromboembolic events (e.g., myocardial infarction and stroke) have been observed to occur more frequently 
in multiple myeloma patients treated with pomalidomide and dexamethasone. 
 5Infection includes all 75 sites of infection under the INFECTIONS AND INFESTATIONS SOC. 
Adverse events reported on Pomalidomide (CC-4047) trials, but for which there is insufficient evidence 
to suggest that there was a reasonable possibility that Pomalidomide (CC-4047) caused the adverse 
event: 
BLOOD AND LYMPHATIC SYSTEM DISORDERS - Blood and lymphatic system disorders - Other 
(sickle cell anemia with crisis)3; Febrile neutropenia 
CARDIAC DISORDERS - Atrial fibrillation; Cardiac arrest; Heart failure; Sinus tachycardia 
EAR AND LABYRINTH DISORDERS - Vertigo 
EYE DISORDERS - Blurred vision; Eye disorders - Other (eyelid swelling) 
GASTROINTESTINAL DISORDERS - Abdominal pain; Colonic perforation; Dry mouth; Dyspepsia; 
Enterocolitis; Vomiting 
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - Chills; Death NOS; 
Disease progression; Malaise 
IMMUNE SYSTEM DISORDERS - Allergic reaction 

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INVESTIGATIONS - CD4 lymphocytes decreased; CPK increased; Creatinine increased; Weight gain; 
Weight loss; White blood cell decreased 
METABOLISM AND NUTRITION DISORDERS - Dehydration; Hypercalcemia; Hyperglycemia; 
Hyperuricemia; Hypocalcemia; Hypokalemia 
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS - Arthralgia; Chest wall pain; 
Generalized muscle weakness; Muscle cramp; Myalgia; Pain in extremity 
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - 
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other (multiple myeloma, 
myelofibrosis, progression of MM); Tumor pain 
NERVOUS SYSTEM DISORDERS - Dysphasia; Headache; Intracranial hemorrhage; Ischemia 
cerebrovascular; Seizure; Syncope; Tremor 
PSYCHIATRIC DISORDERS - Anxiety; Depression; Insomnia 
RENAL AND URINARY DISORDERS - Hematuria   
REPRODUCTIVE SYSTEM AND BREAST DISORDERS - Pelvic pain 
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - Epistaxis; Nasal congestion; 
Oropharyngeal pain; Postnasal drip; Productive cough; Pulmonary hypertension; Respiratory failure; 
Respiratory, thoracic and mediastinal disorders - Other (sputum discolored) 
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - Alopecia; Dry skin; Erythema multiforme; 
Hyperhidrosis; Pruritus 
VASCULAR DISORDERS - Vascular disorders - Other (hyperviscosity syndrome) 
Note: Pomalidomide (CC-4047) in combination with other agents could cause an exacerbation of any adverse 
event currently known to be caused by the other agent, or the combination may result in events never 
previously associated with either agent. 
6.2 
Classification of AEs by Severity and Relationship to Study Drug Administration 
6.2.1 Adverse event: Any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom or disease temporally associated with the use of a 
medical treatment or procedure regardless of whether it is considered related to the 
medical treatment or procedure (attribution of unrelated, unlikely, possible, 
probable, or definite). 
This includes the following: 
• AEs not previously observed in the participant that emerge during the protocol-
specified AE reporting period, including signs or symptoms associated with KS 
that were not present prior to study entry. 
• Complications that occur as a result of protocol interventions. 
• Preexisting medical conditions (other than the condition being studied) judged 
by the investigator to have worsened in severity or frequency, or changed in 
character during the protocol-specified AE reporting period. 
AEs will be followed for the participant’s medical care until resolved to the baseline 
condition or protocol completion; for chronic conditions, resolution may occur 
when the AE is stable with appropriate medical management. 
6.2.2 Life-threatening adverse event: Any AE that places the participant, in view of the 
Investigator, at immediate risk of death from the reaction. 

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6.2.3 Serious adverse event (SAE): Any AE occurring at any dose that results in any of 
the following outcomes: Death, a life-threatening AE, inpatient hospitalization or 
prolongation of existing hospitalization, a persistent or significant disability/ 
incapacity, or a congenital anomaly/birth defect. Important medical events that may 
not result in death, be life-threatening, or require hospitalization may be considered 
serious when, based upon appropriate medical judgment, they may jeopardize the 
participant and may require medical or surgical intervention to prevent one of the 
outcomes listed in this definition. 
6.2.4 Hospitalization: hospitalization for expedited AE reporting purposes is defined as 
an inpatient hospital stay equal to or greater than 24 hours. Hospitalization is used 
as an indicator of the seriousness of the AE and should ONLY be used for situations 
where the AE truly fits this definition and NOT for hospitalizations associated with 
less serious events. (e.g., a hospital visit where a patient is admitted for observation 
or minor treatment such as, hydration and released in less than 24 hours). 
Prolongation of hospitalization is defined as an extension of current hospitalization 
equal to or greater than 24 hours. 
Please note for hospitalization – All hospitalizations (or prolongation of existing 
hospitalization) for medical events equivalent to CTCAE Grade 3, 4, 5 must be 
reported regardless of the requirements for Phase of study, expected or unexpected, 
and attribution. For example, do not report an admission for pharmacokinetic 
sampling, but do report an admission for a myocardial infarction. 
6.2.5 Toxicity: Toxicity is a term NOT clearly defined by regulatory organizations. 
Toxicity has been described as an AE that has an attribution of possibly, probably 
or definitely related to investigational treatment. To minimize confusion the NCI 
would recommend that the term toxicity NOT be utilized for AE reporting 
purposes. The CTCAE continues to use the term ‘toxicity’ because of familiarity. 
6.2.6 Unexpected adverse event: Any AE that is not listed in available sources including 
the package insert, the Investigator’s Brochure, or the protocol, or is not consistent 
with the severity or specificity of the risk information described in the available 
sources, or is not consistent with the severity or specificity of the risk information 
described in the available sources. 
6.2.7 CTEP Adverse Event Reporting System (CTEP-AERS): An electronic system for 
expedited submission of AE reports. A SAE reporting form in Advantage eClinical 
will be used in lieu of CTEP-AERS for this trial. 
6.2.8 Attribution: An assessment of the relationship between the AE and the medical 
intervention. The CTCAE does not define an AE as necessarily “caused by a 
therapeutic intervention.” After naming and grading the event, the clinical 
investigator must assign an attribution to the AE using the following attribution 
categories: 
Table 6-1: Attribution 
RELATIONSHIP 
ATTRIBUTION 
DESCRIPTION 
Unrelated 
to Unrelated  
The AE is clearly NOT related to the 

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investigational 
agent/intervention 
intervention  
Unlikely 
The AE is doubtfully related to the 
intervention  
Related 
to 
investigational 
agent/intervention 
Possible  
The AE may be related to the 
intervention  
Probable 
The AE is likely related to the 
intervention  
Definite 
The AE is clearly related to the 
intervention  
NOTE: AEs listed as ‘possibly, probably, or definitely’ related to the 
investigational agent/intervention are considered to have a suspected ‘reasonable 
causal relationship’ to the investigational agent/intervention (ICH E2A). For 
routine adverse event reporting purposes on this protocol, “attribution” defines the 
relationship 
between 
the 
adverse 
event 
and 
the 
investigational 
agent(s)/intervention. 
6.3 
Expedited Adverse Event Reporting 
6.3.1 Expedited AE reporting for this study must use Advantage eClinical. The reporting 
procedures to be followed are presented in this section and will align with the 
principles for SAE reporting in the “CTEP, NCI Guidelines: Adverse Event 
Reporting Requirements” which can be downloaded from the CTEP home page 
(http://ctep.cancer.gov). These requirements are briefly outlined in the table below 
(Section 6.3.3). 
A 24-hour notification is to be made to the AMC ODMC by telephone at 301-251-
1161, only when Internet connectivity is disrupted. Once Internet connectivity is 
restored, a 24-hour notification phoned in must be entered electronically into 
Advantage eClinical by the original submitter at the site. 
6.3.2 Advantage eClinical is programmed for automatic electronic distribution of SAE 
reports to the following individuals: the AMC ODMC, AMC Medical Monitor, 
Protocol Chairs, and the Principal Investigator at the institution 
6.3.3 Expedited reporting guidelines 
Investigators must report ALL SAEs (as defined in Section 6.2.3) that occur from 
enrollment through 30 days following treatment discontinuation to the AMC and 
IRBs as required. The investigator’s initial report to the AMC will be made using 
the Adverse Event form in Advantage eClinical within 24 hours of awareness of 
the event, followed by a completed SAE form as soon as possible, and in no more 
than 5 calendar days of awareness. 
After 30 days following treatment discontinuation, SAEs will only be reported in 
the SAE form if determined by the investigator to have an attribution to the 
investigational agent of possible, probable, or definite. 
Note: A death on study requires both routine and expedited reporting regardless of 

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causality. Attribution to treatment or other cause must be provided. 
Death due to progressive disease should be reported as Grade 5 “General 
disorders and administration site conditions – Disease Progression.” Evidence 
that the death was a manifestation of underlying disease (e.g., radiological changes 
suggesting tumor growth or progression: clinical deterioration associated with a 
disease process) should be submitted. 
6.3.4 Expedited reporting for pregnancy 
Female participants 
Pregnancies and suspected pregnancies (including a positive pregnancy test 
regardless of age or disease state) of a female participant or the partner of a male 
participant occurring while the participant is on pomalidomide or within 28 days 
after the participant’s last dose, are considered immediately reportable events. 
Pomalidomide is to be discontinued immediately. The pregnancy, suspected 
pregnancy, or positive pregnancy test must be reported via Advantage eClinical and 
CTEP-AERS as a Grade 4 event under: SOC pregnancy, puerperium and perinatal 
conditions; adverse event: pregnancy, puerperium and perinatal conditions-
other, fetal exposure. 
The female participant should be referred to an obstetrician-gynecologist, 
preferably one experienced in reproductive toxicity for further evaluation and 
counseling. Contact details of the healthcare provider who is following the 
pregnancy should be provided to the Investigator. 
The Investigator will follow the female participant until completion of the 
pregnancy, and must make an amendment to the initial pregnancy report 
immediately regarding the outcome of the pregnancy and neonatal status (either 
normal or abnormal outcome). Infants must be followed through 1 year following 
birth, especially for developmental anomalies. 
If the outcome of the pregnancy was abnormal (including spontaneous or 
therapeutic abortion, fetal demise and congenital abnormalities), the Investigator 
should report the abnormal outcome as an amendment to the initial pregnancy 
report as soon as the as the Investigator has knowledge of the outcome. 
All neonatal deaths and neonatal complications that occur within 28 days of birth 
should be reported, without regard to causality, as an amendment to the initial 
pregnancy report. In addition, any infant death after 28 days that the Investigator 
suspects is related to the in utero exposure to the pomalidomide should also be 
reported as an amendment within 24 hours of the Investigator’s knowledge of the 
event. 
Male participants 
If a female partner of a male participant taking investigational product becomes 
pregnant, the male participant taking pomalidomide should notify the Investigator, 
and the pregnant female partner should be advised to call her healthcare provider 
immediately. 
6.3.5 Expedited reporting to regulatory authorities 

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Each clinical center is responsible for ensuring that any AE or SAE that requires 
reporting to its IRB or respective national regulatory authority is completed in 
accordance with legal and regulatory timelines. 
As this trial will not be conducted in the U.S. and will not support a marketing 
application or change in labeling or advertising for the drug, the trial is exempt from 
the requirement for an IND. No SAE reporting to FDA is required. In the event that 
any serious adverse events reported on this trial are determined to have a reasonable 
possibility of a causal relationship to the study drugs, the SAE will be reported to 
FDA using its voluntary reporting mechanism (MedWatch Online Voluntary 
Reporting Form). Voluntary SAE reporting will be performed by the AMC ODMC 
following the medical monitor’s determination that the AE meets these criteria. 
6.4 
Routine Adverse Event Reporting 
With the exception of the cases noted below, all adverse events that occur within 
timeframes defined in protocol Section 6.4.2 must be reported in routine study data 
submissions. 
6.4.1 Additional protocol-specific routine adverse event reporting exclusions 
All Grade 1 hematologic toxicities (Grade 1 thromboembolic events are excluded), 
all Grade 1 asymptomatic laboratory abnormalities, and Grade 2 anemia are not 
required to be reported in the Adverse Event Form in Advantage eClinical. These 
adverse events must be recorded in the source documents only. 
6.4.2 Timeline for routine adverse event reporting 
Adverse events that occur following the first dose of protocol treatment to 30 days 
post treatment discontinuation (Day 28 of the final cycle of treatment) must be 
recorded in the source documents and reported in an Adverse Event Form, unless 
specifically excluded in Section 6.4.1. AEs must be reported if the AE began any 
time within 30 days of completing study treatment. Additionally, if a site learns of 
any occurrence of death, cancer or fetal anomaly that is possibly, probably, or 
definitely related to the drug at any time after the study is closed, the event should 
be reported to the AMC through Advantage eClinical within 24 hours of when the 
investigator learns of the event. 
6.5 
Secondary Malignancy 
A secondary malignancy is a cancer caused by treatment for a previous malignancy (e.g., 
treatment with investigational agent/intervention, radiation, or chemotherapy). A 
secondary malignancy is not considered a metastasis of the initial neoplasm. 
CTEP requires all secondary malignancies that occur following treatment with an agent 
under an NCI Investigational New Drug (IND) or Investigational Device Exemption (IDE) 
application be reported expeditiously via CTEP-AERS. Three options are available to 
describe the event: 
• Leukemia secondary to oncology chemotherapy (e.g., acute myelocytic leukemia 
[AML]) 
• Myelodysplastic syndrome (MDS) 

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• Treatment-related secondary malignancy 
Any malignancy possibly related to cancer treatment (including AML/MDS) should also 
be reported via the routine reporting mechanisms outlined in each protocol. 
6.6 
Second Malignancy 
A second malignancy is one unrelated to the treatment of a prior malignancy (and is NOT 
a metastasis from the initial malignancy). Second malignancies require ONLY routine 
adverse event reporting. 

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7.0 
PHARMACEUTICAL INFORMATION 
A list of the adverse events and potential risks associated with the investigational or 
commercial agents administered in this study can be found in Section 6.1. 
7.1 
Pomalidomide (NSC # 767909) 
Pomalidomide is provided to the investigator via donation from Celgene. See the study 
Manual of Procedures for ordering information. 
NOTE: 
Before pomalidomide is dispensed, a patient must 1) have a negative pregnancy test (if 
applicable) and 2) be counseled by a trained counselor. Pharmacists may be trained 
counselors (see Pomalidomide Counselor Program Site Counselor Identification Form in 
the protocol). Only a 21-day supply may be dispensed to a participant at one time. 
7.1.1 Chemical name: 4-amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione 
7.1.2 Other names: CC-4047, Pomalyst 
7.1.3 Classification: immunomodulatory agent 
7.1.4 CAS registry number: 19171-19-8 
7.1.5 Molecular formula: C13H11N3O4, M.W.: 273.24 
7.1.6 Mode of action: Pomalidomide induces cell cycle arrest and apoptosis. In vitro 
studies show immunomodulatory activity on T cell and NK cell mediated immunity 
and inhibition of certain pro-inflammatory cytokines. Pomalidomide can overcome 
some instances of lenalidomide resistance, which makes it an attractive agent for 
further drug development. Current investigations are underway to more precisely 
understand pomalidomide’s multiple mechanisms of action. 
7.1.7 Description: yellow solid with melting point of 319° C 
7.1.8 How supplied: Celgene supplies and AMC distributes pomalidomide hard gelatin 
capsules in the following strengths, sizes and descriptions: 3 mg (size 2, dark blue 
and green) and 4 mg (dark blue and blue). Excipients include mannitol, 
pregelatinized starch, and sodium stearyl fumarate. 
Pomalidomide capsules are supplied in high-density polyethylene (HDPE) 
containers fitted with induction seals and child-resistant plastic closures. Each 
bottle contains 21 capsules. 
7.1.9 Storage: Store at 20°C-25°C (68°F-77°F) [USP Controlled Room Temperature]. 
Excursions are permitted to 15°C-30°C (59°F-86°F). 
7.1.10 Stability: Celgene has run stability tests at 30°C/75% humidity (long term 3 years) 
and at 40°C/75% humidity conditions (accelerated for 6 months). 
7.1.11 Route of administration: Take by mouth with or without food. Capsules should be 
swallowed whole and taken with water and not crushed, chewed or opened. If 
participants miss a dose, the dose may still be taken up to 12 hours after the time 
they normally would take it. If more than 12 hours have elapsed, the dose should 

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be skipped. Take the next dose at the usual time. Participants should not take 2 
doses to make up for the one they missed. 
7.1.12 Dispensing: Dispense up to a 21-day supply at one time. Sites may not mail 
pomalidomide to participants. 
7.1.13 Patient care implications and counseling: 
Risks associated with pregnancy 
Pomalidomide is structurally related to thalidomide. Thalidomide is a known 
human teratogenic active substance that causes severe life-threatening birth defects. 
An embryofetal development study in animals indicates that pomalidomide 
produced malformations in the offspring of female monkeys who received the drug 
during pregnancy. The teratogenic effect of pomalidomide in humans cannot be 
ruled out. Therefore, a risk minimization plan to prevent pregnancy must be 
observed. 
Definition of female of childbearing potential (FCBP) 
This protocol defines a female of childbearing potential as a sexually mature 
woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy, or 2) 
has not been naturally postmenopausal (amenorrhea following cancer therapy does 
not rule out childbearing potential) for at least 24 consecutive months (i.e., has had 
menses at any time in the preceding 24 consecutive months). 
Before starting study drug 
Female Participants: FCBP must have two negative pregnancy tests (minimum 
sensitivity of 25 mIU/mL) prior to starting study drug. The first pregnancy test must 
be performed within 14 days prior to the start of study drug and the second 
pregnancy test must be performed within 24 hours prior to the start of study drug. 
The participant may not receive study drug until the Investigator has verified that 
the results of these pregnancy tests are negative. 
Male Participants: Must agree to use a latex condom during sexual contact with 
females of childbearing potential while participating in the study and for at least 28 
days following discontinuation from the study even if he has undergone a 
successful vasectomy. 
All Participants: Only enough pomalidomide for one cycle of therapy may be 
dispensed with each cycle of therapy. 
If pregnancy or a positive pregnancy test does occur in a study participant or the 
partner of a male study participant during study participation, pomalidomide must 
be immediately discontinued. 
Counseling 
Participants will be counseled by a qualified healthcare professional (including but 
not limited to, nurses, pharmacists, and physicians). Two healthcare professionals 
at each site will be trained by Celgene in requirements specific to counseling of 
participants. Refer to specific protocol sections for more information about training 
requirements. 

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Once trained, these healthcare staff will counsel participants prior to medication 
being dispensed to ensure that the participant has complied with all requirements 
including use of birth control and pregnancy testing (FCBP) and that the participant 
understands the risks associated with pomalidomide. This step will be documented 
with a completed Pomalidomide Education and Counseling Guidance Document 
(Appendix VIII) and no drug will be dispensed until this step occurs. Counseling 
includes verification with the participant that required pregnancy testing was 
performed and results were negative. A Pomalidomide Information Sheet 
(Appendix X) will be supplied with each medication dispense. 
Tobacco use 
Patients should be advised that smoking tobacco may reduce the efficacy of 
pomalidomide. 
Overdose 
Pomalidomide can be removed by hemodialysis. 
7.1.14 Potential drug interactions: Pomalidomide is metabolized mostly by CYP 1A2 and 
3A and is substrate for P-glycoprotein (P-gp). In vitro studies showed a significant 
plasma increase when strong CYP 1A2, 3A and P-gp inhibitors were given 
simultaneously. Avoid concomitant administration of strong inducers and 
inhibitors of CYP 1A2, 3A and P-gp in participants receiving pomalidomide. 
Closely monitor INR when participants receive concomitant warfarin and 
dexamethasone. Refer to the protocol for pomalidomide dose modifications. 
Pomalidomide does not inhibit CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 
3A4/5 in vitro. It is also not an inhibitor of P-gp, BCRP, OATP1B1, OATP1B3, 
OAT1, OAT3, or OCT2. Pomalidomide does not induce CYP1A2, 2B6, 2C9, 
2C19, or 3A4/5 in vitro. 
7.1.15 Special handling: Pomalidomide should not be handled by non-patient FCBP or 
non-patient partners of FCBP unless gloves are worn. If any contact with a broken 
pomalidomide capsule or the medicine in the capsule occurs, the exposed area 
should be washed immediately and thoroughly with soap and water. 
7.2 
Drug Orders, Transfers, Returns, and Accountability 
The Investigator, or a responsible party designated by the Investigator, must maintain a 
careful record of the inventory and disposition of all drugs received using the NCI Oral 
Drug Accountability Record Form (DARF) (available on the CTEP home page 
(http://ctep.cancer.gov)). The DARFs document the drug delivery date to the site, inventory 
at the site, use by each study participant. Store and maintain separate NCI Investigational 
Agent Accountability Records for each agent, strength, formulation and ordering 
investigator on this protocol. The investigator will ensure that the drugs are used only in 
accordance with this protocol. 
Drug will be shipped through a third party vendor. Instructions for drug ordering are 
available on the AMC website (www.AIDSCancer.org). 

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8.0 
CLINICAL AND LABORATORY EVALUATIONS 
Schedules shown in the Study Calendar below are provided in Appendix I. 
8.1 
Screening Evaluations 
Screening evaluations are used to determine eligibility and are to be conducted within 21 
days before treatment segment enrollment, unless otherwise specified. Participating sites 
must ensure a participant meets all eligibility criteria before completing the protocol-
specific eligibility checklist in Advantage eClinical. 
8.1.1 Informed consent must be collected prior to performing any screening evaluations. 
8.1.2 Medical history, including history of AIDS-defining illnesses, history of smoking 
and current tobacco use, performance status, life expectancy, any prior receipt of 
thalidomide or its analogs, history of other malignancies, history of major 
cardiovasular events, history of coagulation disorders per Section 3.2.13, and 
participant demographic information. 
8.1.3 Medication history, including all current ART and prior ART regimens. Per Section 
3.1.8 the ART regimen must be stable for 12 weeks prior to study enrollment. All 
prescription and non-prescription medications, including over-the-counter 
medications, alternative therapies, herbal medicines/tea, and dietary supplements 
taken within 14 days prior to study enrollment must be recorded. 
8.1.4 Complete physical examination including vital signs, height, weight, assessment of 
signs and symptoms,, neuropathy evaluation (i.e., pain, aching, or burning in hands 
or feet), and performance status. 
8.1.5 Biopsy diagnostic of KS at any time prior to study enrollment. The biopsy specimen 
must be available for review (including performing or reviewing latency-associated 
nuclear antigen (LANA) stains) and confirmation by an AMC-approved 
pathologist. Specimens for this review must conform to the requirements listed in 
Appendix V. 
8.1.6 Tumor assessment to determine that participant does not have visceral disease 
requiring cytotoxic chemotherapy. 
8.1.7 HIV plasma quantitative RNA viral load via HIV quantitative polymerase chain 
reaction (PCR) within 12 weeks of enrollment. 
8.1.8 Chest X-ray (CXR) to evaluate for pulmonary KS. If available and clinically 
indicated, computed tomography (CT) of the lung may be performed to verify chest 
X-ray findings. 
8.1.9 Pregnancy testing if FCBP by beta-human chorionic gonadotropin (b-HCG) with a 
sensitivity of at least 25 mIU/mL within 14 days prior to enrollment. 
8.1.10 Complete blood count (CBC) with differential and platelets within 7 days prior to 
enrollment. 
8.1.11 Serum chemistries including sodium, potassium, chloride, bicarbonate, phosphate, 
glucose, creatinine, albumin, AST, ALT, alkaline phosphatase, and total bilirubin 
within 7 days prior to enrollment. 

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8.2 
Baseline Evaluations 
Baseline evaluations are to be conducted within 7 days prior to starting treatment, unless 
otherwise specified below. In the event that the participant’s condition is deteriorating, 
laboratory evaluations should be repeated within 48 hours prior to initiation of the first 
cycle of therapy. 
8.2.1 Enrollment into Advantage eClinical Treatment Segment once all eligibility criteria 
are confirmed. 
8.2.2 Interim medical history, including HIV-related and AIDS-defining events. 
8.2.3 Review of concurrent medications as defined in Section 8.1.3. 
8.2.4 Complete physical examination including vital signs, weight, assessment of signs 
and symptoms, neuropathy evaluation (i.e., pain, aching, or burning in hands or 
feet), and performance status. 
8.2.5 Tumor assessments with photographic record must be performed prior to initiating 
treatment. These may be performed on Day 1, but no earlier than 7 days before 
initiating study treatment. If the screening tumor assessments with photographic 
record are performed within 7 days before initiating study treatment, the screening 
tumor assessments can be used as a baseline assessment. Tumor assessments and 
photographs should be performed as outlined in the KS Tumor Assessment MOP. 
8.2.6 Staging criteria: KS staging will be based on the modified AIDS Clinical Trials 
Group (ACTG) Oncology Committee Staging Criteria as outlined in Appendix 
XIII. 
8.2.7 HIV plasma quantitative RNA viral load via HIV quantitative PCR within 28 days 
before initiating study treatment.If the HIV viral load used to determine eligibility 
is performed within 28 days of the start of protocol therapy, the screening viral load 
can be used as a baseline test. The results of the baseline HIV viral load do not need 
to be available prior to the start of protocol therapy. 
A CD4 T cell count is required within 28 days prior to study treatment. 
8.2.8 Pregnancy prevention counseling for all participants before starting each new cycle 
of pomalidomide, as required at Appendix VII. Pregnancy testing if FCBP by b-
HCG with a sensitivity of at least 25 mIU/mL within 24 hours of starting 
pomalidomide. 
8.2.9 Whole blood collection for serum cytokine studies (one 7 mL red top tube) 
(Appendix XII) on day 1 prior to the first dose. 
8.3 
Evaluations During Treatment 
Except as noted, evaluations required to ensure safe and timely treatment may be conducted 
within three days prior to beginning cycles 2-12 of pomalidomide. 
8.3.1 KS Tumor Assessment will be performed prior to every cycle. 
8.3.2.1 For participants with known pulmonary KS at study entry, a CXR (and CT 
scan, if available and clinically indicated) will be repeated every third cycle. 
8.3.2.2 If during the pre-treatment assessment at cycle 7 day 1 the participant has 

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stable disease (SD) or progressive disease (PD) the participant must 
discontinue treatment. If the participant has a partial response (PR) or a 
complete response (CR), the participant may continue with treatment for up 
to 12 cycles. 
8.3.2 Photographic documentation will be completed at each visit when the KS response 
category changes (see KS Tumor Assessment MOP for lesion photography 
guidelines). 
8.3.3 Complete physical examination including vital signs, weight, assessment of signs 
and symptoms and toxicity, neuropathy evaluation (i.e., pain, aching, or burning in 
hands or feet), and performance status. 
8.3.4 Interim medical history, including HIV-related and AIDS-defining events. 
8.3.5 Assessment of adherence to ART (by participant report of missed doses). 
8.3.6 Assessment of adherence to study therapy. 
8.3.7 Review of concurrent medications. 
8.3.8 CBC with differential and platelets. 
8.3.9 Serum chemistries: sodium, potassium, chloride, bicarbonate, phosphate, glucose, 
creatinine, albumin, AST, ALT, alkaline phosphatase, and total bilirubin. 
8.3.10 HIV plasma quantitative RNA viral load via HIV quantitative PCR, and CD4 T cell 
count prior to cycles 2, 4, 7, and 10. 
8.3.11 Pregnancy prevention counseling for all participants before starting each new cycle 
of pomalidomide, as required at Appendix VII. Pregnancy testing if FCBP by beta-
HCG with a sensitivity of at least 25 mIU/mL within 24 hours of starting each cycle 
of pomalidomide. Weekly pregnancy testing for FCBP is required during the first 
cycle. If menstrual cycles are irregular, the pregnancy testing must occur weekly 
for the first 28 days and then every 10-14 days while on study. 
8.3.12 Whole blood collection for serum cytokine studies (one 7 mL red top tube) prior to 
treatment for cycle 3 day 1 and cycle 7 day 1 (Appendix XII). 
8.4 
Treatment Discontinuation Evaluations 
8.4.1 Participants who complete all treatment per-protocol or who discontinue protocol 
treatment early for any reason should have the following evaluations and laboratory 
tests within 1 week and again at 30 days (±7 days) after the last dose of protocol 
treatment, unless otherwise noted. 
8.4.1.1 KS tumor assessment, including re-evaluation of visceral disease if not 
already done while on study, and photographic documentation. 
8.4.1.2 Complete physical examination including vital signs, weight, assessment 
of signs and symptoms and toxicity, neuropathy evaluation (i.e., pain, 
aching, or burning in hands or feet), and performance status. 
8.4.1.3 Interim medical history, including HIV-related and AIDS-defining 
events. 

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8.4.1.4 Assessment of adherence to ART. 
8.4.1.5 Assessment of adherence to study therapy. 
8.4.1.6 Review of concurrent medications. 
8.4.1.7 CBC with differential and platelets. 
8.4.1.8 Serum chemistries: sodium, potassium, chloride, bicarbonate, phosphate, 
glucose, creatinine, albumin, AST, ALT, alkaline phosphatase, and total 
bilirubin. 
8.4.1.9 HIV plasma quantitative RNA viral load via HIV quantitative PCR, and 
CD4 T cell count within 1 week of last dose of protocol treatment. 
8.4.1.10 CXR (and CT if available/indicated) for participants who had either an 
abnormal CXR/CT at Screening or have clinical evidence for new 
pulmonary involvement. CXR/CT should only occur once following the 
last dose of protocol treatment. 
8.4.1.11 Pregnancy testing if FCBP by beta-HCG with a sensitivity of at least 25 
mIU/mL at study discontinuation, and at Day 28 (±7 days) following 
study drug discontinuation. If menstrual cycles are irregular, the 
pregnancy testing must occur at study discontinuation, and again at 14 and 
28 days (±7 days) after this date. 
8.4.1.12 Participants who discontinue treatment will have whole blood collection 
for serum cytokine studies (one 7 mL red top tube) within 1 week of last 
dose of protocol treatment (Appendix XII). 
8.4.1.13 Participants with stable disease (SD) or progressive disease (PD) at the 
time of treatment discontinuation will complete all study follow up at the 
30 day post-treatment visit and the Off-Study Summary Form will be 
completed. See Section 6.4.2 for the timeline for routine adverse event 
reporting. 
8.5 
Follow-up Evaluations 
Only participants who achieve PR or CR will have additional physical examinations 
repeated every 12 weeks (counting from the last day, Day 28, of the final cycle, ±2 weeks) 
for up to 48 weeks or until an earlier time of PD requiring additional treatment. AEs must 
be reported if the AE began any time within 30 days of completing study treatment. 
Additionally, if a site learns of any occurrence of death, cancer or fetal anomaly that is 
possibly, probably, or definitely related to the drug at any time after the study is closed, the 
event should be reported to the AMC through Advantage eClinical within 24 hours of when 
the investigator learns of the event. 
The following procedures should be performed during the follow-up visits: 
8.5.1 Complete physical examination including vital signs, signs and symptoms review, 
toxicity, neuropathy evaluation (i.e., pain, aching, or burning in hands or feet), and 
performance status. 
8.5.2 Review of interim medical history, including AIDS-defining events. 

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8.5.3 KS tumor assessment. 
8.5.4 At a participant’s final study visit, the Off-Study Summary Form will be completed. 

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9.0 
MEASUREMENT OF EFFECT 
All participants will be evaluated for KS response by physical examination as described in 
the KS Tumor Assessment MOP within three days prior to the first day of every cycle. See 
Appendix I for the KS Tumor Assessment schedule. 
CTEP-registered advanced practice clinicians who are non-physician investigators (i.e., NP 
or PA) may perform toxicity and response assessment as allowed per local licensure 
requirements for this study. 
Any non-physician investigator performing assessments on the study must be listed in the 
site delegation log and be CTEP-registered and IRB approved. 
9.1 
Definition of Response 
Response and progression will be evaluated in this study as follows: 
9.1.1 Complete response (CR): CR is defined as the absence of any detectable residual 
disease, including tumor-associated edema, persisting for at least 4 weeks. In some 
individuals, residual skin color changes may remain visible at one or more site(s) 
of lesions that were previously raised and/or red or violaceous. Suspected CR in 
those lesions refers only to residual macules (flat, non-palpable lesions) that are 
slightly darker than the surrounding normal skin. In the event such lesions are 
present in a participant otherwise believed to have a CR, biopsy of at least one such 
lesion is required in order to document the absence of malignant cells and to 
confirm CR. In the event that such a confirmatory biopsy is not performed and 
residual pigment persists, the response will be considered partial (PR). In 
participants in whom all detectable cutaneous disease has resolved and in whom 
there are no visible pigmented macules as described above, a confirmatory skin 
biopsy is not required. In participants known to have had visceral disease, an 
attempt at restaging with appropriate endoscopic or radiographic procedures should 
be made. 
NOTE: To classify a response as a CR, the participant must have a CR in both the 
cutaneous and noncutaneous (if applicable) sites of disease and no evidence of 
progression as defined by the above criteria. 
9.1.2 Partial response (PR): PR is defined as no new oral lesions or new or progressive 
visceral sites of involvement, or the appearance or worsening of tumor-associated 
edema (as defined in the AMC-100 MOP) or effusions or the development of five 
or more new cutaneous lesions in anatomic sites which were previously 
documented as having no evidence of cutaneous disease; AND 
• A 50% or greater decrease in the number of all lesions present at entry (either 
total body or in the representative areas) lasting for at least 4 weeks; OR 
• Complete flattening of at least 50% of all previously raised lesions (i.e., 50% of 
all nodular or plaque-like lesions become macules, either total body or in the 
representative areas) present at entry lasting for at least 4 weeks; OR 
• A 50% or greater decrease in the area of the cutaneous marker lesions compared 
with entry lasting for at least 4 weeks; OR 

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• A 50% or greater decrease in the number or size of all measurable oral or 
visceral lesions lasting for at least 4 weeks, without evidence for progression of 
cutaneous lesions; OR 
• Complete disappearance of non-measurable oral or visceral lesions lasting for 
at least 4 weeks, without evidence for progression of cutaneous lesions. 
NOTE: To classify a response as PR, the participant must have at least a PR in 
either the cutaneous or noncutaneous sites of disease, and no evidence of 
progression as defined in the above criteria. 
NOTE: Participants with residual tumor-associated edema or effusion who 
otherwise meet the criteria for CR will be classified as having a PR. 
9.1.3 Stable disease (SD) is defined as any response not meeting the criteria for CR, PR, 
or PD. 
9.1.4 Progressive disease (PD) is defined as follows: 
For participants with ≤50 cutaneous lesions 
PD is defined as any one or more of the following: 
• ≥25% increase in the area of the cutaneous marker lesions compared to entry or 
best response; 
• ≥25% increase in the total lesion count, or a minimum of five new lesions, 
whichever is greater, compared with entry or best response; 
• ≥25% increase in the number of raised lesions, or a minimum of five new raised 
lesions, whichever is greater, compared with entry or best response. 
NOTE: There are body sites where disease is particularly difficult to evaluate, and 
a few new lesions may be counted in spite of the fact that a participant is not actually 
progressing. For example, lesions of the foot, particularly those that are flat, are 
difficult to evaluate because their intensity may vary based on how much edema is 
present, how much the person walked the day before, how long his/her feet have 
been in a dependent position prior to the physical exam. 
For participants with >50 cutaneous lesions 
PD is defined as any one or more of the following: 
• ≥25% increase in the area of the cutaneous marker lesions compared to entry or 
best response; 
• ≥25% increase in the total number of lesions in the prospectively defined 
anatomic sites containing representative lesions; 
• a total of five new lesions in anatomic sites that were previously documented 
as having no evidence of cutaneous disease, 
• ≥25% increase in the number of raised lesions in the prospectively defined 
anatomic sites containing representative lesions (minimum of five raised 
lesions if there are very few raised lesions, for example <8) whichever is 

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greater. Photographic documentation of “gross” or significant progression, 
particularly in areas that were not being followed, will be of particular value. 
9.1.5 Noncutaneous progression (PD): Noncutaneous PD includes new oral or visceral 
sites of involvement or progression of oral or visceral disease or the development 
of new or increasing tumor-associated edema or effusion that interferes with the 
participant’s normal activities lasting for at least two consecutive evaluations. 
Progressive oral or visceral disease, for measurable and evaluable disease, should 
be analogous to cutaneous KS response criteria. 
Progressive edema is defined as the following: 
• An increase in non-pitting/woody edema in an upper or lower extremity 
associated with an increase in limb circumference of at least 3 cm from entry or 
best response, sustained for at least two consecutive evaluations, and measured 
at a fixed point on the extremity with respect to a bony landmark (e.g., 10 cm 
below the lower border of the patella); AND/OR 
• New appearance of non-pitting/woody edema in an extremity where none was 
previously present, sustained for at least two consecutive evaluations; AND/OR 
• New or worsening edema in a non-extremity site (e.g., periorbital, genital) that 
interferes with function and is sustained for at least two consecutive 
evaluations. 
9.1.6 Recurrent disease 
Recurrent disease is defined as the appearance of tumor following documentation 
of a complete remission. 
9.1.7 Time to response 
Time to response is defined as time from the first dose of chemotherapy until 
documentation of first response. 
9.1.8 Time to progression 
Time to progression is defined as time from initiation of chemotherapy to 
documentation of first progression. 
9.1.9 Response duration 
Response duration is defined as the time from first documentation of response to 
documentation of first progression. 

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10.0 
STATISTICAL CONSIDERATIONS 
10.1 
Study Design/Endpoints 
Primary endpoints 
• Overall response rate 
• Complete response rate 
• Proportion of participants who experience toxicities of Grade 3 or higher 
Secondary endpoints 
• Changes in CD4 counts 
• Changes in HIV viral loads 
10.1.1 Statistical rationale 
The sample size is based on determining if pomalidomide administered as 
monotherapy has sufficient efficacy (overall response rate (ORR) ≥ 30%) to merit 
consideration of further clinical development in this clinical setting, and is 
tolerable. 
10.1.2 Statistical power calculation 
To test the null hypothesis that the ORR = 0.10 against the alternative that it is 0.30 
with pomalidomide monotherapy at the one-sided 0.10 significance level with 
power of 0.90 will require 30 participants. The following stopping rule is based on 
stopping when the probability of observing more than x dose-limiting toxicities 
(DLTs) in the first cycle, as defined in Section 4.2, is less than 0.05 with an 
underlying first cycle DLT rate of 0.10. 
Since the enrollment is planned to close at the end of 2023, the target number of 
enrollment (30 participants) may not be achieved. It is expected that 26 participants 
will be able to be enrolled before study enrollment closes. As an illustration of 
statistical power based on the assumption that the null hypothesis that the ORR = 
10% against the alternative that it is 30% with pomalidomide monotherapy at the 
one-sided 10% significance level, statistical power of 87.5% can be achieved with 
26 participants. The following stopping rule is based on stopping when the 
probability of observing more than x DLTs in the first cycle, as defined in Section 
4.2, is less than 5% with an underlying first cycle DLT rate of 10%. 
10.1.3 Stopping Rules 
Table 10-1. Stopping Rules for Dose-limiting Toxicity 
N 
More Than X Participants with DLTs 
7-8 
2 
9-14 
3 

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15-20 
4 
21-26 
5 
The study team will monitor trial safety and the safety stopping rule using the 
procedures outlined in the DMSP. The AMC Data and Safety Monitoring Board 
(DSMB) will perform an annual review of trial safety to evaluate whether DLTs 
have occurred and that the safety stopping rule has been followed appropriately. 
Accrual will not be paused for these reviews because they are confirmatory to the 
study team’s process, unless the safety rule is invoked by the study team’s review. 
 
 

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Table 10-2. Stopping Rules for Hematologic and Non-Hematologic Toxicity 
 
Stop if the number of cycle 1 ≥ Grade 3 
hematologic toxicities exceeds X OR 
the number of cycle 1 ≥ Grade 3 non-
hematologic toxicities exceeds Y 
N 
X (hem) 
Y (non-hem) 
7 
6 
2 
8 
6 
2 
9 
7 
3 
10 
8 
3 
11 
8 
3 
12 
9 
3 
13 
9 
3 
14 
10 
3 
15 
11 
4 
16 
11 
4 
17 
12 
4 
18 
12 
4 
19 
13 
4 
20 
14 
4 
21 
14 
5 
22 
15 
5 
23 
15 
5 
24 
16 
5 
25 
17 
5 
26 
17 
5 
The stopping rule for hematologic toxicities is based on probability of observing > 
x ≥ Grade 3 hematologic toxicities < 0.05 if the underlying rate of ≥ Grade 3 
hematologic is 0.50. 
The stopping rule for non-hematologic toxicities is based on probability of 
observing > x ≥ Grade 3 non-hematologic toxicities < 0.05 if the underlying rate of 
≥ Grade 3 hematologic is 0.10. 
10.1.4 Statistical analysis plan 
The binomial proportion and its 90% one-sided exact confidence interval will be 

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used to estimate the overall response rate, the complete response rate, and the 
proportion of participants who experience a Grade 3 or higher toxicity. If the lower 
bound of the 90% exact confidence interval for the overall response rate is > 0.10, 
then the null hypothesis will be rejected. 
Changes in CD4 counts and HIV viral load will be evaluated using generalized 
estimating equations. 
To assess the effect of pomalidomide treatment on serum cytokine levels, general 
estimating equations (GEE) will be used to evaluate changes in cytokine levels 
from baseline. Logistic regression analyses will be used to determine if changes in 
cytokine levels from baseline are associated with clinical response. 

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11.0 
ROLE OF DATA MANAGEMENT 
11.1 
CRF Instructions 
Access to the internet data entry system for this study, Advantage eClinical, and 
instructions for recording of study data on CRFs will be provided by the AMC ODMC at 
www.AIDSCancer.org. Participating institutions are responsible for submitting data and/or 
data forms via Advantage eClinical in accordance with the AMC Data Entry Guide and 
specific form instructions, within the timelines specified by the AMC’s Standards of 
Procedure for Site Performance Measures. 
11.2 
Data Quality 
It is the responsibility of the AMC ODMC to assure the quality of data for the study (See 
Appendix III, AMC Data and Safety Monitoring Plan). This role extends from protocol 
development to generation of the final study database. 
11.3 
Data Monitoring 
This study will be monitored in compliance with AMC policies and by the Clinical Data 
Update System (CDUS) Version 3.0. Cumulative protocol- and participant-specific CDUS 
data will be submitted electronically to CTEP on a quarterly basis. Reports are due January 
31, April 30, July 31, and October 31. Instructions for submitting data using the CDUS can 
be found on the CTEP Web site (http://ctep.cancer.gov/reporting/cdus.html). 
The AMC ODMC is responsible for compiling and submitting CDUS data to CTEP for all 
participants and for providing the data to the Principal Investigator for review. 

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12.0 
ETHICAL AND REGULATORY CONSIDERATIONS 
12.1 
IRB Approval and Informed Consent 
The principles of Institutional Review Board (IRB) approval and informed consent 
described in the Department of Health and Human Services (DHHS) regulations for the 
Protection of Human Subjects regulations (45 CFR Part 46) must be followed. The AMC 
will ensure that all participating centers, as required by the applicable regulatory 
requirements in each country in which the trial will be conducted, will submit any required 
applications to the appropriate authorities for review, acceptance, and/or permission to 
begin the trial. Any notification/submission should be dated and contain sufficient 
information to identify the protocol (ICH E6). Documentation of this authorization will be 
collected by the AMC before each center will be activated to enroll participants. 
The sponsor’s designee (AMC ODMC) must receive a copy of the letter of approval from 
the IRB or institutional ethics committee (IEC), which specifically approves the protocol 
and informed consent, before participant enrollment. The IRB/IEC must also approve any 
significant changes to the protocol and documentation of this approval must be sent to the 
AMC ODMC. The IRB/IEC must review the research project at least once every 365 days 
during the duration of the project. Continuing approval of the project must also be given in 
writing and provided to the AMC ODMC. 
Records of all study review and approval documents must be kept on file by the 
Investigator and are participant to inspection during or after completion of the study. AEs 
must be reported to the IRB/IEC according to local procedures. The IRB/IEC should 
receive notification of completion of the study and final report within 3 months of study 
completion and termination. The Investigator will maintain an accurate and complete 
record of all submissions made to the IRB/IEC, including a list of all reports and documents 
submitted. 
Written informed consent will be obtained from the participant. The nature, significance 
and risks associated with the study must be explained to the participant. The informed 
consent will describe the purpose of the study, the procedures to be followed, the risks and 
benefits of participation, all risks of the investigational agent(s) and/or study participation 
as listed in the model informed consent form, and all other elements of informed consent 
as required by regulation. A copy of the consent form will be given to the participant to 
keep. 
In addition, any institution(s) conducting research according to the guidelines of this 
protocol is required to adhere to local and national laws and regulations governing the 
confidentiality and disclosure of health information. 
12.2 
Pomalidomide Counseling Program 
Each site must have two counselors trained by Celgene through the Counseling Program. 
The program is available on the internet for each person who has completed the site 
counselor identification form and registered with Celgene prior to completing the program. 
See Appendix XI for the site counselor identification form. Each participant must be 
counseled prior to dispensing pomalidomide and documentation is kept in the participant’s 
records. Both the training certificates and the completed Pomalidomide Education and 
Counseling Guidance Documents are auditable documents and must be produced upon 

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request. Counselors who wish to counsel participants for different protocols at the same 
site or for the same protocol at different sites should indicate this on the site counselor 
identification form. 
Each site must have two trained counselors available for counseling all participants 
receiving pomalidomide supplied by Celgene. Trained counselors must complete training 
using the online program provided free by Celgene, the pomalidomide counseling program. 
Registration for the program is done by completing the form found in Appendix XI and 
following the directions provided in the email notification. After the training is complete, 
the counselors must generate a training certificate and provide it to the AMC for 
documentation. Sites may not order pomalidomide until documentation for two trained 
counselors is provided to the appropriate office. 
12.3 
Changes to the Protocol 
Any change or addition to this protocol requires a written protocol amendment that must 
be approved by CTEP and the Investigator before implementation. All amendments require 
approval by the IRB/IEC of the treating institution. A copy of the written approval of the 
IRB/IEC and the national regulatory body (if applicable) must be sent to the ODMC. 
12.4 
Women and Minorities 
This study is being conducted by the NCI-sponsored AIDS Malignancy Clinical Trials 
Consortium (AMC). As part of their contractual obligations, each participating site within 
the AMC and the AMC as a whole is required to assure that the participation of women 
and minority participants reflects the percentage representation of these populations in their 
geographic region. As such, it is expected that the representation of participants on this 
trial will reflect the constitution of the respective populations. 
Table 12-1. Accrual Targets 
INTERNATIONAL PLANNED ENROLLMENT REPORT 
Racial Categories 
Ethnic Categories 
Total 
Not Hispanic or 
Latino 
Hispanic or Latino 
Female 
Male 
Female 
Male 
American Indian/ Alaska 
Native 
0 
0 
0 
0 
0 
Asian 
0 
0 
0 
0 
0 
Native Hawaiian or Other 
Pacific Islander 
0 
0 
0 
0 
0 
Black or African American 
2 
24 
0 
0 
26 
White 
0 
0 
0 
0 
0 
More Than One Race 
0 
0 
0 
0 
0 
Total 
2 
24 
0 
0 
26 

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13.0 
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Carlesimo, M., et al. Treatment of Cutaneous and Pulmonary Sarcoidosis with Thalidomide. 
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Castelnuovo, B., et al. Cause-Specific Mortality and the Contribution of Immune Reconstitution 
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Chaulet, C., et al. Design, synthesis and biological evaluation of new thalidomide analogues as 
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Dredge, K., et al. Protective antitumor immunity induced by a costimulatory thalidomide analog 
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Gandhi, A. K., et al. Immunomodulatory agents lenalidomide and pomalidomide co-stimulate T 
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myeloma cells. Science 343 (2014): 301-305 
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in Sub-Saharan Africa. AIDS (London, England) 22.15 (2008): 1897-908. 
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myeloma. Cancer Cell 25 (2014): 9-11 
Lopez-Girona, A., et al. Cereblon is a direct protein target for immunomodulatory and 
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Lu, G., et al. The myeloma drug lenalidomide promotes the cereblon-dependent destruction of 
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Samaniego, F., et al. Vascular Endothelial Growth Factor and Basic Fibroblast Growth Factor 
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of Kaposi's Sarcoma in Resource-Rich and Resource-Limited Settings. Current Opinion in 
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Steff, M., et al. Clinical activity of lenalidomide in visceral human immunodeficiency virus-related 
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Strother, R. M., et al. Retrospective Analysis of the Efficacy of Gemcitabine for Previously Treated 
AIDS-Associated Kaposi's Sarcoma in Western Kenya. Oncology 78.1 (2010): 5-11. 
Xu, W., et al. CC-4047 promotes Th1 cell differentiation and reprograms polarized human Th2 
cells by enhancing transcription factor T-bet. Clinical Immunology 128.3 (2008): 392-399. 
Zachariah, R., et al. Risk Factors for High Early Mortality in Patients on Antiretroviral Treatment 
in a Rural District of Malawi. AIDS (London, England) 20.18 (2006): 2355-60. 
Zhu, Y. X., et al. Cereblon expression is required for the antimyeloma activity of lenalidomide and 
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survival after IMiDs in multiple myeloma. Blood 124 (2014): 536-545. 
 

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APPENDIX I: SCHEDULE OF EVALUATIONS 
The schedule of evaluations below applies to all participants on study. Baseline evaluations are to be conducted within 21 days prior to 
start of protocol therapy, unless otherwise noted. X-rays (and CT scan, if available and clinically indicated) must be done within 21 days 
prior to the start of therapy. Evaluations performed during treatment should be repeated within 3 days prior to initiation of the next cycle 
of therapy, unless otherwise noted. 
Evaluation 
Screening 
Baseline 
C1 
D1 
C2
D1 
C3
D1 
C4
D1 
C5 
D1 
C6 
D1 
C7 
D1 
C8
D1 
C9
D1 
C10 
D1 
C11 
D1 
C12 
D1 
Treatment 
Discontinu
-ationm 
Post-
Treatment 
Follow-upn 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical historya 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Medication historyb 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Physical examc 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Diagnostic biopsyd 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CXR, CT if available and 
indicatede 
X 
 
 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
KS tumor assessment with 
photographic recordf 
Xp 
X 
 
X 
X 
X 
X 
X 
Xo 
X 
X 
X 
X 
X 
X 
X 
KS staging 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CBC w/diff, plateletsh 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Serum chemistriesh,i 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
HIV viral load, CD4 countj 
X 
X 
 
X 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
1 red top tube (7 mL)k 
 
 
X 
 
X 
 
 
 
X 
 
 
 
 
 
X 
 
Pregnancy testing and 
prevention counselingl 
See table below for requirements. 
Dispense pomalidomide 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Drug adherence assessment 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
a:  
To include participant demographic information, and history of AIDS-defining conditions. 
b:  Medication history to adhere to requirements at Section 8.1.3 at baseline, and will be updated at each subsequent visit, including ART adherence assessment. 
c:  
To include vital signs, weight, assessment of signs and symptoms and toxicity, neuropathy evaluation (i.e., pain, aching, or burning in hands or feet), and 
performance status. Height documented at screening only. 

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d:  Biopsy samples must meet requirements for pathology review at Appendix V. 
e:  
Chest X-ray performed at baseline for all participants to evaluate for pulmonary KS. CT of the lung will be performed if available and clinically indicated to 
verify chest X-ray findings. During treatment, chest X-ray (and CT if available/indicated) will be repeated every third cycle for participants with pulmonary 
involvement. At treatment discontinuation, chest C-ray (and CT if available/indicated) will be performed once. 
f:  
Tumor assessment and photographic record may be performed on Day 1 of cycle 1, but no earlier than 7 days before starting treatment. Photographic 
assessments will be repeated on study only following a change in response status. See MOP for details. 
g:  Serum pregnancy test for females of childbearing potential only. See additional chart below for requirements. 
h:  Perform within 7 days before Day 1 of cycle 1. Perform within 3 days before the start of the next cycle for all other cycles. 
i:  
To include sodium, potassium, chloride, bicarbonate, phosphate, glucose, creatinine, albumin, AST, ALT, alkaline phosphatase, and total bilirubin. 
j:  
Collect at all visits indicated. At baseline, collect CD4 count within 28 days before study treatment. At baseline collect HIV viral load within 12 weeks of 
enrollment and within 28 days of the start of protocol therapy. If the HIV viral load test used to determine eligibility is performed within 28 days of start of 
protocol therapy, the test does not need to be repeated. The results of baseline HIV viral load do not need to be available prior to protocol therapy as long as 
eligibility measures are available. At treatment discontinuation, collect both within one week after stopping treatment only. 
k:  For serum cytokine studies (see Appendix XII). Collect prior to treatment at all visits indicated. Collect within 1 week of last dose of protocol treatment. 
l:  
See additional chart below for requirements 
m:  Evaluations to be performed within 1 week after and at 30 days after the last dose of protocol treatment, unless otherwise noted. 
n:  Follow-up evaluations for participants with CR or PR only to occur every 12 weeks ± 2 weeks until week 48 after treatment discontinuation (defined as Day 28 
of the last cycle), unless PD occurs earlier. 
o:  If during the pre-treatment KS assessment on C7D1 the participant has stable disease the participant must discontinue treatment prior to starting cycle 7 of 
therapy. If the participant has partial or complete response, the participant may continue treatment for up to 12 cycles. 
p:  Tumor assessment to determine that participant does not have visceral disease requiring cytotoxic chemotherapy must be performed within 21 days prior to 
enrollment. 

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Celgene Pregnancy Prevention Testing and Counseling Requirements 
Procedure 
Screening 
Cycle 1 
Subsequent 
cycles 
Study drug discontinuation 
≤ 14 days from baseline (first day of study 
drug administration) 
Day 1 
Day 8 
Day 
15 
Day 
22 
Day 1 
Day 
15 
28 days (±7 days) from the 
last of day of last cycle 
Pregnancy testing 1 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
Education 
and 
counseling3 
 
X3 
 
 
 
X3 
 
X3 
Dispense pomalidomide 
 
X4 
 
 
 
X4 
 
 
1Pregnancy tests for females of childbearing potential. A female of childbearing potential (FCBP) is a sexually mature female who: 1) has not undergone a 
hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) 
for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). 
2 Pregnancy tests must occur within 14 days before enrollment and again within 24 hours before initiation of the first cycle of pomalidomide. FCBP with regular 
or no menstruation must have a pregnancy test weekly for the first 28 days and then every 28 days while on study treatment (including breaks in treatment); at 
discontinuation of pomalidomide and at day 28 post the last dose of pomalidomide. Females with irregular menstruation must have a pregnancy test weekly for the 
first 28 days and then every 10-14 days while on study treatment (including breaks in treatment), at discontinuation of pomalidomide and at Day 14 and Day 28 
post the last dose of pomalidomide (see Appendix VII: Pomalidomide Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control 
Methods). 
3 The Pomalidomide Education and Counseling Guidance Document (Appendix VIII) must be completed and signed by a trained counselor at the participating site 
prior to each dispensing of pomalidomide treatment. A copy of this document must be maintained in the participant records. The Pomalidomide Information Sheet 
(Appendix X) will be given to each participant receiving pomalidomide treatment. The participant must read this document prior to starting pomalidomide study 
treatment and each time they receive a new supply of study drug. 
4 Only enough pomalidomide for 21 days or one cycle of study treatment (whichever is shorter) may be provided to the participant each cycle. 

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APPENDIX II: PERFORMANCE STATUS SCALES 
Karnofsky Performance Scale 
ECOG Performance Status Scale 
Percent 
Description 
Grade 
Description 
100 
Normal, no complaints, no 
evidence of disease. 
0 
Normal activity. Fully active, able to 
carry on all pre-disease performance 
without restriction. 
90 
Able to carry on normal activity; 
minor signs or symptoms of 
disease. 
80 
Normal activity with effort; some 
signs or symptoms of disease. 
1 
Symptoms, but ambulatory. 
Restricted in physically strenuous 
activity, but ambulatory and able to 
carry out work of a light or 
sedentary nature (e.g., light 
housework, office work). 
70 
Cares for self, unable to carry on 
normal activity or to do active 
work. 
60 
Requires occasional assistance, 
but is able to care for most of 
his/her needs. 
2 
In bed <50% of the time. 
Ambulatory and capable of all self-
care, but unable to carry out any 
work activities. Up and about more 
than 50% of waking hours. 
50 
Requires considerable assistance 
and frequent medical care. 
40 
Disabled, requires special care and 
assistance. 
3 
In bed >50% of the time. Capable of 
only limited self-care, confined to 
bed or chair more than 50% of 
waking hours. 
30 
Severely disabled, hospitalization 
indicated. Death not imminent. 
20 
Very sick, hospitalization 
indicated. Death not imminent. 
4 
100% bedridden. Completely 
disabled. Cannot carry on any self-
care. Totally confined to bed or 
chair. 
10 
Moribund, fatal processes 
progressing rapidly. 
0 
Dead. 
5 
Dead. 

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APPENDIX III: AMC DATA AND SAFETY MONITORING PLAN 
(Version 9.0 October 6, 2020) 
Introduction 
The AIDS Malignancy Consortium (AMC) Data and Safety Monitoring Plan (DSMP) outlines the 
measures employed by the group to monitor the safety of participants and ensure the data validity 
and integrity for all clinical trials it conducts. This includes methods to: 1) monitor the progress of 
trials and the safety of participants; 2) comply with regulatory requirements for adverse event (AE) 
reporting; 3) processes for trial termination or temporary suspension and major modifications; and 
4) plans for ensuring data accuracy and protocol compliance. As the AMC conducts protocols of 
varying research phase, region of conduct (which may include trials conducted in the U.S., 
international sites, or both), IND Sponsor (AMC Investigator, CTEP, or industry-sponsored) and 
clinical data entry system use, this plan addresses broad processes applying to the range of trial 
designs and requirements. Refer to the individual AMC protocol to identify the applicable study 
characteristics for the relevant requirements described in this plan. 
Monitoring the Progress of Trials and the Safety of Participants 
Routine and Expedited AE reporting 
All AMC protocols that collect safety data adhere to the National Cancer Institute (NCI), Cancer 
Therapy Evaluation Program (CTEP) Guidelines: Adverse Event Reporting Requirements 
(https://ctep.cancer.gov/protocolDevelopment/adverse_effects.htm), as applicable to the clinical 
protocol. AEs are to be recorded in the source documents, assessed by a CI for the AE reporting 
criteria, and promptly reported in the clinical data entry system as required by each protocol. For 
AMC trials conducted under a CTEP IND and AMC trials conducted within the U.S.US, all AEs 
that meet the NCI’s expedited reporting requirements are reported to the NCI via the CTEP 
Adverse Event Reporting System (CTEP-AERS) web application, either directly or through 
integration with Medidata Rave where this system is employed for AMC protocols. Use of this 
system ensures notification to the protocol chair and Investigational Drug Branch (IDB) at CTEP, 
as required for trials conducted under a CTEP IND, and a uniform expedited reporting and safety 
review process for AMC domestic trials. The system may also be programmed to include Sponsor 
notification as required for trials with industry support. Alternate process for expedited AE 
reporting to the AMC protocol chairs and AMC Operations and Data Management Center 
(ODMC) within the clinical data entry system (AdvantageEDC or Advantage eClinical only) may 
be defined in the protocol for select trials (international studies and The ANCHOR Study). 
All serious adverse events (SAEs) received by the AMC ODMC will be reviewed by the AMC 
medical monitor at the AMC ODMC for consideration of individual participant safety, safe trial 
conduct, data reporting quality for AE term selection, and appropriate application of the regulatory 
criteria for seriousness, expectedness, and relatedness to the investigational therapy. If alternate 
procedures are followed for SAE review, the process for adequate medical monitoring will be 
defined in the AMC protocol and the Transfer of Regulatory Obligations (TORO) with the 
Sponsor. AMC medical monitor review includes review of the CTEP-AERS report before CTEP 
submission for IDB review (if applicable), or review of the SAE report in the data entry system 
for trials not using CTEP-AERS for expedited reporting. The IND Sponsor or its designee will 

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issue the determination as to whether the AE requires IND safety reporting to FDA as a serious 
and unexpected suspected adverse drug reaction (SUSAR). For protocols not conducted under an 
IND, in the event of disagreement between the reporting physician and the AMC medical monitor 
regarding the relationship of the AE to the investigational agent(s) (i.e., determination of whether 
the attribution is unrelated or unlikely, or possible, probable, or definite), the AMC medical 
monitor will provide the final determination of the relationship. IND safety reporting to FDA is 
performed by CTEP for trials conducted under a CTEP IND; IND safety reporting is performed 
by the Sponsor or Sponsor’s designee (AMC ODMC or other party defined in the study agreement 
or TORO) for IND studies sponsored by AMC Investigators or industry sponsors. 
Expedited Reporting to the Institutional Review Board (IRB) 
The requirements for IRB review will be identified in the protocol section on ethical and regulatory 
obligations. All AMC trials initiated before September 1, 2020 and all international sites for all 
AMC studies are subject to local IRB review; only U.S.US sites are subject to the NCI requirement 
to use a single IRB for protocols initiated on or after September 1, 2020. For trials subject to local 
IRB review, the site principal Investigator is responsible for ensuring that expedited AE reports 
for its trial participants and any unanticipated problems that affect the local institution only are 
submitted to the local IRB of the reporting institution, per the local IRB’s requirements for such 
reporting. For studies reviewed by the single IRB, the protocol chair will render a determination 
as to whether a SAE or other problem constitutes a trial-wide unanticipated problem that requires 
reporting to that IRB, in accordance with its standards of procedure. 
To comply with Investigator notification requirements for IND studies under 21 CFR 312.32 and 
312.55, IND safety reports from all trials the AMC conducts and reports from external sponsors 
investigating the same agents are made available to all Investigators upon receipt from the Sponsor 
or its designee, either via the password-protected section of the AMC Operations web site (AMC 
trials subject to local IRB review only) or the CTSU website (U.S.US trials subject to single IRB 
review/CTEP IND agents). The site CI responsible for the applicable AMC protocol(s) is 
responsible for reviewing any IND safety reports received and documenting submission to the IRB 
of record (if required by local policy) within the timeline defined by the Clinical Trials Monitoring 
Branch (CTMB) audit guidelines. 
Procedures for Monitoring Trial Progress and Pharmacovigilance 
For trials using AdvantageEDC or Advantage eClinical for clinical data entry, the AMC ODMC 
provides on demand tabular listings of all reported AEs and SAEs on a participant level to the 
protocol chair and co-chair(s) for review via the password-protected section of the AMC 
Operations web site, www.AIDScancer.org. For trials using OPEN and Medidata Rave for clinical 
data collection, data listing will be made available using that system. Summary reports of AEs by 
frequency and relationship to the investigational agent(s) are provided to all AMC Investigators 
and their staff. It is the responsibility of each site to provide trial-specific AE listings to their 
respective IRB, if required by its policies. For blinded studies, the AE and SAE listings are 
reviewed and tabulated without treatment assignment. 
Accrual summaries for each AMC trial are updated nightly on the password-protected section of 
the AMC web site. The progress of each AMC trial is reviewed regularly by the protocol chair and 

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also by the appropriate Scientific Working Group (SWG) during scheduled conference calls 
(monthly SWG calls and as required, protocol-specific monitoring conference calls). Summary 
accrual, summary AE, and individual SAE reports are provided to SWG leadership and protocol 
chairs to monitor participant safety during these monthly calls. 
The AMC medical monitor reviews listings of all reported AEs on a quarterly basis for assuring 
compliance with the protocol requirements for AE reporting and the identification of any safety 
concerns (individual AE or increased frequency/severity of expected AEs) for the agents under 
investigation. Findings from these reviews are communicated to the protocol chairs and all AMC 
Investigators, and posted to the AMC Operations web site. 
Data and Safety Monitoring Board Review (DSMB) Review 
The AMC has formed an independent Data and Safety Monitoring Board (DSMB) for AMC trials 
and for the ANCHOR Study. As required by NCI policy, the AMC requires DSMB review for all 
Phase III randomized trials. All other clinical trials that the AMC initiates will be reviewed by the 
AMC ODMC and AMC Statistical Center during protocol development to issue a recommendation 
as to whether the study requires DSMB oversight, which will require the approval of the AMC 
Executive Committee. This determination will be based on the phase of the study, experimental 
design, risk posed by the investigational approach, extent of data available on the safety of an 
investigational agent, risk posed by the natural course of the health condition under research, and 
the categories of vulnerable populations involved. The involvement of a DSMB in reviewing an 
AMC protocol will be identified in each clinical protocol as approved by CTEP and, as applicable, 
required by the IRB of record. 
Regarding the composition of the AMC DSMB, voting members usually include physicians, 
statisticians, an ethicist, and a patient advocate. All voting members have no other affiliation to 
the AMC and are appointed by the AMC Executive Committee with the approval of the OHAM 
Director. Nonvoting members are the AMC group statistician, the protocol statistician, an AMC 
ODMC staff member, two representatives (normally a clinician or statistician) from CTEP, and 
the grant program directors from the NCI Office of HIV and AIDS Malignancy (OHAM). 
The DSMB reviews all applicable AMC studies in accordance with the National Cancer Institute’s 
Policy for Data and Safety Monitoring. Confidential reports of all trials under review are prepared 
by the AMC group statistician with support from the AMC ODMC. A written report containing 
the current status of each trial monitored, and when appropriate, any toxicity and outcome data, 
are sent to DSMB members by the AMC ODMC within the timelines specified by the DSMB 
charter. This report addresses specific toxicity issues and any other concerns about the conduct of 
the trial, as defined by the protocol plan for DSMB review. The report may contain information 
for the DSMB to render determinations for participant safety, early trial termination, results 
reporting, or continuing accrual or follow-up. 
The results of each DSMB meeting are summarized in a formal report sent by the DSMB chair to 
the AMC group chair and AMC ODMC. The DSMB report contains recommendations on whether 
to close each study reviewed, whether to report the results, and whether to continue accrual or 
follow-up. A primary recommendation (e.g., continue with no change; recommended or required 
modification; stop) must be included in the document. The group chair or designee is then 

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responsible for notifying the protocol chair and relevant SWG chair before the recommendations 
of the DSMB are carried out. In the unlikely event that the protocol chair does not concur with the 
DSMB, then the OHAM program directors and the NCI division director or designee must be 
informed of the reason for the disagreement. The protocol chair, relevant SWG chair, group chair, 
DSMB chair, and NCI division director or designee will be responsible for reaching a mutually 
acceptable decision about the study. CTEP approval of a protocol amendment will be required 
prior to any implementation of a change to the study. 
Following a DSMB meeting, the DSMB’s recommendations are provided to all AMC Investigators 
and staff. It is each site principal Investigator’s responsibility for conveying this information to its 
local IRB as relevant for its protocol participation. For trials reviewed by a single IRB, the AMC 
ODMC will support notification to the IRB as required per its procedures. 
Cohort Trial Reviews Not Subject to DSMB Review 
For Phase I dose escalation trials, dose escalation (or dose de-escalation) is based on the rules in 
the protocol and the protocol chair, AMC medical monitor, and protocol statistician determine 
whether these criteria have been met based on a review of all safety data for the protocol-defined 
evaluation period. If applicable for Phase II trials, stopping the trial for toxicity or efficacy, or 
suspending enrollment pending observation of responses in a multi-stage Phase II trial, is based 
on meeting criteria stated in the protocol, and the protocol chair, AMC medical monitor, and 
protocol statistician determine whether these criteria have been met. 
Plans for Assuring Compliance with Requirements Regarding AE Reporting 
The protocol chair, AMC group chair, and the AMC ODMC share responsibility in assuring that 
participating Investigators comply with applicable regulatory and protocol requirements for AE 
reporting. The AMC site principal Investigator certifies compliance with NCI and FDA 
requirements for trial conduct by signing the site subaward agreement for the grant and the AMC 
Adherence Statement for site membership; clinical Investigators also certify compliance in 
completing the protocol signature page for each protocol active at the site, and Form FDA-1572 
for CTEP Investigator registration, and also for AMC IND studies sponsored by AMC 
Investigators or industry sponsors. Protocol compliance with AE identification, assessment and 
reporting requirements is assessed by the AMC ODMC using several methods: 1) programmed 
system checks and messages to instruct the site to complete routine and/or expedited reporting 
when certain criteria are reported in the clinical data entry system; 2) programmed data reports 
provided to the protocol chairs that identify reports requiring expedited AE reporting; 3) remote 
review of data entry or data reports to ensure compliance with protocol and NCI AE reporting 
requirements; 4) AMC medical monitor review described in the section above; and, 5) routine site 
audits by reviewing the site’s source documentation. 
The clinical data entry systems used for AMC studies include the Oncology Patient Enrollment 
Network, OPEN for enrollment, and Medidata Rave for clinical data entry for enrolled 
participants; trials activated before September 1, 2020 or that involve only AMC international sites 
may be reported in AdvantageEDC/Advantage eClinical, a web-based data entry and enrollment 
system. These data entry systems are programmed to notify the site Investigator, protocol chair, 
AMC medical monitor, and AMC ODMC via email in the event that a site reports an AE that 

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meets expedited reporting criteria to NCI and/or FDA. Additional reporting conditions may be 
programmed depending on the Sponsor reporting requirements of a given protocol (e.g., adverse 
events of special interest [AESI]). If the site does not follow with an expedited report, the AMC 
ODMC contacts sites to request compliance with reporting requirements. Additionally, the 
protocol chair, AMC ODMC, and the AMC medical monitor review reported AEs on a routine 
basis to identify AEs reported by sites that require expedited reporting. The protocol chair, AMC 
SWG chairs, AMC group chair, and IND sponsors have general oversight for assuring that routine 
and expedited adverse reporting requirements are met by the responsible parties. 
For studies monitored by CTEP using the Data Mapping Utility (DMU), cumulative protocol- and 
patient-specific data will be submitted weekly to CTEP electronically via the DMU. For trials 
monitored by the NCI’s Clinical Data Update System (CDUS), AE information is transmitted 
electronically to NCI on a quarterly basis. For trials monitored by NCI’s Clinical Trials Monitoring 
Service (CTMS), AE information is transmitted electronically to NCI every two weeks. 
Plans for Assuring that any Action Resulting in a Temporary or Permanent Suspension of 
an NCI-Funded Clinical Trial is Reported to the NCI Grant Program Director Responsible 
for the Grant 
In the event that temporary or permanent suspension of a trial, or major modification to the 
protocol is under consideration, the protocol chair will convene the AMC ODMC, AMC Statistical 
Center, and SWG chair by conference call to discuss the options. Suspension actions will also be 
reviewed by the AMC Executive Committee for program oversight and direct communication of 
the action with the OHAM program directors. For Phase III trials, closure decisions are typically 
rendered by the AMC DSMB; if the trial in question is under AMC DSMB oversight but rendered 
by the AMC Investigators, the AMC DSMB will be notified of the suspension and the reason. For 
Phase I and II trials, the protocol chair also has the option of asking the DSMB to review the study. 
The AMC ODMC will inform the CTEP Protocol Information Office (PIO), with copy to OHAM 
Directors, when studies are temporarily or permanently closed. In the event of major trial 
modification, CTEP must approve all protocol amendments prior to distributing to the AMC sites. 
Plans for Assuring Data Accuracy and Protocol Compliance 
All study data for AMC clinical trials are entered directly by AMC clinical site staff into the 
applicable clinical data entry system for the trial. During data entry, the system performs validation 
checks on many fields and performs consistency checks between select fields. Range checks are 
placed on each field to eliminate entry of out-of-range values. Edit check programs are run on the 
database on a set schedule to identify and resolve inconsistencies between forms or data collected 
at different points in time. Submitted data entry forms are reviewed for compliance with the 
protocol and data entry instructions according to the AMC ODMC’s standards for data quality 
processes. AMC ODMC staff routinely interacts with site staff to resolve any data submission 
problems. 
In accordance with NCI guidelines, the AMC ODMC conducts audits at the AMC sites to evaluate 
compliance with regulatory issues, and to review data for specific cases by checking source 
documents. These reports are sent to the site Principal Investigator and to the NCI. In the event 
that major violations are identified, sites are asked to provide a written corrective and preventative 

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action plan to correct deficiencies. If needed, a repeat site audit is conducted. In the event that a 
site does not correct deficiencies in a pre-determined time frame, the AMC Executive Committee 
has the option to implement remedial action(s) for the site. Possible actions include, but are not 
limited to, suspending enrollment of new patients to AMC trials until deficiencies are corrected; 
recommending a decrease in funding to the site; and requiring specific training for site 
Investigators or staff members. 

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APPENDIX IV: PARTICIPANT MEDICATION DIARY 
YOU MUST KEEP THIS DIARY AND BRING IT TO EVERY APPOINTMENT. 
Study Participant ID #: _______________ 
Cycle # ____ 
Pomalidomide dose: ____ mg (_______ 4 mg capsules and ____ 3 mg capsules) daily x 21 days 
(no drug on days 22-28) 
Please record in the chart below the date and time that your pomalidomide dose was taken. Be sure 
to record the doses when you take them, and avoid writing entries for several days at once. When 
you are finished, bring this diary with you when you next see the Doctor or Study Staff. In the 
“Comments” section write any problems you are having with the medicines or if you missed a 
dose and why or if you only took part of the medicine. 
Your pomalidomide capsules should be taken by mouth once a day around the same time each 
day, with or without food. Capsules should be swallowed whole and taken with water and not 
crushed, chewed or opened. DO NOT to bite or chew on the capsule. Drink an extra glass of water 
immediately if the capsule breaks in your mouth. 
Missed pomalidomide doses, regardless of reason, SHOULD be taken within 12 hours of when it 
would normally be taken. If more than 12 hours have passed, the dose SHOULD NOT be taken. 
If you skip a dose, the missed dose SHOULD NOT be made up. If you accidentally take more than 
the prescribed dose of pomalidomide contact the study staff immediately and seek emergency 
medical care if needed. 
Pomalidomide SHOULD NOT be handled by non-patient FCBP or non-patient partners of FCBP 
unless gloves are worn. If any contact with a broken pomalidomide capsule or the medicine in the 
capsule occurs, the exposed area should be washed immediately and thoroughly with soap and 
water. 
Day of 
Cycle 
Date 
DD/MMM/YYYY 
Time 
Pomalidomide 
Taken 
(circle AM/PM) 
# of 4mg 
Capsules 
Taken 
# of 3mg 
Capsules 
Taken 
Comments 
1 
_____/_________/______ 
___:___ AM / PM 
 
 
 
2 
_____/_________/______ 
___:___ AM / PM 
 
 
 
3 
_____/_________/______ 
___:___ AM / PM 
 
 
 
4 
_____/_________/______ 
___:___ AM / PM 
 
 
 
5 
_____/_________/______ 
___:___ AM / PM 
 
 
 
6 
_____/_________/______ 
___:___ AM / PM 
 
 
 
7 
_____/_________/______ 
___:___ AM / PM 
 
 
 

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Study Participant ID #: _______________ 
Cycle # ____ 
Day of 
Cycle 
Date 
MM/DD/YYYY 
Time 
Pomalidomide 
Taken 
(circle AM/PM) 
# of 4mg 
Capsules 
Taken 
# of 3mg 
Capsules 
Taken 
Comments 
8 
_____/_________/______ 
___:___ AM / PM 
 
 
 
9 
_____/_________/______ 
___:___ AM / PM 
 
 
 
10 
_____/_________/______ 
___:___ AM / PM 
 
 
 
11 
_____/_________/______ 
___:___ AM / PM 
 
 
 
12 
_____/_________/______ 
___:___ AM / PM 
 
 
 
13 
_____/_________/______ 
___:___ AM / PM 
 
 
 
14 
_____/_________/______ 
___:___ AM / PM 
 
 
 
15 
_____/_________/______ 
___:___ AM / PM 
 
 
 
16 
_____/_________/______ 
___:___ AM / PM 
 
 
 
17 
_____/_________/______ 
___:___ AM / PM 
 
 
 
18 
_____/_________/______ 
___:___ AM / PM 
 
 
 
19 
_____/_________/______ 
___:___ AM / PM 
 
 
 
20 
_____/_________/______ 
___:___ AM / PM 
 
 
 
21 
_____/_________/______ 
___:___ AM / PM 
 
 
 
Please return the unused capsules to your doctor with your diary at your next appointment. 
 
Participant’s signature: ________________________________ 
Date of signature: _____________________________________ 
 
Study Staff Must Complete This Section: 
1. 
Date of last study visit ______________________________________ 
2. 
Date of current visit ______________________________________ 
3. 
Participant’s planned total daily dose during that period __________________________ 

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4. 
Total number of capsules during that period 
_____________________________________ 
5. 
Total number of capsules 
returned______________________________________________ 
6. 
Study Staff Signature ____________________________________ 
NOTE: Non-compliance with study agent administration should be noted at the time of diary 
collection and the participant should be instructed again regarding dosing instructions. 

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APPENDIX V: CENTRAL PATHOLOGY REVIEW 
 
Handling of Tissues: 
Participants must have measurable cutaneous Kaposi sarcoma (KS) that has been pathologically 
confirmed by an AMC-approved pathologist. Participants must have one of the following for the 
purposes of external pathology review: 
• Diagnostic tissue block or H&E plus five blank FFPE sections for LANA staining at the AMC 
Sub Saharan Biorepository, or 
• High quality images of the LANA staining for electronic submission for pathology review and 
H&E is available on site 
Tissues should be submitted to the AMC sub-Saharan Biorepository for storage, according to the 
specimen handling requirements and shipping schedules specified in the AMC-100 Manual of 
Procedures. 
Record of Specimens: 
This study will track specimens via GlobalTraceSM, a component of the AMC Advantage eClinical 
system. The GlobalTrace shipment manifest must accompany all specimen shipments. 
Pathology Review: 
Pathology review will be conducted under the supervision of Dr. Ethel Cesarman of Weill-Cornell 
Medical College, at the AMC Pathology Core Laboratory. 

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APPENDIX VI: LIST OF PROHIBITED AND CAUTIONARY MEDICATIONS 
The following medications may not be taken while participating on this study through 30 days 
after the last dose of protocol treatment: 
Use of agents containing zidovudine (including Combivir® and Trizivir®) are prohibited. In order 
to be eligible, participants taking zidovudine must change to a different regimen at least 7 days 
prior to therapy initiation. Changes to ART therapy during the study may be made if medically 
necessary (toxicity, failure of regimen, etc.). 
Use of medications or substances that are strong inhibitors of CYP1A2, which include amiodarone, 
cimetidine, fluoroquinolones (e.g., ciprofloxacin, enoxacin), fluvoxamine; and ticlopidine are 
excluded. 
Co-administration of efavirenz, an inhibitor of CYP1A2, with strong inhibitors of CYP3A4 and 
P-glycoprotein (P-gp) is prohibited. 
Use of erythropoietin is prohibited. 
Because there is a potential for interaction of pomalidomide with other concomitantly administered 
drugs through the cytochrome P450 system, the case report form must capture the concurrent use 
of all other drugs, over-the-counter medications, or alternative therapies. The Principal 
Investigator should be alerted if the participant is taking any agent known to affect or with the 
potential to affect selected CYP450 isoenzymes. Due to known cytochrome P450 inhibitory effects 
of protease inhibitors, particularly for ritonavir, the case report form will particularly note the use 
of ritonavir for HIV management. 
Because the lists of these agents are constantly changing, it is important to regularly consult 
frequently updated medical references. 

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APPENDIX VII: POMALIDOMIDE RISKS OF FETAL EXPOSURE, PREGNANCY 
TESTING GUIDELINES AND ACCEPTABLE BIRTH CONTROL METHODS 
Risks associated with pregnancy 
Pomalidomide was teratogenic in both rats and rabbits when administered during the period of 
organogenesis. Pomalidomide is an analogue of thalidomide. Thalidomide is a known human 
teratogen that causes severe life-threatening human birth defects. If pomalidomide is taken during 
pregnancy, it can cause birth defects or death to an unborn baby. 
The teratogenic effect of pomalidomide in humans cannot be ruled out. Therefore, a pregnancy 
prevention program must be followed. 
Definition of females of childbearing potential (FCBP) 
A FCBP is a female who: 1) has achieved menarche at some point, 2) has not undergone a 
hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea 
following cancer therapy does not rule out childbearing potential) for at least 24 consecutive 
months (i.e., has had menses at any time in the preceding 24 consecutive months). 
Definition of females not of childbearing potential 
Females who do not meet the above definition of FCBP should be classified as FNCBP. 
Counseling 
For a FCBP, pomalidomide is contraindicated unless all of the following are met (i.e., all FCBP 
must be counseled concerning the following risks and requirements prior to the start of 
pomalidomide): 
• She understands the potential teratogenic risk to the unborn child. 
• She understands the need for effective contraception, without interruption, 28 days before 
starting pomalidomide, throughout the entire duration of pomalidomide, during dose 
interruptions and for at least 28 days after the last dose of pomalidomide. 
• She understands and agrees to inform the Investigator if a change or stop of method of 
contraception is needed. 
• She must be capable of complying with effective contraceptive measures. 
• She is informed and understands the potential consequences of pregnancy and the need to 
notify her study doctor immediately if there is a risk of pregnancy. 
• She understands the need to commence pomalidomide as soon as it is dispensed following a 
negative pregnancy test. 
• She understands and accepts the need to undergo pregnancy testing based on the frequency 
outlined in this plan and in the Informed Consent. 
• She acknowledges that she understands the hazards pomalidomide can cause to an unborn fetus 
and the necessary precautions associated with the use of pomalidomide. 
The investigator must ensure that a FCBP: 
• Complies with the conditions of the pregnancy prevention plan, including confirmation that 
she has an adequate level of understanding. 
• Acknowledges the aforementioned requirements. 

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Females NOT of childbearing potential 
For a FNCBP, pomalidomide is contraindicated unless all of the following are met (i.e., all FNCBP 
must be counseled concerning the following risks and requirements prior to the start of 
pomalidomide): 
• She acknowledges she understands the hazards pomalidomide can cause to an unborn fetus 
and the necessary precautions associated with the use of pomalidomide. 
Males 
The effect of pomalidomide on sperm development is not known and has not been studied. The 
risk to an unborn baby in females of childbearing potential whose male partner is receiving 
pomalidomide is unknown at this time. Therefore, male participants taking pomalidomide must 
meet the following conditions (i.e., all males must be counseled concerning the following risks 
and requirements prior to the start of pomalidomide): 
• Understand the potential teratogenic risk if engaged in sexual activity with a pregnant female 
or a FCBP. 
• Understand the need for the use of a condom even if he has had a vasectomy, if engaged in 
sexual activity with a pregnant female or a FCBP. 
• Understand the potential teratogenic risk if the participant donates semen or sperm. 
Contraception 
Female participants of childbearing potential 
Females of childbearing potential enrolled in this protocol must agree to use two reliable forms of 
contraception simultaneously or to practice complete abstinence (true abstinence is acceptable 
when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence 
[e.g. calendar, ovulation, symptothermal or post-ovulation methods] and withdrawal are not 
acceptable methods of contraception) from heterosexual contact during the following time periods 
related to this study: 
1. For at least 28 days before starting pomalidomide; 
2. While taking pomalidomide; 
3. Dose interruptions; and 
4. For at least 28 days after the last dose of pomalidomide. 
The two methods of reliable contraception must include one highly effective method and one 
additional effective (barrier) method. If the below contraception methods are not appropriate for 
the FCBP, she must be referred to a qualified provider of contraception methods to determine the 
medically effective contraceptive method appropriate to the participant. The following are 
examples of highly effective and additional effective methods of contraception: 
• Examples of highly effective methods: 
o Intrauterine device (IUD) 
o Hormonal (birth control pills, injections, implants, levonorgetrel-releasing intrauterine 
system [IUS], medroxyprogeterone acetate depot injections, ovulation inhibitor 
progesterone-only pills [e.g. desogestrel]) 
o Tubal ligation 
o Partner’s vasectomy 

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* For purposes of this study, birth control pills and partner’s vasectomy will not be 
considered highly effective methods of contraception. 
• Examples of additional effective methods: 
o Male condom 
o Diaphragm 
o Cervical Cap 
Because of the increased risk of venous thromboembolism in participants with multiple myeloma 
taking pomalidomide and dexamethasone, combined oral contraceptive pills are not 
recommended. If a participant is currently using combined oral contraception the participant 
should switch to another one of the highly effective methods listed above. The risk of venous 
thromboembolism continues for 4 to 6 weeks after discontinuing combined oral contraception. The 
efficacy of contraceptive steroids may be reduced during co-treatment with dexamethasone. 
Implants and levonorgestrel-releasing intrauterine systems are associated with an increased risk of 
infection at the time of insertion and irregular vaginal bleeding. Prophylactic antibiotics should be 
considered particularly in participants with neutropenia. 
Male participants 
Male participants must practice complete abstinence (True abstinence is acceptable when this is in 
line with the preferred and usual lifestyle of the participant. Periodic abstinence [eg calendar, 
ovulation, symptothermal or post-ovulation methods] and withdrawal are not acceptable methods 
of contraception.) or agree to use a condom during sexual contact with a pregnant female or a 
FCBP while taking pomalidomide, during dose interruptions and for at least 28 days after the last 
dose of pomalidomide, even if he has undergone a successful vasectomy. 
Pregnancy testing 
Medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/mL must be 
performed for FCBP. 
Females of Childbearing Potential must have two negative pregnancy tests (sensitivity of at least 
25 mIU/mL) prior to starting pomalidomide. The first pregnancy test must be performed within 14 
days prior to the start of pomalidomide and the second pregnancy test must be performed within 
24 hours prior to the start of pomalidomide. The participant may not receive pomalidomide until 
the study doctor has verified that the results of these pregnancy tests are negative. 
Females of childbearing potential with regular or no menstrual cycles must agree to have 
pregnancy tests weekly for the first 28 days of study participation and then every 28 days while 
taking pomalidomide, at study discontinuation, and at Day 28 following the last dose of 
pomalidomide. 
Females of childbearing potential with irregular menstrual cycles must agree to have pregnancy 
tests weekly for the first 28 days of study participation and then every 14 days while taking 
pomalidomide, at study discontinuation, and at Days 14 and 28 following the last dose of 
pomalidomide. 
Regular menses are defined as a 28-day (+/- 7 days) cycle. 
A participant’s menses are considered irregular if the cycle length is less than 21 days or greater 
than 35 days. If a participant is unable to recall the date of her last menstrual period, the irregular 
menses pregnancy testing schedule must be followed. 

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Pregnancy Precautions for Pomalidomide Use 
Before Starting Pomalidomide 
Female participants of childbearing potential 
Females of childbearing potential must have two negative pregnancy tests (sensitivity of at least 
25 mIU/mL) prior to starting pomalidomide. The first pregnancy test must be performed within 14 
days prior to the start of pomalidomide and the second pregnancy test must be performed within 
24 hours prior to the start of pomalidomide. The participant may not receive pomalidomide until 
the study doctor has verified that the results of these pregnancy tests are negative. 
Females of childbearing potential must use two reliable forms of contraception simultaneously, or 
practice complete abstinence (True abstinence is acceptable when this is in line with the preferred 
and usual lifestyle of the participant. Periodic abstinence [e.g., calendar, ovulation, symptothermal 
or post-ovulation methods] and withdrawal are not acceptable methods of contraception.) from 
heterosexual contact for at least 28 days before starting pomalidomide. 
Male participants 
Male participants must agree to practice complete abstinence (True abstinence is acceptable when 
this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence [e.g., 
calendar, ovulation, symptothermal or post-ovulation methods] and withdrawal are not acceptable 
methods of contraception.) or agree to use a condom during sexual contact with a pregnant female 
or a FCBP while taking pomalidomide, during dose interruptions and for at least 28 days after the 
last dose of pomalidomide, even if he has undergone a successful vasectomy. 
During and After Study Participation 
Female participants 
• Females of childbearing potential with regular or no menstrual cycles must agree to have 
pregnancy tests weekly for the first 28 days of study participation and then every 28 days while 
taking pomalidomide, at study discontinuation, and at Day 28 following the last dose of 
pomalidomide. 
• Females of childbearing potential with irregular menstrual cycles must agree to have 
pregnancy tests weekly for the first 28 days of study participation and then every 14 days while 
taking pomalidomide, at study discontinuation, and at Days 14 and 28 following the last dose 
of pomalidomide. 
• At each visit, the Investigator must confirm with the FCBP that she is continuing to use two 
reliable methods of birth control if not committing to complete abstinence, or confirm 
commitment to complete abstinence. 
• If a FCBP considers the need to change or to stop a method of contraception, the Investigator 
must be notified immediately. 
• Counseling about pregnancy precautions and the potential risks of fetal exposure must be 
conducted at a minimum of every 28 days. 
• If pregnancy or a positive pregnancy test does occur in a participant, pomalidomide must be 
immediately discontinued. 
• Pregnancy testing and counseling must be performed if a participant misses her period or if her 
pregnancy test or her menstrual bleeding is abnormal. Pomalidomide must be discontinued 
during this evaluation. 

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• Females must agree to abstain from breastfeeding while taking pomalidomide and for at least 
28 days after the last dose of pomalidomide. 
Male participants 
• Must practice complete abstinence (True abstinence is acceptable when this is in line with the 
preferred and usual lifestyle of the participant. Periodic abstinence [e.g., calendar, ovulation, 
symptothermal or post-ovulation methods] and withdrawal are not acceptable methods of 
contraception.) or use a condom during sexual contact with a pregnant female or a FCBP while 
receiving pomalidomide, during dose interruptions and for at least 28 days after the last dose 
of pomalidomide, even if he has undergone a successful vasectomy. 
• Must not donate semen or sperm while receiving pomalidomide, during dose interruptions or 
for at least 28 days after the last dose of pomalidomide. 
• Counseling about pregnancy precautions and the potential risks of fetal exposure must be 
conducted at a minimum of every 28 days. 
• If pregnancy or a positive pregnancy test does occur in the partner of a male participant while 
taking pomalidomide, the Investigator must be notified immediately. 
Additional precautions 
• Participants should be instructed to never give pomalidomide to another person. 
• Participants should be instructed to return any unused capsules to the study doctor. 
• Participants should not donate blood while receiving pomalidomide, during dose interruptions 
and for at least 28 days after the last dose of pomalidomide. 
• No more than a 21-day pomalidomide supply may be dispensed with each cycle of 
pomalidomide. 

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APPENDIX VIII: POMALIDOMIDE EDUCATION AND COUNSELING GUIDANCE 
DOCUMENT FOR FEMALE PARTICIPANTS 
To be completed prior to each dispensing of study drug. 
Protocol Number: _______ 
Study Participant ID: ________________ 
(Check the appropriate box to indicate risk category) 
Female 
If female, check one: 
□ 
FCBP (Female of childbearing potential): a female who: 1) has achieved menarche (first 
menstrual cycle) at some point, 2) has not undergone a hysterectomy (the surgical removal 
of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 3) has not 
been naturally postmenopausal (amenorrhea following cancer therapy does not rule out 
childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time 
during the preceding 24 consecutive months) 
□ 
NOT FCBP 
Female of childbearing potential 
1. I have verified and counseled the participant regarding the following: 
• Potential risk of fetal exposure to pomalidomide: A teratogenic potential of pomalidomide 
in humans cannot be ruled out. If pomalidomide is taken during pregnancy, it may cause 
birth defects or death to any unborn baby. Females are advised to avoid pregnancy while 
taking pomalidomide. Females of childbearing potential must agree not to become 
pregnant while taking pomalidomide. 
• That the required pregnancy tests performed are negative. 
• The participant confirmed that she is using TWO reliable methods of birth control at the 
same time or complete abstinence (true abstinence is acceptable when this is in line with 
the preferred and usual lifestyle of the participant. Periodic abstinence [e.g., calendar, 
ovulation, symptothermal or post-ovulation methods] and withdrawal are not acceptable 
methods of contraception) from heterosexual contact (at least 28 days prior to receiving 
pomalidomide, while receiving pomalidomide, during dose interruptions and for at least 
28 days after the last dose of pomalidomide). 
• One highly effective method and one additional method of birth control must be used AT 
THE SAME TIME. The following are examples of highly effective and additional effective 
methods of contraception: 
o Examples of highly effective methods: 
- 
Intrauterine device (IUD) 
- 
Hormonal (birth control pills, injections, implants, levonorgestrel-releasing 
intrauterine system [IUS], medroxyprogesterone acetate depot injections, ovulation 
inhibitory progesterone-only pills [e.g. desogestrel]) 
- 
Tubal ligation 
- 
Partner’s vasectomy 
* For purposes of this study, birth control pills and partner’s vasectomy will not 

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be considered highly effective methods of contraception. 
o Examples of additional effective methods: 
- 
Male condom 
- 
Diaphragm 
- 
Cervical Cap 
• The participant confirmed that even if she has amenorrhea she must comply with advice 
on contraception. 
• Pregnancy tests before, during administration of pomalidomide and at last dose of 
pomalidomide, even if the participant agrees not to have reproductive heterosexual contact. 
• Frequency of pregnancy tests to be done: 
o Two pregnancy tests will be performed prior to receiving pomalidomide, one within 10 
to 14 days and a second within 24 hours of the start of pomalidomide. 
o Every week during the first 28 days of this study and a pregnancy test every 28 days 
while the participant is taking pomalidomide if menstrual cycles are regular 
o Every week during the first 28 days of this study and a pregnancy test every 14 days 
while the participant is taking pomalidomide if menstrual cycles are irregular. 
o If the participant missed a period or has unusual menstrual bleeding. 
o When the participant is discontinued from the study and at day 28 after the last dose of 
pomalidomide if menstrual cycles are regular. If menstrual cycles are irregular, 
pregnancy tests will be done at discontinuation from the study and at days 14 and 28 
after the last dose of pomalidomide. 
• The participant confirmed that she will stop taking pomalidomide immediately in the event 
of becoming pregnant and to call her study doctor as soon as possible. 
• The participant confirmed that she has not and will not breastfeed a baby while taking 
pomalidomide and for at least 28 days after the last dose of pomalidomide. 
• The participant confirmed that she will stop taking pomalidomide immediately in the event 
of becoming pregnant and to call her study doctor as soon as possible. 
• The participant confirmed that she has not and will not breastfeed a baby while taking 
pomalidomide and for at least 28 days after the last dose of pomalidomide. 
• The participant has not and will never share pomalidomide with anyone else. 
• The participant has not and will not donate blood while taking pomalidomide, during dose 
interruptions and for at least 28 days after the last dose of pomalidomide. 
• The participant has not and will not break, chew, or open pomalidomide capsules at any 
point. 
• The participant confirmed that she will return unused pomalidomide capsules to the study 
doctor. 
I have provided the Pomalidomide Information Sheet to the participant. 
Female Not of Childbearing Potential (Natural Menopause for at Least 24 Consecutive Months, 
a Hysterectomy, or Bilateral Oophorectomy) 
I have verified and counseled the participant regarding the following: 
• Potential risk of fetal exposure to pomalidomide: A teratogenic potential of pomalidomide in 
humans cannot be ruled out. If pomalidomide is taken during pregnancy, it may cause birth 
defects or death to any unborn baby. 
• The participant has not and will never share pomalidomide with anyone else. 
• The participant has not and will not donate blood while taking pomalidomide, during dose 

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interruptions and for at least 28 days after the last dose of pomalidomide. 
• The participant has not and will not break, chew, or open pomalidomide capsules at any point. 
• The participant confirmed that she will return unused pomalidomide capsules to the study 
doctor. 
I have provided the Pomalidomide Information Sheet to the participant. 
Do Not Dispense Pomalidomide if: 
• The participant is pregnant. 
• No pregnancy tests were conducted for a FCBP. 
• The participant states she did not use TWO reliable methods of birth control (unless 
practicing complete abstinence from heterosexual contact) at least 28 days prior to 
receiving pomalidomide, while receiving pomalidomide and during dose interruptions. 
• The participant stated that she has or does not want to adhere to pregnancy precautions 
outlined within this Pregnancy Prevention Plan (PPP). 
______________________________________________________________________________ 
 
Counselor Name (Print): ______________________ 
Counselor Signature: _______________________ 
Date: _____/_____/_____ 
 
**Maintain a copy of the Education and Counseling Guidance Document in the patient 
records** 

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APPENDIX IX: POMALIDOMIDE EDUCATION AND COUNSELING GUIDANCE 
DOCUMENT FOR MALE PARTICIPANTS 
To be completed prior to each dispensing of pomalidomide. 
Protocol Number: ____________________________________________ 
Participant Name (Print): __________________ DOB: _____/_____/_____ (dd/mmm/yyyy) 
1. I have verified and counseled the subject regarding the following: 
 Potential risk of fetal exposure to pomalidomide: A teratogenic potential of 
pomalidomide in humans cannot be ruled out. If pomalidomide is taken during 
pregnancy, it may cause birth defects or death to any unborn baby. 
 The participant confirmed that he has practiced complete abstinence (True abstinence 
is acceptable when this is in line with the preferred and usual lifestyle of the subject. 
Periodic abstinence [e.g. calendar, ovulation, symptothermal or post-ovulation 
methods] and withdrawal are not acceptable methods of contraception.) or used a 
condom when engaging in sexual contact (including those who have had a vasectomy) 
with a pregnant female or FCBP, while taking pomalidomide, during dose interruptions 
and for at least 28 days after the last dose of pomalidomide. 
 The participant confirmed that he has not impregnated his female partner while in the 
study. 
 The participant confirmed that he will notify his study doctor if his female partner 
becomes pregnant and the female partner of a male subject taking pomalidomide 
confirmed that she will call her healthcare provider immediately if she becomes 
pregnant. 
 The participant has not and will never share pomalidomide with anyone else. 
 The participant confirmed that he has not donated and will not donate semen or sperm 
while taking pomalidomide or during dose interruptions and that he will not donate 
semen or sperm for at least 28 days after the last dose of pomalidomide. 
 The participant has not and will not donate blood while taking pomalidomide, during 
dose interruptions and for at least 28 days after the last dose of pomalidomide. 
 The participant has not and will not break, chew, or open pomalidomide capsules at 
any point. 
 The participant confirmed that he will return unused pomalidomide capsules to the 
study doctor. 
2. I have provided the Pomalidomide Information Sheet to the participant. 
 
 

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Do Not Dispense Pomalidomide if: 
• The participant stated that he has or does not want to adhere to pregnancy precautions 
outlined within this PPP. 
 
Counselor Name (Print): ____________________  
 
Counselor Signature: _______________________  Date: _____/_____/_____(dd/mmm/yyyy) 
 
**Maintain a copy of the Education and Counseling Guidance Document in the subject’s 
records.** 
 
 

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APPENDIX X: POMALIDOMIDE INFORMATION SHEET FOR PATIENTS 
ENROLLED IN CLINICAL RESEARCH STUDIES 
Please read this Pomalidomide Information Sheet before you start taking pomalidomide and each 
time you get a new supply. This Pomalidomide Information Sheet does not take the place of an 
informed consent to participate in clinical research or talking to your study doctor or healthcare 
provider about your medical condition or your treatment. 
What is the most important information I should know about pomalidomide? 
1. Pomalidomide may cause birth defects (deformed babies) or death of an unborn baby. 
Pomalidomide is similar to the medicine thalidomide. It is known that thalidomide causes life-
threatening birth defects. Pomalidomide has not been tested in pregnant women but may also 
cause birth defects. Pomalidomide was found to cause birth defects when tested in pregnant 
rats and rabbits. If you are a female who is able to become pregnant: 
• Do not take pomalidomide if you are pregnant or plan to become pregnant 
• You must practice complete abstinence from sexual contact with a male or use two 
reliable, separate forms of effective birth control at the same time: 
o for 28 days before starting pomalidomide 
o while taking pomalidomide 
o during breaks (dose interruptions) of pomalidomide 
o for at least 28 days after stopping pomalidomide 
• You must have pregnancy testing done at the following times: 
o within 10 to 14 days prior to the first dose of pomalidomide 
o 24 hours prior to the first dose of pomalidomide 
o weekly for the first 28 days 
o if you have regular menstrual periods: every 28 days after the first month 
o if you have irregular menstrual periods: every 14 days after the first month 
o if you miss your period or have unusual menstrual bleeding 
o 28 days after the last dose of pomalidomide (14 and 28 days after the last dose if 
menstrual periods are irregular) 
• Stop taking pomalidomide if you become pregnant while taking pomalidomide 
o If you suspect you are pregnant at any time during the study, you must stop 
pomalidomide immediately and immediately inform your study doctor. Your study 
doctor will report all cases of pregnancy to the National Cancer Institute who will report 
the case to the pharmaceutical collaborator Celgene Corporation. 
• Do not breastfeed while taking pomalidomide and for at least 28 days after the last 
dose of pomalidomide 
o The study doctor will be able to advise you where to get additional advice on 
contraception. 
If you are a female not able to become pregnant 
In order to ensure that an unborn baby is not exposed to pomalidomide, your study doctor will 
confirm that you are not able to become pregnant. 

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If you are a male 
The effect of pomalidomide on sperm development is not known and has not been studied. The 
risk to an unborn baby in females whose male partner is receiving pomalidomide is unknown 
at this time. 
1. Male participants (including those who have had a vasectomy) must practice complete 
abstinence or must use a condom during sexual contact with a pregnant female or a female 
that can become pregnant: 
• While you are taking pomalidomide 
• During breaks (dose interruptions) of pomalidomide 
• For at least 28 days after the last dose of pomalidomide 
2. Male participants should not donate sperm or semen while taking pomalidomide, 
during breaks (dose interruptions) and for at least 28 days after the last dose of 
pomalidomide. 
3. If you suspect that your partner is pregnant any time during the study, you must 
immediately inform your study doctor. The study doctor will report all cases of 
pregnancy to the National Cancer Institute who will report the cases to the 
pharmaceutical collaborator, Celgene Corporation. Your partner should call their 
healthcare provider immediately if they become pregnant. 
All participants 
1. Do not share pomalidomide with other people. It must be kept out of the reach of 
children and should never be given to any other person. 
2. Do not donate blood while you take pomalidomide, during breaks (dose interruptions) and 
for at least 28 days after the last dose of pomalidomide. 
3. Do not break, chew, or open pomalidomide capsules at any point. 
4. You will get no more than a 28-day supply of pomalidomide at one time. 
5. Return unused pomalidomide capsules to your study doctor. 
Additional information is provided in the informed consent form and you can ask your study doctor 
for more information. 

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APPENDIX XI: POMALIDOMIDE COUNSELING PROGRAM SITE COUNSELOR 
IDENTIFICATION FORM 
• 
Please identify at least two (2) counselors and fax back to 888-314-2392 
• 
Use one form per counselor. 
• 
Identified counselors must be licensed healthcare professionals (e.g. RN, PA, RPh, PhD, 
LPN, CNP, or MD) and must not be the principal investigator. 
• 
If you have any questions, please email (coop_ma@celgene.com) 
 
 
 
□ 
□
□ 
□
□ 
□
 
Celgene 
Corporation 
Celgene Pregnancy Prevention & Counseling Program Site 
Counselor Identification Form 
NCI Protocol #: AMC-100 
 
 
General Information 
Principal Investigator: 
Institution Name: 
Counselor Information 
CTEP person ID:
CTEP site ID: 
First Name: 
Middle Initial:
Last Name: 
License Type: (circle one) MD PhD 
PA 
CNP 
RN 
LPN RPh 
Other: 
Email Address: 
Phone: 
Fax: 
Institution Street Address: 
City: 
State/Region: 
Zip/Post Code: 
Country: 
Which training will you require? 
Were you previously approved as a Counselor? 
No 
Adult 
Pediatric 
If no, please list all the protocols #(s), corresponding CTEPsiteID(s) and institution names(s) that you 
plan to provide counseling for: 
If yes, please list the protocols #(s), corresponding CTEPsiteID(s) and institution names(s) for protocols 
Celgene has already associated you with: 
Document A_Version 3.1 1/28/2015 
Page 1 of 1
Protocol#: 
CTEPsiteID 
Institution 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Yes (Previous training) 
Adult 
Pediatric 

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APPENDIX XII: COLLECTION AND SHIPPING INSTRUCTIONS FOR PERIPHERAL 
BLOOD FOR IMMUNE RESPONSE (CYTOKINES AND SOLUBLE 
RECEPTORS) 
1.0 
OBJECTIVES 
The aims of this correlative study are to evaluate the effect of therapy with pomalidomide 
on serum levels of biomarkers of immune activation to identify the clinical correlates with 
regard to tumor response. 
2.0 
BACKGROUND 
Pomalidomide 
was 
designed 
to 
further 
increase 
the 
anti-angiogenic 
and 
immunomodulatory effects compared to the prior IMiD compounds. Pomalidomide 
promotes T helper cell (Th)-1 differentiation in vitro (Xu 2008) and increased Th-1 
cytokine production in animal models (Dredge 2002). 
It is unknown to what extent pomalidomide will alter the cytokine environment in 
participants with HIV-associated Kaposi sarcoma. Additionally, it is unclear if changes to 
the cytokine environment can be correlated with tumor response. 
Serum samples will be collected at baseline, after cycle 2, and at treatment discontinuation 
for testing for CRP, VEGF (angiogenesis), IP10/CXCL10 (an IFN-inducible 
inflammation-associated chemokine), IL8, TNF-alpha, IL17A, IL17E, IL6, IFN-gamma, 
and IL10 (inflammation-associated cytokines), and soluble (s)TNF-receptor type 2 
(sTNFR2), sCD27 (a TNFR family molecule), sIL2R alpha, sCD14 and sCD163 as 
macrophage activation/inflammation-associated molecules. Assays will be performed 
using the Luminex platform (Luminex, Austin, Texas, USA), using multiplexed 
fluorescent bead-based assays (R&D Systems, Minneapolis, MN) at the AMC Protein 
Biomarker Profiling Core Laboratory. 
Luminex assay data will be analyzed using a BioPlex 200 apparatus and BioPlex Manager 
software (Bio-Rad, Hercules, California, USA). All samples from an individual will be 
tested on one plate to minimize variability. Results will be correlated with clinical 
responses to provide preliminary information on the cytokines that may play a role in 
pomalidomide’s activity against KS. 
3.0 
RATIONALE 
The recent availability of multiplexed immunometric assays has made possible the 
simultaneous assessment of several of these immune activation and inflammation-
associated factors, using small volumes (<500 µl) of serum or plasma. 
The results of this study will provide information on immune activation/inflammation-
associated biomarker serum levels in HIV+ cancer participants treated with pomalidomide. 
4.0 
EVALUATIONS 
Serum levels of cytokines and inflammation-associated molecules will be determined at 
the following study visits: pre-study (entry), and after cycle 2 of therapy, and then after 
cycle 6 or at the early discontinuation visit. 
 
 

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5.0 
ANALYSES 
The working hypothesis that will be tested is that participants who are treated with 
pomalidomide will display elevated levels of T cell-produced cytokines following 
treatment initiation, and that the level of T cell cytokine responses will diminish with time, 
following the conclusion of therapy. 
Levels of cytokines and inflammation-associated biomarkers will be determined using two 
multiplexed (Luminex platform) panels. Testing for CRP, VEGF (angiogenesis), 
IP10/CXCL10 (an IFN-inducible inflammation-associated chemokine), IL8, TNF-alpha, 
IL17A, IL17E, IL6, IFN-gamma, and IL10 (inflammation-associated cytokines), and 
soluble (s)TNF-receptor type 2 (sTNFR2), sCD27 (a TNFR family molecule), sIL2R alpha, 
sCD14 and sCD163 as macrophage activation/inflammation-associated molecules will be 
performed, using multiplexed assays from R&D Systems. Analysis will be performed 
using the Luminex platform, a fluorescent bead-based assay. 
Samples will be processed on site and shipped to the AMC SSA Biorepository for storage. 
At the end of the study, serum will be sent in batch to the AMC Biomarkers Laboratory 
(Epeldegui laboratory at UCLA) for analysis. 
6.0 
SHIPPING INSTRUCTIONS AND SAMPLE PROCESSING 
Refer to the AMC-100 Manual of Procedures for instructions. 
 
 

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APPENDIX XIII: KS STAGING CRITERIA 
 
GOOD RISK (0) 
(All of the following) 
POOR RISK (1) 
(Any of the following) 
Tumor (T) 
- Confined to skin and/or 
lymph nodes and/or 
minimal oral disease1 
- Tumor-associated edema or 
ulceration 
- Extensive oral KS 
- Gastrointestinal KS 
- KS in other nonnodal viscera 
Immune system (I) 
- CD4 cells > 200/µL 
- CD4 cells < 200/µL 
Systemic illness (S) 
- No history of OI or 
thrush 
- No "B" symptoms2 
- Performance status > 70 
(Karnofsky) 
- History of OI and/or thrush 
- "B" symptoms present 
- Performance status < 70 
- Other HIV-related illness (e.g., 
neurological disease, lymphoma) 
T0 = 
tumor confined to skin, lymph nodes and/or minimal oral disease. 
T1 = 
any tumor falling under the "Poor Risk" criteria. 
S0 = 
no history of OI or thrush, no "B" symptoms, and Karnofsky Performance status > 70. 
S1 = 
any "Poor Risk" systemic illness signs and symptoms. 
NOTE: Staging criteria taken from: Krown SE, Metroka C, Wernz JC. Kaposi's sarcoma in the 
acquired immunodeficiency syndrome: A proposal for uniform evaluation, response, and 
staging criteria. J Clin Oncol 1989; 7: 1201-1207. These criteria were adopted by the 
ACTG Oncology Committee. 
 
1 Minimal oral disease is nonnodular KS confined to the palate. 
2 "B" symptoms are unexplained fever, night sweats, > 10% involuntary weight loss, or diarrhea persisting more than 
2 weeks. 

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APPENDIX XIV: AIDS MALIGNANCY CONSORTIUM (AMC) DATA SHARING 
PLAN 
The National Institutes of Health (NIH) requires the sharing of final research data generated from 
NIH funded studies with the research community for research purposes. The NIH Data Sharing 
Policy (https://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm) lists many 
reasons for sharing data from NIH-supported studies. Data to be shared may include aggregate 
data (e.g., summary statistics and tables), as well as individual-level data. The primary sources of 
AIDS Malignancy Consortium (AMC) data are the Clinical Data Commons and the Lab Data 
Commons. In all cases the Operations and Data Management Center (ODMC) will code data 
shared beyond the ODMC and Statistical and Data Analysis Center (SDAC) in such a way as to 
protect privacy concerns with respect to sensitive data. Prior to making data from a specific AMC 
study available for sharing, the ODMC will construct a data dictionary describing data elements 
available from that study so that interested parties may be informed of what data are available for 
request. For studies where the AMC sites participate and enroll study participants, but the data 
management activities are supported by another entity such as a data coordinating center for 
another clinical trial network, or studies that include another entity and the ODMC and SDAC 
support the study, data sharing policies and procedures will be determined through negotiations 
between the AMC and the other entity(ies). 
I. 
Data Access 
a. Within the AMC 
AMC investigators may request de-identified data from completed AMC studies for the pursuit of 
research questions ancillary to the protocol-specified study aims. AMC investigators must submit 
a written Ancillary Study Form to the AMC Executive Committee detailing the research question, 
the analytic approach, publication plans, and the data required for the proposed study for review 
and approval. Upon approval of the request by the AMC Executive Committee, the requester will 
be required to sign a Data Use Agreement with the ODMC which covers data analysis, data 
confidentiality, authorship, and intellectual property sharing prior to release of the data. Requests 
to have a statistical analyst outside of the AMC SDAC perform the data analysis requires Executive 
Committee approval. 
b. Outside the AMC 
There are currently no plans to release the individual participant-level data to investigators 
outside of the AMC until release of the data to a public data repository. If the AMC leadership 
determines that individual participant-level data will be shared with investigators outside of the 
AMC, an SOP will be developed to describe the process. 
II. 
Public Use Dataset 
It is anticipated that following the acceptance of a manuscript that addresses the primary and 
secondary objectives of an AMC clinical trial, the ODMC will establish a CDISC-mapped, de-
identified version of the data with appropriate documentation to be submitted to a public data 
repository such as the National Clinical Trials Network (NCTN) Data Archives. 
 

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III. 
Model Organisms 
At present, no new, genetically modified variants of model organisms (including non-human 
mammalian and non-mammalian eukaryotic models) will be generated. In the event that model 
organisms are generated from future studies, we will adhere to the NIH Grant Policy Sharing 
Model Organisms (effective October 2018). 
IV. 
Genomic Data Sharing 
To date, no genome-wide association studies (GWAS) have been proposed. In the event that future 
studies proposed by the AMC include GWAS studies, we will follow the NIH Grants Policy 
Genomic Data Sharing (GDS) Policy/Policy for Genome-Wide Association Studies (GWAS) 
(effective October 2018). AMC will work to ensure that, with IRB approval, the GWAS data 
generated by AMC projects are deposited into NIH’s Database of Genotype and Phenotype 
(dbGaP) housed at the National Center for Biotechnology Information in the National Library of 
Medicine where they may be available to the broader research community. Data will be released 
no later than after acceptance for publication of the main findings of these studies