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|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|  
| Version Date: 11/02/2020                                                               |                                                                                                               |
|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| 3.5.2                                                                                  | Long-term Follow-up                                                                                           |
| Study Calendar .                                                                       |                                                                                                               |
| 3.6                                                                                    |                                                                                                               |
| 3.7                                                                                    | Cost and Compensation                                                                                         |
| Costs                                                                                  |                                                                                                               |
| 3.7.1                                                                                  |                                                                                                               |
| 3.7.2                                                                                  | COMPENSATION .                                                                                                |
| 3.7.3                                                                                  | REIMBURSEMENT                                                                                                 |
| 3.8                                                                                    | Criteria for Removal from Protocol Therapy and Off Study Criteria ................................ 28         |
| 3.8.1                                                                                  | Criteria for Removal from Protocol Therapy                                                                    |
| 3.8.2                                                                                  | Off Study Criteria .                                                                                          |
| 3.8.3                                                                                  | Lost to Follow-up.                                                                                            |
| CONCOMITANT MEDICATIONS / MEASURES .                                                   |                                                                                                               |
| 4                                                                                      |                                                                                                               |
| S                                                                                      | BIOSPECIMEN COLLECTION                                                                                        |
| CORRELATIVE STUDIES FOR RESEARCH .                                                     |                                                                                                               |
| 5.1                                                                                    |                                                                                                               |
| 5.1.1                                                                                  | T Tissue .                                                                                                    |
| 5.1.2                                                                                  | Blood                                                                                                         |
| 5.2                                                                                    | SAMPLE STORAGE, TRACKING AND DISPOSITION .                                                                    |
| 5.2.1                                                                                  | Samples Managed by Dr. Figg's Blood Processing Core (BPC)................................. 30                 |
| 5.2.2                                                                                  | Procedures for Storage of Tissue Specimens in the Laboratory of Pathology ...... 31                           |
| 5.2.3                                                                                  | Protocol Completion/Sample Destruction .                                                                      |
| Samples for Genetic/Genomic Analysis .                                                 |                                                                                                               |
| 5.3                                                                                    |                                                                                                               |
| 5.3.1                                                                                  | Description of the scope of genetic/genomic analysis ..................................................... 32 |
| 5.3.2                                                                                  | Pharmacogenomic Studies (Cohort 1 only)                                                                       |
| Privacy and Confidentiality of medical information/biological specimens ........... 32 |                                                                                                               |
| 5.3.3                                                                                  |                                                                                                               |
| 5.3.4                                                                                  | A Certificate of Confidentiality will be obtained for the study as described in section                       |
| 12.4.5.                                                                                | 33                                                                                                            |
| Management of Results                                                                  |                                                                                                               |
| 5.3.5                                                                                  |                                                                                                               |
| 6                                                                                      | DATA COLLECTION AND EVALUATION                                                                                |
| DATA COLLECTION                                                                        |                                                                                                               |
| 6.1                                                                                    | DATA SHARING Plans .                                                                                          |
| 6.2                                                                                    | Human Data Sharing Plan.                                                                                      |
| 6.2.1                                                                                  |                                                                                                               |
| 6.2.2                                                                                  | Genomic Data Sharing Plan.                                                                                    |
| Response Criteria                                                                      |                                                                                                               |
| 6.3                                                                                    |                                                                                                               |
| 6.3.1                                                                                  | Disease Parameters .                                                                                          |
| 6.3.2                                                                                  | Methods for Evaluation of Measurable Disease .                                                                |
| RANO Disease Response Criteria .                                                       |                                                                                                               |
| 6.3.3                                                                                  |                                                                                                               |
| 6.3.4                                                                                  | Evaluation of Best Overall Response                                                                           |
| 6.3.5                                                                                  | D DURATION OF RESPONSE                                                                                        |
| Progression-Free Survival                                                              |                                                                                                               |
| 6.3.6                                                                                  |                                                                                                               |
| 6.3.7                                                                                  | Overall survival                                                                                              |
| Toxicity Criteria                                                                      |                                                                                                               |
| 6.4                                                                                    |                                                                                                               |
| 7                                                                                      | NIH REPORTING REQUIREMENTS / DATA AND SAFETY MONITORING PLAN....... 37                                        |
| Definitions                                                                            |                                                                                                               |
| 7.1                                                                                    |                                                                                                               |  
| Version Date: 11/02/2020                                                                                              |                                                                                                            |             |
|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-------------|
| 7.2                                                                                                                   | OHSRP Office of Compliance and Training/IRB Reporting ................................................. 37 |             |
| 7.2.1                                                                                                                 | Expedited Reporting                                                                                        |             |
| 7.2.2                                                                                                                 | IRB Requirements for PI Reporting at Continuing Review ........................................ 37         |             |
| 7.3                                                                                                                   | NIH Required Data and Safety Monitoring Plan .                                                             |             |
| 7.3.1                                                                                                                 | Principal Investigator/Research Team .                                                                     |             |
| SPONSOR SAFETY REPORTING .                                                                                            |                                                                                                            |             |
| 8                                                                                                                     | 8.1                                                                                                        | DEFINITIONS |
| Adverse Event                                                                                                         |                                                                                                            |             |
| 8.1.1                                                                                                                 |                                                                                                            |             |
| 8.1.2                                                                                                                 | Serious Adverse Event (SAE)                                                                                |             |
| 8.1.3                                                                                                                 | Life-threatening                                                                                           |             |
| 8.1.4                                                                                                                 | SE SEE                                                                                                     |             |
| 8.1.5                                                                                                                 | Relationship to Study Product                                                                              |             |
| 8.1.6                                                                                                                 | Events of Clinical Interest (ECI) - CNS adverse events ............................................ 39     |             |
| Assessment of Safety Events                                                                                           |                                                                                                            |             |
| 8.2                                                                                                                   |                                                                                                            |             |
| 8.3                                                                                                                   | Reporting of Serious Adverse Events                                                                        |             |
| Safety Reporting Criteria to the Pharmaceutical Collaborator............................................. 39          |                                                                                                            |             |
| 8.4                                                                                                                   |                                                                                                            |             |
| 8.4.1                                                                                                                 | Serious Adverse Events .                                                                                   |             |
| 8.4.2                                                                                                                 | Pregnancy                                                                                                  |             |
| Events of Clinical Interest (ECI): Hallucinations ................................................................ 41 |                                                                                                            |             |
| 8.4.3                                                                                                                 |                                                                                                            |             |
| 8.5                                                                                                                   | Reporting Pregnancy                                                                                        |             |
| 8.5.1                                                                                                                 | MM                                                                                                         |             |
| 8.5.2                                                                                                                 | Paternal exposure                                                                                          |             |
| Regulatory Reporting for Studies Conducted Under CCR-Sponsored IND .................. 41                              |                                                                                                            |             |
| 8.6                                                                                                                   |                                                                                                            |             |
| 9                                                                                                                     | CLINICAL MONITORING                                                                                        |             |
| 10                                                                                                                    | STATISTICAL CONSIDERATIONS                                                                                 |             |
| 10.1                                                                                                                  | Statistical Hypothesis .                                                                                   |             |
| Primary Endpoint:                                                                                                     |                                                                                                            |             |
| 10.1.1                                                                                                                |                                                                                                            |             |
| 10.1.2                                                                                                                | Secondary Endpoint(s):                                                                                     |             |
| Sample Size Determination                                                                                             |                                                                                                            |             |
| 10.2                                                                                                                  |                                                                                                            |             |
| 10.3                                                                                                                  | Populations For Analysis .                                                                                 |             |
| Statistical Analyses .                                                                                                |                                                                                                            |             |
| 10.4                                                                                                                  |                                                                                                            |             |
| 10.4.1                                                                                                                | Analysis of the Primary Endpoint:                                                                          |             |
| 10.4.2                                                                                                                | Analysis of the Secondary Endpoint(s)                                                                      |             |
| 10.4.3                                                                                                                | Se                                                                                                         |             |
| 10.4.4                                                                                                                | Planned Interim Analyses .                                                                                 |             |
| 10.4.5                                                                                                                | Exploratory Analyses                                                                                       |             |
| l l                                                                                                                   | COLLABORATIVE AGREEMENTS .                                                                                 |             |
| CRADA                                                                                                                 |                                                                                                            |             |
| 1.1                                                                                                                   |                                                                                                            |             |
| 12                                                                                                                    | HUMAN SUBJECTS PROTECTIONS .                                                                               |             |
| Rationale For Subject Selection                                                                                       |                                                                                                            |             |
| 12.1                                                                                                                  |                                                                                                            |             |
| 12.2                                                                                                                  | Participation of Children/Viable Neonates                                                                  |             |
untitled h1
abbreviated title ph ii ep

| Version Date: 11/02/2020                                                                   |                                                                                                                            |                                   |
|--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| 12.3                                                                                       | Participation Of Neonates Of Uncertain Viability And Nonviable Neonates ................ 46                                |                                   |
| Neonates of Uncertain Viability                                                            |                                                                                                                            |                                   |
| 12.3.1                                                                                     |                                                                                                                            |                                   |
| 12.3.2                                                                                     | Nonviable Neonates .                                                                                                       |                                   |
| Participation of Pregnant Women                                                            |                                                                                                                            |                                   |
| 12.4                                                                                       |                                                                                                                            |                                   |
| 12.5                                                                                       | Participation of Subjects Unable to Give Consent ...................................................................... 47 |                                   |
| Potential Risks/ Discomforts .                                                             |                                                                                                                            |                                   |
| 12.6                                                                                       |                                                                                                                            |                                   |
| 12.6.1                                                                                     | Study Drug Risks .                                                                                                         |                                   |
| 12.6.2                                                                                     | Imaging                                                                                                                    |                                   |
| 12.6.3                                                                                     | Research Blood Collection Risks.                                                                                           |                                   |
| 12.6.4                                                                                     | EKG                                                                                                                        |                                   |
| 12.6.5                                                                                     | O OTHER RISKS                                                                                                              |                                   |
| 12.6.6                                                                                     | Questionnaires risks .                                                                                                     |                                   |
| 12.6.7                                                                                     | Non-Physical Risks of Genetic Research ............................................................................ 48     |                                   |
| 12.6.8                                                                                     | Certificate of Confidentiality .                                                                                           |                                   |
| 12.6.9                                                                                     | Potential Benefits .                                                                                                       |                                   |
| 12.7                                                                                       | Risks/Benefits Analysis                                                                                                    |                                   |
| Consent Process and Documentation                                                          |                                                                                                                            |                                   |
| 12.8                                                                                       |                                                                                                                            |                                   |
| 12.8.1                                                                                     | Consent Process for Adults Who Lack Capacity to Consent to Research Participation                                          |                                   |
| 49                                                                                         |                                                                                                                            |                                   |
| 12.8.2                                                                                     | Consent for Children and Neonates                                                                                          |                                   |
| 12.8.3                                                                                     | Request for Waiver of Consent for Screening Activities                                                                     |                                   |
| REGULATORY AND OPERATIONAL CONSIDERATIONS                                                  |                                                                                                                            |                                   |
| 13                                                                                         | 13.1                                                                                                                       | Study Discontinuation and Closure |
| Quality Assurance and Quality Control                                                      |                                                                                                                            |                                   |
| 13.2                                                                                       |                                                                                                                            |                                   |
| 13.3                                                                                       | Conflict of Interest Policy                                                                                                |                                   |
| Confidentiality and Privacy.                                                               |                                                                                                                            |                                   |
| 13.4                                                                                       |                                                                                                                            |                                   |
| 14                                                                                         | PHARMACEUTICAL INFORMATION                                                                                                 |                                   |
| MMARIZOMIB (IND 139633)                                                                    |                                                                                                                            |                                   |
| 14.1                                                                                       |                                                                                                                            |                                   |
| 14.1.1                                                                                     | SOURCE .                                                                                                                   |                                   |
| 14.1.2                                                                                     | Human Toxicity .                                                                                                           |                                   |
| Formulation and preparation                                                                |                                                                                                                            |                                   |
| 14.1.3                                                                                     |                                                                                                                            |                                   |
| 14.1.4                                                                                     | Stability and Storage                                                                                                      |                                   |
| 14.1.5                                                                                     | Administration procedures                                                                                                  |                                   |
| Incompatibilities                                                                          |                                                                                                                            |                                   |
| 14.1.6                                                                                     |                                                                                                                            |                                   |
| 14.1.7                                                                                     | Chemical name and structure:                                                                                               |                                   |
| REFERENCES .                                                                               |                                                                                                                            |                                   |
| 15                                                                                         |                                                                                                                            |                                   |
| 16                                                                                         | APPENDICES .                                                                                                               |                                   |
| Appendix A: Karnofsky Performance Status and Neurological Function .................... 57 |                                                                                                                            |                                   |
| 16.1                                                                                       |                                                                                                                            |                                   |
| 16.2                                                                                       | Appendix B: MRI Acquisition Protocol                                                                                       |                                   |
| 16.3                                                                                       | Appendix C: Hallucination Severity Scale                                                                                   |                                   |
| 16.4                                                                                       | Appendix D: Celgene Initial Pregnancy Report Form ............................................................... 62       |                                   |
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Creatinine up to 1.5-times upper institutional limits OR eGFR within normal as predicted by the CKD-EPI equation ( ≥ 60 mL/min/1.73m 2 ).  
Negative urine protein  or urine protein concentration ≤ 60 mg/dL
2.1.1.8 The effects of marizomib on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and up to 30 days after the last dose of the drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.  
2.1.1.9 Ability of subject to understand and the willingness to sign a written informed consent document. Anticancer treatment within designated period of time before enrollment including:
2.1.2.1 surgery within 14 days needle or core biopsy within 7 days vincristine within 14 days nitrosoureas within 42 days, procarbazine administration within 21 days non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid
(radiosensitizer does not count) within 7 days; Avastin within 21 days. Any questions related to the definition of non-cytotoxic agents should be directed to the NCI Principal Investigator.  
2.1.2.2 Treatment with any investigational agent within 28 days before enrollment.  
History of any other cancer (except non-melanoma skin cancer or carcinoma insitu of the cervix), unless patient is in complete remission and off all therapy for that disease for a minimum of 3 years.  
2.1.2.3 History of allergic reactions attributed to compounds of similar chemical or biologic composition to marizomib.  
2.1.2.4 2.1.2.5 Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.  
2.1.2.6 Inadequately controlled hypertension (defined as systolic blood pressure > 140 mHg and/or diastolic blood pressure > 90 mmHg).  
2.1.2.7 Current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, or stable chronic liver disease per
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2.1.2

prior cytotoxic therapy within 28 days, Exclusion Criteria A
A A
A A A
A
investigator assessment).  
2.1.2.8 New York Heart Association (NYHA) Grade II heart failure or greater or history of hospitalization for congestive heart failure diagnosis within 12 months prior to enrollment.
2.1.2.9  
History of myocardial infarction or unstable angina within 3 months prior to enrollment.  
2.1.2.10 A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >480 milliseconds (ms) (CTCAE grade 1) using Frederica's QT correction formula.  
2.1.2.11 A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).  
2.1.2.12 Current use of concomitant medications that prolong the QT/QTc interval
2.1.2.13 History of stroke or transient ischemic attack within 3 months prior to enrollment.  
2.1.2.14 Pregnant women are excluded from this study because marizomib's potential for teratogenic or abortifacient effects is unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with marizomib, breastfeeding should be discontinued if the mother is treated with marizomib.  
2.1.2.15 Patients receiving combination antiretroviral therapy for treatment of Human Immunodeficiency Virus (HIV) or active anti-viral treatment for Hepatitis A, B or C infection. Anti-viral therapy, when combined with marizomib, poses a potential for pharmacokinetic interactions. Marizomib also increases immunosuppression, placing patients at an increased risk of acquiring lethal infections. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
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2.1.3 inclusion criteria for pregnancy

Because the drug manufacturer would like to study the effect of the study therapy on pregnancy, and because the required information cannot be collected unless a subject is enrolled per ruling of the OGC, the following additional groups of subjects may be enrolled if necessary.  The subjects enrolled in this cohort will not meet the inclusion and exclusion criteria found in 2.1.1 and 2.1.2.  
.  
A child whose parent (male or female) is/was an active participant in the study at any time during the child's gestation.  Active participant is defined as having received at least one dose of study therapy through 6 months after the last dose of study therapy.
OR
.  
An expectant mother of child whose father is/was an active participant in the study at any time during the child's gestation. The father must have received at least one dose of study therapy. Active participant is defined as having received at least one dose of study therapy through 6 months after the last dose of study therapy.  
.  
The expectant mother must be age 18 or older and must have the capacity to provide informed cnsn .
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| YtyzlkYqyl   | ^lo{knspnjr                                                                                                                                                    |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| #            | H'&'):#8*.|34:(M0:&01:),b4),10,-')(%01,-DEFb;*(0'13%3159/'/,M&'&,L3 &,51'13+#')@%)0')4&3/':&3),%03(A                                                                                                                                                                |
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| YtyzlkYqyl   | ^lo{knspnjr          |                                                           |
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| #            | d)/#                 | ,)0€'/0.,:5,9(#+$,15#B';3,4&@$b5,9494-3                                                           |
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| q/'9%(02 r. %(02                              | s*+&'()*+(,2*5/'/2I:1(*77//2/2                                                                                                                                                                                                                                                                                            |
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| 56(3)24789                                            |                    |                  |    |    |                    |    |    |    |
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| :8;<=7>*162?4                                         | 8;@162 AB44        | C'-/D)&E AB4FG44 |    |    |                    |    |    |    |
| @1624                                                 |                    |                  |    |    |                    |    |    |    |
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| LMNOPQbcdefghijPhiMklhcPmnlomP  FH5K4-0(2-0&%,-F23:,132IS`J   |                    |           |                           |             |
|---------------------------------------------------------------|--------------------|-----------|---------------------------|-------------|
|                                                               | 4F                 | @F        | 6?                        | @?          |
| W>.&7,8010*+21)&1'01.7032&32                                  |  5,12              |  p$qrs    | t$qrsB*( tS$ru  pS$r uvv> |             |
| WSwZYHGF                                                      | 6(&B82,-s6(&B82,-s | 6(&B82,-s | uvv>                      |             |
| 52/8230,1                                                     | 5,12               | 5,12      | 5,12                      | @-2321(vv>  |
| 4,-(0',3(2-,073                                               | 5,12               | 6(&B82,-s | 6(&B82,-s                 | 1w&vvx      |
| 48010'&83(&(*3                                                | 6(&B82,-u6(&B82,-u | 6(&B82,-u | svv>                      |             |
| F2[*0-2+21(%,--23:,132                                        | H88                | H88       | H88                       | H19>        |  
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| 2TUVWXYZ[(\UXWU]TV^\.^T_\   |                                                                    |
|-----------------------------|--------------------------------------------------------------------|
| <@EI@A>                     | `@CIE?D>?GA                                                        |
| abb                         | LGEH=McAGIGHDM=?A>CcAG@d?K@AI@GFK?C@=C@e                           |
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| jb                          | LGEH=M=I>?d?>hP?>R@FFGE>iCGH@C?NACGEChHD>GHCGFK?C@=C@e             |
| $b                          | k=E@CFGEC@MFcJA=QM@>GI=EEhGAAGEH=M=I>?d?>hGE>GKG=I>?d@PGEle        |
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| ab                          | wGE?QJAKcF=>=MDEGI@CC@CDEGNE@CC?ANE=D?KMhe                         |
| b                           | `@=Ke                                                              |  
|                    |                  |
|--------------------|------------------|
| %&'()*)+,-.'/-0,)/ |                  |
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| ZN                 | X9554E?F[9>57    |
| ZP                 | V7;4<487?F[9>57  |
| W                  | WC57?4<7         |  
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|                   |                                             |         |        |    |    |
|-------------------|---------------------------------------------|---------|--------|----|----|
|                   | );<=>?>@>ABCDA@A;AE                         |         |        |    |    |
|  FGHIJKLMNOPQRJHI | STUNPV                                      |         |        |    |    |
|                   | FWXYKRJPIXLQIZ[                             |         | STUNPV |    |    |
|                   | F\NO]XYQJMHINJPZT^JMHUY                     | S#UNPV  |        |    |    |
|                   | F_`Gab                                      |         | ScUNPV |    |    |
|                   | Fde`fgGh`SijklV                                             | S[mUNPV |        |    |    |
|                   | FWXYKRJPIXLQInLXNLoMYpMNqLPOMYZ[ULqQ S[UNPV |         |        |    |    |
|                   | FWYXUYLoNMNIrSZ[srPLUNRV                    | StUNPV  |        |    |    |
|                   | FWJQIKRJPIXLQInLXNLoMYpMNqLPOMYZ[ULqQS[UNPV |         |        |    |    |
|                   | FfNppHQNJPZYPQJXaULONPO                     | SuUNPV  |        |    |    |
|                   | FWYXpHQNJPSZTgZTvV                          | ScUNPV  |        |    |    |
|                   | FcfWJQIKRJPIXLQI                            | S#UNPV  |        |    |    |
|                   | FWJQIKRJPIXLQIZ[                            | STUNPV  |        |    |    |
|                   |                                             |         |        |    |    |  
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|                  |                                                                                                                                                                                                                                                                                                                                   |
untitled h1
pregnancy form completion guidelines for

Any pregnancy that occurs during a clinical study with an investigational drug will be reported for tracking purposes only.  
Pregnancy complications and abnormal outcomes must be reported as Adverse Events (AEs).  If a pregnancy complication or abnormal outcome meets any of the serious criteria, it must be reported as a Serious Adverse Event (SAE) to Celgene Drug Safety using the SAE Report Form.  
All pregnancies and suspected pregnancies (e.g., reports of elevated, questionable or indeterminate beta human chorionic gonadotropins in females of child bearing potential or positive urine pregnancy test) of female subjects or female partners of male subjects (and exposures of other pregnant females if required by protocol) that occur during the period defined in the protocol must be reported to Celgene Drug Safety immediately using the Pregnancy Initial Report Form.  
All such pregnancies and suspected pregnancies occurring during the study will be followed until delivery.  
or other outcome, if possible.  The outcome must be reported to Celgene Drug Safety immediately using the Pregnancy Follow-up Report Form. The Initial report will be completed with initial pregnancy data.  The Follow-up report will be completed with ongoing pregnancy data and/or pregnancy outcome data.  
The Header and Demographic Information, and Study Drug Information should be completed based on the study subject.  All other information, e.g., Concomitant Medications, Diagnostic Tests, Complications and other pregnancy information should pertain to the pregnant female.  
Each Pregnancy form must be completed in English. Please print or type all entries in blue or black ink.  
Dates should be entered in dd/mmm/yyy format (e.g., August 21, 2009 = 21/AUG/2009).  
Provide all available information at the time of form completion.  If any information is unknown, enter
"UNK" in the space provided rather than leaving it blank.  
Fax the completed Pregnancy Reporting form(s) to the appropriate Celgene Drug Safety local office corresponding to your country as per the directory found at the end of this document.  
Retain a copy of the successful fax transmission report along with the pregnancy form in your study file.  
If your fax machine does not provide a transmission report, annotate the pregnancy form with the date.  
and time it was faxed to Celgene.  
You may also email the pregnancy form to the Celgene Drug Safety local office email provided at the end of this document. Please print a copy of the sent email for your files. All emailed forms still ultimately require the Investigator's signature.  
| Completion of Pregnancy Initial Report Form                   |                                                                |                                                                  |
|---------------------------------------------------------------|----------------------------------------------------------------|------------------------------------------------------------------|
| Header and Demographic                                        | Enter the Protocol Number in the space provided                |                                                                  |
| Information                                                   | Record the date the site first became aware of the pregnancy,  |                                                                  |
| .                                                             | suspected pregnancy or exposure                                |                                                                  |
| .                                                             | Record the name of the Principal Investigator at the site      |                                                                  |
| Record the subject initials as recorded in the Case Report    |                                                                |                                                                  |
| .                                                             | Form                                                           |                                                                  |
| Record the 3-digit site number assigned to the study site     |                                                                |                                                                  |
| .                                                             |                                                                |                                                                  |
| .                                                             | Record the 4-digit subject number that was assigned to the     |                                                                  |
| subject                                                       |                                                                |                                                                  |
| Record the subject's age at the time of the pregnancy         |                                                                |                                                                  |
| .                                                             |                                                                |                                                                  |
| .                                                             | Record the sex of the study subject, regardless of whether the |                                                                  |
| pregnant female is the study subject or not                   |                                                                |                                                                  |
| .                                                             | Record the type of pregnancy being reported, i.e., pregnancy   |                                                                  |
| of a female subject, pregnancy of a female partner of a male  |                                                                |                                                                  |
| subject, suspected pregnancy or exposure of a pregnant        |                                                                |                                                                  |
| female                                                        |                                                                |                                                                  |
| .                                                             | Record subject's race; check one box, unless the race is not   |                                                                  |
| listed then check other and specify                           |                                                                |                                                                  |
| Pregnancy Information                                         | .                                                              | For female subjects only, record the date of the Screening       |
| pregnancy test using the following format: dd/mmm/yyy, and    |                                                                |                                                                  |
| check the corresponding result box                            |                                                                |                                                                  |
| Record the date of the last menstrual period using the        |                                                                |                                                                  |
| .                                                             | following format: dd/mm/yyy                                    |                                                                  |
| .                                                             | Record the total number of prior pregnancies                   |                                                                  |
| .                                                             | Record the number of prior live births                         |                                                                  |
| .                                                             | Record the number of terminated pregnancies (spontaneous       |                                                                  |
| or elective)                                                  |                                                                |                                                                  |
| Record history of congenital anomalies with prior pregnancies |                                                                |                                                                  |
| .                                                             | by checking the appropriate box                                |                                                                  |
| .                                                             | Record history of familial congenital anomalies by checking    |                                                                  |
| the appropriate box                                           |                                                                |                                                                  |
| Concomitant Medication                                        | .                                                              | Include all medications taken at the time of study entry, during |
| Information                                                   | study treatment, and at the time of conception (additional     |                                                                  |
| pages can be attached as necessary)                           |                                                                |                                                                  |
| Study Drug Information                                        | .                                                              | Record the study drug name received by the study subject or      |
| indicate blinded treatment as appropriate                     |                                                                |                                                                  |
| .                                                             | Record the date of first dose and the date of the last dose    |                                                                  |
| using the following format: dd/mmm/yyy                        |                                                                |                                                                  |
| Method of Birth Control                                       | Record all methods in use since starting study drug            |                                                                  |
| .                                                             |                                                                |                                                                  |
| Information                                                   |                                                                |                                                                  |  
  
| Pregnancy Diagnosis                                              | Record the type of pregnancy test initially used              |                                                                  |
|------------------------------------------------------------------|---------------------------------------------------------------|------------------------------------------------------------------|
| .                                                                |                                                               |                                                                  |
| Information                                                      | .                                                             | Provide the date pregnancy test was performed using the          |
| following format: dd/mmm/yyy                                     |                                                               |                                                                  |
| Pregnancy Status                                                 | .                                                             | Record the number of weeks the female is pregnant OR check       |
| Information                                                      | "No longer Pregnant" if the pregnancy has ended (if no longer |                                                                  |
| pregnant, complete a Pregnancy Follow-up Report)                 |                                                               |                                                                  |
| Indicate whether the female plans to carry the pregnancy to      |                                                               |                                                                  |
| .                                                                | term or plans to terminate the pregnancy                      |                                                                  |
| If the female plans to carry to term, provide the expected date  |                                                               |                                                                  |
| .                                                                | of delivery using the following format: dd/mmm/yyyy           |                                                                  |
| Provide the date of pregnancy termination or circle "Pending"    |                                                               |                                                                  |
| .                                                                | if date is not known                                          |                                                                  |
| Summary of Diagnostic                                            | .                                                             | Indicate if any diagnostic tests were performed by checking      |
| "None" or listing the tests and their results as appropriate     |                                                               |                                                                  |
| Tests Information                                                | .                                                             | Do not include pregnancy test information here                   |
| Pregnancy Complication                                           | .                                                             | Indicate if any pregnancy complications have occurred by         |
| Information                                                      | checking "None" or summarizing the complications as           |                                                                  |
| appropriate                                                      |                                                               |                                                                  |
| Form Completion                                                  | .                                                             | Print the name of the Investigator and obtain the Investigator's |
| Information                                                      | signature                                                     |                                                                  |
| .                                                                | Record the date (dd/mmm/yyy) the Investigator signed the      |                                                                  |
| report                                                           |                                                               |                                                                  |
| Print the name of the reporter, include the reporter's signature |                                                               |                                                                  |
| .                                                                | Record the date (dd/mmm/yyy) the reporter signed the report   |                                                                  |
| .                                                                |                                                               |                                                                  |
| .                                                                | Document the reporter's phone number, fax number and email    |                                                                  |
| adress                                                           |                                                               |                                                                  |