Clinical trial NCT01903811
Conditions: Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma
Keywords: carfilzomib relapsed refractory multiple myeloma
Sponsor: SWOG Cancer Research Network
Start date: 2013-10-01; Completion date: 2019-03-07
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This randomized phase II trial compares how well two different doses of carfilzomib work when given with dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement or has not responded to treatment. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carfilzomib together with dexamethasone may kill more cancer cells. It is not yet known whether a higher or lower dose of carfilzomib works better when given with dexamethasone.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate and compare progression free survival (PFS) of two different doses of carfilzomib with dexamethasone in multiple myeloma (MM) patients with relapsed and/or refractory disease.

SECONDARY OBJECTIVES:

I. To evaluate and compare response rates (RR) for each arm. II. To evaluate response rates (RR) for patients that relapse on low dose carfilzomib and subsequently cross-over to high dose carfilzomib.

III. To evaluate the safety of this combination for this patient population. IV. To evaluate overall survival (OS).

TERTIARY OBJECTIVES:

I. To explore the molecular variability in MM cells obtained from extramedullary bone marrow relapse sites.

II. To explore the role of positron emission tomography (PET) scanning in assessing disease burden and as a tool to assess treatment response.

III. To explore changes in left ventricular ejection fraction (LVEF) in patients with relapsed or refractory multiple myeloma treated with low dose carfilzomib or high dose carfilzomib plus dexamethasone.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive dexamethasone intravenously (IV) and low-dose carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16. Patients with progression cross-over to Arm II.

ARM II: Patients receive dexamethasone IV and high-dose carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16.

Note that for the first course of treatment on both arms carfilzomib is given at a reduced rate to assess toxicity.

In both arms, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 3 years from initial registration.

Arms: arm 1: Patients receive dexamethasone IV and low-dose carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16. (Note that course 1 is given at a reduced dose.) Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with progression cross-over to Arm II. arm 2: Patients receive dexamethasone IV and high-dose carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. (Note that course 1 is given at a reduced dose over 2-10 minutes.) Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Carfilzomib intervention 2: Dexamethasone intervention 3: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Correlative studies

Protocol documents:
Prot_SAP_ICF_000.pdf: 
 
 
 
 
 
 
 
 
Distribution Date:  
September 15, 2018 
E-mailed Date: 
September 12, 2018 
 
 
 
 
TO: 
ALL NATIONAL CLINICAL TRIALS NETWORK (NCTN) MEMBERS 
 
 
FROM: 
SWOG Operations Office (protocols@swog.org) 
 
 
RE: 
McKesson Corporation Drug Distribution Delays 
 
 
MEMORANDUM 
 
 
 
The purpose of this memorandum is to inform sites of potential changes in 
delivery of drugs distributed by McKesson Corporation (formerly Biologics, Inc.). 
 
McKesson has indicated that they may hold shipments to zip codes in the path of 
hurricane Florence due to forecasted delivery issues posed by the storm.  They 
will continue to reach out to patients and sites in the most impacted areas in the 
Carolinas, Virginia and Washington, D.C. to help plan for delays, non-delivery, 
and closures.   They will monitor the storm and sites will be notified of updates as 
they arise.   
 
For urgent needs and questions regarding specific deliveries, please contact the 
team at clinicalresearchservices@mckesson.com or 1-800-693-4906. 
 
This memorandum pertains to the following studies: 
 
S1014 Genitourinary 
S1216 Genitourinary 
S1304 Myeloma 
S1313 Gastrointestinal 
S1403 Lung 
S1406 Gastrointestinal 
S1602 Genitourinary 
S1613 Gastrointestinal 
S1701 Lung 
 
This memorandum serves to notify the NCI, CIRB, and SWOG Statistics and Data 
Management Center. 
 
cc:  Elliott Lee – McKesson Corporation 


 
 
 
 
 
 
 
 
 
Distribution Date: March 1, 2017 
E-mail Date 
February 16, 2017 
 
 
 
TO:  
ALL NATIONAL CLINICAL TRIALS NETWORK (NCTN) MEMBERS 
 
 
FROM:  
SWOG Operations Office 
 
 
RE:  
Change in e-mail address for Biologics, Inc. 
 
MEMORANDUM 
 
IRB Review Requirements 
(   ) 
Full board review required    
(   ) 
Expedited review allowed 
(  ) No review required  
 
 
MEMORANDUM 
 
The purpose of this memorandum is to alert sites to a change in email address for 
Biologics, Inc., the drug distributor for the following studies: 
 
S1014 
S1216 
S1304 
S1313 
S1403 
S1406 
S1602 
 
Beginning February 20th, 2017, the email address clinicaltrials@biologicsinc.com will no 
longer be valid and clinicalresearchservices@biologicsinc.com will no longer be 
accepting drug order submissions. 
  
Please ensure all clinical trial drug order submissions that are emailed are being 
addressed to CRSorders@biologicsinc.com; all other communication outside of drug 
order 
submissions 
may 
continue 
to 
be 
addressed 
to 
clinicalresearchservices@biologicsinc.com.     
  
Please note CRSorders@biologicsinc.com will only allow for inbound submission. If you 
require a response to an inquiry regarding an order please ensure it is addressed to 
clinicalresearchservices@biologicsinc.com. 
  
Drug orders submitted via fax to 919-256-0794 will still be processed as usual. 
 
cc: PROTOCOL & INFORMATION OFFICE 
 


 
 
 
 
 
 
November 1, 2016 
 
TO: 
ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS; CTSU 
 
FROM: 
Cara Laubach, MIIM, Protocol Coordinator (E-mail:  claubach@swog.org) 
 
RE: 
S1304, “A Phase II Randomized Study Comparing Two Doses of Carfilzomib 
(NSC-756640) with Dexamethasone for Multiple Myeloma Patients with 
Relapsed or Refractory Disease”.  Study Chairs:  Drs. S. Ailawadhi, M.H. 
Abidi, S. Lentzsch, R.Z. Orlowski and E.M. Rohren. 
 
MEMORANDUM 
 
Study Chair:  Sikander A. Ailawadhi 
Phone number: 904/953-7290 
E-mail: S1304SC@swog.org 
 
IRB Review Requirements 
(   ) 
Full board review required    
(   ) 
Expedited review allowed 
(  ) No review required  
 
Status Change 
 
(   )  IRB Review only 
 
(   )  Activation 
(   )  Closure: Permanent 
(   )  Reactivation 
 
Protocol changes 
(   )  Eligibility changes  
(   )  Treatment / Dose Modification / Study Calendar changes  
(   )  Informed Consent changes 
(   )  Patient notification not required 
(   ) 
Patient notification required  
(   )  Scientific / Statistical Consideration changes 
(   )  Specimen Submission changes 
(   )  Data Submission / Forms changes  
(   )  Editorial / Administrative changes 
(   )  Other: 
 
 
MEMORANDUM 
 
The purpose of this memorandum is to clarify an error noted in protocol Section 11.8 
Toxicity Monitoring. The first paragraph of Section 11.8 (excerpted below for ease of 
reference) currently indicates, “With 72 patients per treatment arm.” This statement is 
incorrect and will be modified in the next revision to the protocol to read “With 63 patients 
per treatment arm,” as is congruent with the protocol design. 
 
“All eligible patients that have initiated treatment will be considered evaluable for 
toxicity analyses. The maximum grade for each toxicity will be recorded for each 
patient, and frequency tables will be reviewed to determine toxicity patterns. With 
72 patients per study arm, the probability of any particular toxicity can be 


 
S1304 
 
Memorandum (contd.) 
 
Page 2 
 
 
 
estimated within ±14% (95% confidence interval). Any toxicity having a true 
occurrence rate of 5% or more within one of the treatment arms is very likely to 
be observed in at least one patient (probability ≥ 96%).” 
 
This memorandum serves to notify the NCI, Alliance, ECOG-ACRIN, and the SWOG 
Statistical Center. 
 
cc: 
PROTOCOL AND INFORMATION OFFICE 
 
 
Destin Carlisle – Alliance 
 
Mary Bonds – ECOG-ACRIN 
 
Becky Fillingham – ECOG-ACRIN 
Elliott Lee – Biologics 
Joe Connell – Amgen 
 


 
 
 
 
 
 
June 1, 2016 
 
TO: 
ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS; CTSU 
 
FROM: 
Cara Laubach, MIIM, Protocol Coordinator (E-mail:  claubach@swog.org) 
 
RE: 
S1304, “A Phase II Randomized Study Comparing Two Doses of Carfilzomib 
(NSC-756640) with Dexamethasone for Multiple Myeloma Patients with 
Relapsed or Refractory Disease”.  Study Chairs:  Drs. S. Ailawadhi, M.H. 
Abidi, S. Lentzsch, R.Z. Orlowski and E.M. Rohren. 
 
MEMORANDUM 
 
Study Chair:  Sikander A. Ailawadhi 
Phone number: 904/953-7290 
E-mail: S1304SC@swog.org 
 
IRB Review Requirements 
(   ) 
Full board review required    
(   ) 
Expedited review allowed 
(  ) No review required  
 
Status Change 
 
(   )  IRB Review only 
 
(   )  Activation 
(   )  Closure: Permanent 
(   )  Reactivation 
 
Protocol changes 
(   )  Eligibility changes  
(   )  Treatment / Dose Modification / Study Calendar changes  
(   )  Informed Consent changes 
(   )  Patient notification not required 
(   ) 
Patient notification required  
(   )  Scientific / Statistical Consideration changes 
(   )  Specimen Submission changes 
(   )  Data Submission / Forms changes  
(   )  Editorial / Administrative changes 
(   )  Other: 
 
 
MEMORANDUM 
 
As stated in the Activation Memorandum distributed November 1, 2013, ECHO results 
were to be submitted for central review after funding and logistical details had been 
finalized.  At this time, details have been finalized and ECHOs must be submitted.  
Please follow the instructions in Sections 15.3 and 18.2 of the protocol, and submit 
ECHO images for all patients at your earliest convenience. 
 
This memorandum serves to notify the NCI, Alliance, ECOG-ACRIN, and the SWOG 
Statistical Center. 
 
cc: 
PROTOCOL AND INFORMATION OFFICE 
Becky Fillingham – ECOG-ACRIN 
 
Destin Carlisle – Alliance 
Elliott Lee – Biologics 
Mary Bonds – ECOG-ACRIN 
Joe Connell - Amgen 


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