Continuous Versus Intermittent Dosing Regimens for Pomalidomide in Relapsed/Refractory Multiple Myeloma

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01319422
First received: March 14, 2011
Last updated: June 29, 2016
Last verified: June 2016
Results First Received: May 9, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Intervention: Drug: Pomalidomide

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment took place at an academic medical center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Four screened subjects did not meet eligibility criteria. Forty subjects were enrolled, but one withdrew after randomization without receiving treatment, and is listed as a "non-completer". Thus, data are presented for 39 participants.

Reporting Groups
  Description
Pomalidomide 2 mg/d on 28 Days/28 Day Cycle Pomalidomide: Comparison of different dosages and schedules of drug
Pomalidomide 4 mg/d on 21 Days/28 Day Cycle Pomalidomide: Comparison of different dosages and schedules of drug

Participant Flow:   Overall Study
    Pomalidomide 2 mg/d on 28 Days/28 Day Cycle     Pomalidomide 4 mg/d on 21 Days/28 Day Cycle  
STARTED     20     20  
COMPLETED     19     20  
NOT COMPLETED     1     0  
Withdrawal by Subject                 1                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pomalidomide 2 mg/d on 28 Days/28 Day Cycle Pomalidomide: Comparison of different dosages and schedules of drug
Pomalidomide 4 mg/d on 21 Days/28 Day Cycle Pomalidomide: Comparison of different dosages and schedules of drug
Total Total of all reporting groups

Baseline Measures
    Pomalidomide 2 mg/d on 28 Days/28 Day Cycle     Pomalidomide 4 mg/d on 21 Days/28 Day Cycle     Total  
Number of Participants  
[units: participants]
  19     20     39  
Age  
[units: years]
Median (Full Range)
  63  
  (44 to 87)  
  61  
  (47 to 80)  
  61  
  (44 to 87)  
Gender  
[units: participants]
     
Female     9     8     17  
Male     10     12     22  
Immunoglobulin Heavy chain (IgH) type  
[units: participants]
     
Immunoglobulin G (IgG)     8     12     20  
Immunoglobulin A (IgA)     4     1     5  
Light chain only     7     7     14  
Immunoglobulin Light chain (IgL) type  
[units: participants]
     
kappa     13     15     28  
lambda     6     5     11  
serum beta 2 microglobulin  
[units: mg/L]
Mean (Full Range)
  3.0  
  (1.55 to 5.12)  
  3.4  
  (2.09 to 8.36)  
  3.2  
  (1.55 to 8.36)  
serum albumin  
[units: g/dL]
Mean (Full Range)
  3.9  
  (3.2 to 5.0)  
  3.9  
  (3.2 to 4.8)  
  3.9  
  (3.2 to 5.0)  
lines of prior therapy  
[units: lines]
Median (Full Range)
  4  
  (2 to 7)  
  4  
  (2 to 9)  
  4  
  (2 to 9)  
Deletion of chromosome 17p  
[units: participants]
     
yes     4     3     7  
no     10     9     19  
missing     5     8     13  
Chromosome 1q abnormalities  
[units: participants]
     
yes     10     8     18  
no     9     12     21  
Deletion chromosome 13 [1]
[units: participants]
     
yes     5     8     13  
no     14     12     26  
Lenalidomide (Len) as most recent therapy  
[units: participants]
     
yes     6     9     15  
no     13     11     24  
Resistance to prior therapy-Len refractory  
[units: participants]
     
yes     19     20     39  
no     0     0     0  
Resistance to prior therapy-Len+bortezomib refractory  
[units: participants]
     
yes     15     16     31  
no     4     4     8  
[1] Monosomy 13 on molecular cytogenics or deletion of 13q on fluorescence in situ hybridization (FISH) cytogenics



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Response, Analyzed Per International Myeloma Working Group Response Criteria   [ Time Frame: Efficacy assessments will be made after the first two cycles of therapy (approximately 56 days--each cycle is 28 days) ]

2.  Primary:   Percentage of Participants With Response, Analyzed Per International Myeloma Working Group Response Criteria   [ Time Frame: After the initial efficacy assessment at the completion of cycle 2 (at approximately 56 days), efficacy assessments will be made after every other cycle (approximately every 56 days). ]

3.  Secondary:   To Compare the Effect of Continuous Versus Intermittent Regimens on F Actin Polymerization in Peripheral Blood Mononuclear Cells and Activation of Tumor Antigen-specific T Cells, as Well as Innate Lymphocytes (Natural Killer or Natural Killer T Cells).   [ Time Frame: Research blood draw will be obtained at baseline, and at 2-4 hr (on day 1), 1 wk, and 4 wk after initiation of cycles 1 and 2. ]

4.  Secondary:   To Correlate Drug Induced Changes in F Actin Polymerization With Adverse Effects and Clinical Responses.   [ Time Frame: Research bone marrow aspirate is obtained at baseline and after completion of 2 cycles of therapy (approximately 56 days) ]

5.  Secondary:   To Correlate Drug Induced Changes in F Actin With Cytokine Profile.   [ Time Frame: Research blood draw will be obtained at baseline, and at 2-4 hr (on day 1), 1 wk, and 4 wk after initiation of cycles 1 and 2. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Madhav Dhodapkar, M.D.
Organization: Yale University
phone: 203-785-4144
e-mail: madhav.dhodapkar@yale.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01319422     History of Changes
Other Study ID Numbers: HIC 1011007607
Study First Received: March 14, 2011
Results First Received: May 9, 2016
Last Updated: June 29, 2016
Health Authority: United States: Food and Drug Administration