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Trial record 46 of 370 for:    LENALIDOMIDE AND Dexamethasone

Pomalidomide or Lenalidomide and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma Previously Treated With Lenalidomide

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ClinicalTrials.gov Identifier: NCT01794039
Recruitment Status : Completed
First Posted : February 18, 2013
Results First Posted : August 21, 2018
Last Update Posted : August 21, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Plasma Cell Myeloma
Refractory Plasma Cell Myeloma
Interventions Drug: Dexamethasone
Drug: Lenalidomide
Drug: Pomalidomide
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm A (Lenalidomide, Dexamethasone) Arm B (Pomalidomide, Dexamethasone)
Hide Arm/Group Description

Patients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may crossover to arm B. > > Dexamethasone: Given PO >

> Lenalidomide: Given PO

Patients receive pomalidomide PO daily on days 1-21 and dexamethasone as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. > > Dexamethasone: Given PO >

> Pomalidomide: Given PO

Period Title: Overall Study
Started 5 4
Completed 5 4
Not Completed 0 0
Arm/Group Title Arm A (Lenalidomide, Dexamethasone) Arm B (Pomalidomide, Dexamethasone) Total
Hide Arm/Group Description

Patients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may crossover to arm B. > > Dexamethasone: Given PO >

> Lenalidomide: Given PO

Patients receive pomalidomide PO daily on days 1-21 and dexamethasone as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. > > Dexamethasone: Given PO >

> Pomalidomide: Given PO

Total of all reporting groups
Overall Number of Baseline Participants 5 4 9
Hide Baseline Analysis Population Description
All Enrolled Patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants 4 participants 9 participants
67
(64 to 75)
68.5
(60 to 72)
67
(60 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
Female
2
  40.0%
1
  25.0%
3
  33.3%
Male
3
  60.0%
3
  75.0%
6
  66.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
5
 100.0%
4
 100.0%
9
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Proportion of Confirmed Tumor Responses Defined to be a Partial Response or Better Noted as the Objective Status on Two Consecutive Evaluations
Hide Description The proportion of successes will be estimated in each arm independently by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. A confirmed tumor response is defined to be a partial response or better noted as the objective status on two consecutive evaluations while receiving lenalidomide and dexmethasone (Arm A) or pomalidomide and dexamethasone (Arm B). All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.The International Myeloma Working Group (IMWG) uniform response criteria (Rajkumar et al, 2011) will be used to assess response to therapy.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that received treatment were evaluable for response
Arm/Group Title Arm A (Lenalidomide, Dexamethasone) Arm B (Pomalidomide, Dexamethasone)
Hide Arm/Group Description:

Patients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may crossover to arm B.

>

> Dexamethasone: Given PO

>

> Lenalidomide: Given PO

Patients receive pomalidomide PO daily on days 1-21 and dexamethasone as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

>

> Dexamethasone: Given PO

>

> Pomalidomide: Given PO

Overall Number of Participants Analyzed 5 4
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
.4
(.05 to .85)
.25
(.006 to .81)
2.Secondary Outcome
Title Number of Participants With Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hide Description Recorded and reported for each patient, and frequency tables will be reviewed to determine adverse event patterns. These results are reported in the Adverse Events section of this CT.gov report.
Time Frame Up to 30 days after last day of study drug treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients are evaluable for Adverse Events
Arm/Group Title Arm A (Lenalidomide, Dexamethasone) Arm B (Pomalidomide, Dexamethasone)
Hide Arm/Group Description:

Patients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may crossover to arm B.

>

> Dexamethasone: Given PO

>

> Lenalidomide: Given PO

Patients receive pomalidomide PO daily on days 1-21 and dexamethasone as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

>

> Dexamethasone: Given PO

>

> Pomalidomide: Given PO

Overall Number of Participants Analyzed 5 4
Measure Type: Count of Participants
Unit of Measure: Participants
5
 100.0%
4
 100.0%
3.Secondary Outcome
Title Overall Survival
Hide Description The distribution of survival time will be estimated using the method of Kaplan-Meier. Due to an early closer from slow accrual the data from both arms was combined in survival analysis.
Time Frame Time from registration to death due to any cause, assessed up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that received Arm A or Arm B treatment.
Arm/Group Title Arms A and B
Hide Arm/Group Description:
4 arm A patients were transferred to Arm B for further treatment. Arm A patients, that went off study for any reason, were allowed to transfer to Arm B.
Overall Number of Participants Analyzed 9
Median (95% Confidence Interval)
Unit of Measure: Months
13.4 [1] 
(9.3 to NA)
[1]
Upper confidence interval was not reached
4.Secondary Outcome
Title Time to Progression
Hide Description The distribution of time to progression will be estimated using the method of Kaplan-Meier. The International Myeloma Working Group (IMWG) uniform response criteria (Rajkumar et al, 2011) will be used to assess response to therapy.
Time Frame Time from registration to the earliest date with documentation of disease progression, assessed up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that received Arm A or Arm B treatment.
Arm/Group Title Arms A and B
Hide Arm/Group Description:
4 arm A patients were transferred to Arm B for further treatment. Arm A patients, that went off study for any reason, were allowed to transfer to Arm B
Overall Number of Participants Analyzed 9
Median (95% Confidence Interval)
Unit of Measure: Months
10
(4.1 to 12.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A (Lenalidomide, Dexamethasone) Arm B (Pomalidomide, Dexamethasone)
Hide Arm/Group Description Lenalidomide: Given PO Pomalidomide: Given PO
All-Cause Mortality
Arm A (Lenalidomide, Dexamethasone) Arm B (Pomalidomide, Dexamethasone)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm A (Lenalidomide, Dexamethasone) Arm B (Pomalidomide, Dexamethasone)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/5 (60.00%)      2/4 (50.00%)    
Blood and lymphatic system disorders     
Anemia  1  0/5 (0.00%)  0 1/4 (25.00%)  1
Febrile neutropenia  1  0/5 (0.00%)  0 1/4 (25.00%)  1
Cardiac disorders     
Acute coronary syndrome  1  1/5 (20.00%)  1 0/4 (0.00%)  0
Atrial fibrillation  1  0/5 (0.00%)  0 1/4 (25.00%)  1
Infections and infestations     
Lung infection  1  2/5 (40.00%)  2 1/4 (25.00%)  1
Sepsis  1  0/5 (0.00%)  0 1/4 (25.00%)  2
Upper respiratory infection  1  0/5 (0.00%)  0 1/4 (25.00%)  1
Investigations     
Lymphocyte count decreased  1  1/5 (20.00%)  1 0/4 (0.00%)  0
Neutrophil count decreased  1  1/5 (20.00%)  1 0/4 (0.00%)  0
Platelet count decreased  1  1/5 (20.00%)  1 0/4 (0.00%)  0
White blood cell decreased  1  1/5 (20.00%)  1 0/4 (0.00%)  0
Metabolism and nutrition disorders     
Hyperglycemia  1  1/5 (20.00%)  1 0/4 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  0/5 (0.00%)  0 1/4 (25.00%)  1
Vascular disorders     
Thromboembolic event  1  1/5 (20.00%)  1 0/4 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A (Lenalidomide, Dexamethasone) Arm B (Pomalidomide, Dexamethasone)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/5 (100.00%)      4/4 (100.00%)    
Blood and lymphatic system disorders     
Anemia  1  2/5 (40.00%)  5 1/4 (25.00%)  2
Cardiac disorders     
Aortic valve disease  1  0/5 (0.00%)  0 1/4 (25.00%)  1
Gastrointestinal disorders     
Constipation  1  1/5 (20.00%)  5 2/4 (50.00%)  4
Diarrhea  1  4/5 (80.00%)  23 2/4 (50.00%)  5
Nausea  1  0/5 (0.00%)  0 1/4 (25.00%)  1
General disorders     
Edema limbs  1  2/5 (40.00%)  4 2/4 (50.00%)  5
Fatigue  1  5/5 (100.00%)  36 3/4 (75.00%)  15
Infections and infestations     
Infections and infestations - Oth spec  1  1/5 (20.00%)  1 0/4 (0.00%)  0
Investigations     
Lymphocyte count decreased  1  4/5 (80.00%)  25 2/4 (50.00%)  2
Neutrophil count decreased  1  5/5 (100.00%)  18 2/4 (50.00%)  7
Platelet count decreased  1  4/5 (80.00%)  30 2/4 (50.00%)  7
White blood cell decreased  1  5/5 (100.00%)  24 3/4 (75.00%)  8
Metabolism and nutrition disorders     
Hyperglycemia  1  0/5 (0.00%)  0 1/4 (25.00%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  0/5 (0.00%)  0 1/4 (25.00%)  1
Myalgia  1  1/5 (20.00%)  2 0/4 (0.00%)  0
Nervous system disorders     
Peripheral sensory neuropathy  1  5/5 (100.00%)  46 3/4 (75.00%)  15
Tremor  1  0/5 (0.00%)  0 1/4 (25.00%)  9
Psychiatric disorders     
Agitation  1  1/5 (20.00%)  5 0/4 (0.00%)  0
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  1/5 (20.00%)  2 0/4 (0.00%)  0
Hypohidrosis  1  1/5 (20.00%)  3 0/4 (0.00%)  0
Rash maculo-papular  1  1/5 (20.00%)  2 1/4 (25.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Shaji K. Kumar, M.D.
Organization: Mayo Clinic
Phone: (507) 284-2017
EMail: kumar.shaji@mayo.edu
Layout table for additonal information
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01794039     History of Changes
Other Study ID Numbers: MC1187
NCI-2013-00412 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
12-006426
MCCC Add 1
MC1187 ( Other Identifier: Mayo Clinic )
P30CA015083 ( U.S. NIH Grant/Contract )
First Submitted: February 14, 2013
First Posted: February 18, 2013
Results First Submitted: May 14, 2018
Results First Posted: August 21, 2018
Last Update Posted: August 21, 2018