Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 17 of 846 for:    LENALIDOMIDE AND Angiogenesis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01319422
Recruitment Status : Completed
First Posted : March 21, 2011
Results First Posted : August 11, 2016
Last Update Posted : August 11, 2016
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Intervention Drug: Pomalidomide
Enrollment 40
Recruitment Details Recruitment took place at an academic medical center.
Pre-assignment Details 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.
Arm/Group Title Pomalidomide 2 mg/d on 28 Days/28 Day Cycle Pomalidomide 4 mg/d on 21 Days/28 Day Cycle
Hide Arm/Group Description Pomalidomide: Comparison of different dosages and schedules of drug Pomalidomide: Comparison of different dosages and schedules of drug
Period Title: Overall Study
Started 20 20
Completed 19 20
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Pomalidomide 2 mg/d on 28 Days/28 Day Cycle Pomalidomide 4 mg/d on 21 Days/28 Day Cycle Total
Hide Arm/Group Description Pomalidomide: Comparison of different dosages and schedules of drug Pomalidomide: Comparison of different dosages and schedules of drug Total of all reporting groups
Overall Number of Baseline Participants 19 20 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 19 participants 20 participants 39 participants
63
(44 to 87)
61
(47 to 80)
61
(44 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
Female
9
  47.4%
8
  40.0%
17
  43.6%
Male
10
  52.6%
12
  60.0%
22
  56.4%
Immunoglobulin Heavy chain (IgH) type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
Immunoglobulin G (IgG) 8 12 20
Immunoglobulin A (IgA) 4 1 5
Light chain only 7 7 14
Immunoglobulin Light chain (IgL) type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
kappa 13 15 28
lambda 6 5 11
serum beta 2 microglobulin  
Mean (Full Range)
Unit of measure:  mg/L
Number Analyzed 19 participants 20 participants 39 participants
3.0
(1.55 to 5.12)
3.4
(2.09 to 8.36)
3.2
(1.55 to 8.36)
serum albumin  
Mean (Full Range)
Unit of measure:  g/dL
Number Analyzed 19 participants 20 participants 39 participants
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  
Median (Full Range)
Unit of measure:  Lines
Number Analyzed 19 participants 20 participants 39 participants
4
(2 to 7)
4
(2 to 9)
4
(2 to 9)
Deletion of chromosome 17p  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
yes 4 3 7
no 10 9 19
missing 5 8 13
Chromosome 1q abnormalities  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
yes 10 8 18
no 9 12 21
Deletion chromosome 13   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
yes 5 8 13
no 14 12 26
[1]
Measure Description: Monosomy 13 on molecular cytogenics or deletion of 13q on fluorescence in situ hybridization (FISH) cytogenics
Lenalidomide (Len) as most recent therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
yes 6 9 15
no 13 11 24
Resistance to prior therapy-Len refractory  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
yes 19 20 39
no 0 0 0
Resistance to prior therapy-Len+bortezomib refractory  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
yes 15 16 31
no 4 4 8
1.Primary Outcome
Title Percentage of Participants With Response, Analyzed Per International Myeloma Working Group Response Criteria
Hide Description All partial and complete responses must be confirmed with another efficacy assessment in no less than 4 weeks apart.
Time Frame Efficacy assessments will be made after the first two cycles of therapy (approximately 56 days--each cycle is 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pomalidomide 2 mg/d on 28 Days/28 Day Cycle Pomalidomide 4 mg/d on 21 Days/28 Day Cycle
Hide Arm/Group Description:
Pomalidomide: Comparison of different dosages and schedules of drug
Pomalidomide: Comparison of different dosages and schedules of drug
Overall Number of Participants Analyzed 19 20
Measure Type: Number
Unit of Measure: percentage of participants
15.8 20.0
2.Primary Outcome
Title Percentage of Participants With Response, Analyzed Per International Myeloma Working Group Response Criteria
Hide Description All partial and complete responses must be confirmed with another efficacy assessment in no less than 4 weeks apart.
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).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pomalidomide 2 mg/d on 28 Days/28 Day Cycle Pomalidomide 4 mg/d on 21 Days/28 Day Cycle
Hide Arm/Group Description:
Pomalidomide: Comparison of different dosages and schedules of drug
Pomalidomide: Comparison of different dosages and schedules of drug
Overall Number of Participants Analyzed 19 20
Measure Type: Number
Unit of Measure: percentage of participants
cycle 4 15.8 40.0
cycle 6 21.0 40.0
cycle 8 21.0 45.0
cycle 10 21.0 45.0
cycle 12 21.0 45.0
cycle 14 21.0 45.0
3.Secondary Outcome
Title 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).
Hide Description Correlation to be determined upon completion of study treatment
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.
Hide Outcome Measure Data
Hide Analysis Population Description
N/A: data were not collected on this outcome; initial F actin polymerization assay was unreliable and not reproducible; hence, this outcome could not be pursued.
Arm/Group Title Pomalidomide 2 mg/d on 28 Days/28 Day Cycle Pomalidomide 4 mg/d on 21 Days/28 Day Cycle
Hide Arm/Group Description:
Pomalidomide: Comparison of different dosages and schedules of drug
Pomalidomide: Comparison of different dosages and schedules of drug
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title To Correlate Drug Induced Changes in F Actin Polymerization With Adverse Effects and Clinical Responses.
Hide Description Research bone marrow aspirate is obtained to assess response (optional, but recommended), and to document complete remission, if applicable. Correlation to be determined upon completion of study treatment
Time Frame Research bone marrow aspirate is obtained at baseline and after completion of 2 cycles of therapy (approximately 56 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The actin polymerization assay that was to be used for this outcome was not reproducible and data were not analyzed.
Arm/Group Title Pomalidomide 2 mg/d on 28 Days/28 Day Cycle Pomalidomide 4 mg/d on 21 Days/28 Day Cycle
Hide Arm/Group Description:
Pomalidomide: Comparison of different dosages and schedules of drug
Pomalidomide: Comparison of different dosages and schedules of drug
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title To Correlate Drug Induced Changes in F Actin With Cytokine Profile.
Hide Description Correlation to be determined upon completion of study treatment
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.
Hide Outcome Measure Data
Hide Analysis Population Description
The actin polymerization assay that was to be used for this outcome was not reproducible; hence, the cytokine profile of actin polymerized cells could not be pursued. Data were not analyzed.
Arm/Group Title Pomalidomide 2 mg/d on 28 Days/28 Day Cycle Pomalidomide 4 mg/d on 21 Days/28 Day Cycle
Hide Arm/Group Description:
Pomalidomide: Comparison of different dosages and schedules of drug
Pomalidomide: Comparison of different dosages and schedules of drug
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pomalidomide 4 mg/d on 21 Days/28 Day Cycle Pomalidomide 2 mg/d on 28 Days/28 Day Cycle
Hide Arm/Group Description Pomalidomide: Comparison of different dosages and schedules of drug Pomalidomide: Comparison of different dosages and schedules of drug
All-Cause Mortality
Pomalidomide 4 mg/d on 21 Days/28 Day Cycle Pomalidomide 2 mg/d on 28 Days/28 Day Cycle
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pomalidomide 4 mg/d on 21 Days/28 Day Cycle Pomalidomide 2 mg/d on 28 Days/28 Day Cycle
Affected / at Risk (%) Affected / at Risk (%)
Total   11/20 (55.00%)   7/19 (36.84%) 
Blood and lymphatic system disorders     
Anemia  0/20 (0.00%)  1/19 (5.26%) 
Thrombocytopenia  0/20 (0.00%)  2/19 (10.53%) 
Leukopenia  0/20 (0.00%)  1/19 (5.26%) 
Cardiac disorders     
Syncope  1/20 (5.00%)  1/19 (5.26%) 
Thromboembolic event  1/20 (5.00%)  0/19 (0.00%) 
Cardiac Disorders, other  1/20 (5.00%)  0/19 (0.00%) 
Endocrine disorders     
Hyperglycemia  1/20 (5.00%)  0/19 (0.00%) 
General disorders     
Fever  2/20 (10.00%)  2/19 (10.53%) 
Infections and infestations     
Febrile neutropenia  1/20 (5.00%)  3/19 (15.79%) 
Lung infection  3/20 (15.00%)  2/19 (10.53%) 
Infection (Bacteremia)  1/20 (5.00%)  0/19 (0.00%) 
Upper respiratory infection  1/20 (5.00%)  0/19 (0.00%) 
Infection (Other-Influenza)  1/20 (5.00%)  0/19 (0.00%) 
Skin Infection  1/20 (5.00%)  0/19 (0.00%) 
Musculoskeletal and connective tissue disorders     
Hip Fracture  0/20 (0.00%)  1/19 (5.26%) 
Spinal fracture  0/20 (0.00%)  1/19 (5.26%) 
Back Pain  1/20 (5.00%)  0/19 (0.00%) 
Renal and urinary disorders     
Acute Kidney Injury  1/20 (5.00%)  1/19 (5.26%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea  3/20 (15.00%)  0/19 (0.00%) 
Hypoxia  1/20 (5.00%)  0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pomalidomide 4 mg/d on 21 Days/28 Day Cycle Pomalidomide 2 mg/d on 28 Days/28 Day Cycle
Affected / at Risk (%) Affected / at Risk (%)
Total   20/20 (100.00%)   19/19 (100.00%) 
Blood and lymphatic system disorders     
Anemia  10/20 (50.00%)  6/19 (31.58%) 
Neutropenia  9/20 (45.00%)  5/19 (26.32%) 
Leukopenia  15/20 (75.00%)  12/19 (63.16%) 
Thrombocytopenia  9/20 (45.00%)  6/19 (31.58%) 
Cardiac disorders     
Hypertension  1/20 (5.00%)  1/19 (5.26%) 
Presyncope  1/20 (5.00%)  0/19 (0.00%) 
Endocrine disorders     
TSH increased  0/20 (0.00%)  1/19 (5.26%) 
T3 increased  0/20 (0.00%)  1/19 (5.26%) 
Libido decreased  1/20 (5.00%)  0/19 (0.00%) 
Gastrointestinal disorders     
Constipation  4/20 (20.00%)  2/19 (10.53%) 
Diarrhea  4/20 (20.00%)  5/19 (26.32%) 
GERD  1/20 (5.00%)  0/19 (0.00%) 
General disorders     
Fatigue  12/20 (60.00%)  15/19 (78.95%) 
Nausea  5/20 (25.00%)  4/19 (21.05%) 
Vomiting  2/20 (10.00%)  2/19 (10.53%) 
Edema Limbs  3/20 (15.00%)  2/19 (10.53%) 
Fever  2/20 (10.00%)  2/19 (10.53%) 
Anorexia  5/20 (25.00%)  2/19 (10.53%) 
Pruritus  5/20 (25.00%)  3/19 (15.79%) 
Hot flashes  5/20 (25.00%)  2/19 (10.53%) 
Dizziness  4/20 (20.00%)  2/19 (10.53%) 
Edema  3/20 (15.00%)  0/19 (0.00%) 
Pain in extremity  4/20 (20.00%)  1/19 (5.26%) 
Sore throat  2/20 (10.00%)  0/19 (0.00%) 
Abdominal Pain  1/20 (5.00%)  1/19 (5.26%) 
Dry mouth  1/20 (5.00%)  1/19 (5.26%) 
Weight loss  1/20 (5.00%)  1/19 (5.26%) 
Insomnia  0/20 (0.00%)  1/19 (5.26%) 
Flu-like symptoms  0/20 (0.00%)  1/19 (5.26%) 
Erectile dysfunction  1/20 (5.00%)  0/19 (0.00%) 
Flatulence  1/20 (5.00%)  0/19 (0.00%) 
Nasal congestion  1/20 (5.00%)  0/19 (0.00%) 
Weight gain  1/20 (5.00%)  0/19 (0.00%) 
Pain  1/20 (5.00%)  0/19 (0.00%) 
Hepatobiliary disorders     
AST increased  5/20 (25.00%)  3/19 (15.79%) 
ALT increased  6/20 (30.00%)  2/19 (10.53%) 
Infections and infestations     
Upper respiratory infection  3/20 (15.00%)  0/19 (0.00%) 
Soft tissue infection  2/20 (10.00%)  0/19 (0.00%) 
Lung infection  2/20 (10.00%)  1/19 (5.26%) 
Bronchitis  2/20 (10.00%)  0/19 (0.00%) 
Sinusitis  2/20 (10.00%)  0/19 (0.00%) 
Productive cough  1/20 (5.00%)  0/19 (0.00%) 
Urinary tract infection  0/20 (0.00%)  1/19 (5.26%) 
Periodontal disease  0/20 (0.00%)  1/19 (5.26%) 
Infection (other, oral)  1/20 (5.00%)  0/19 (0.00%) 
Metabolism and nutrition disorders     
Hyponatremia  6/20 (30.00%)  3/19 (15.79%) 
Hypokalemia  2/20 (10.00%)  2/19 (10.53%) 
Hypocalcemia  5/20 (25.00%)  3/19 (15.79%) 
Hyperglycemia  1/20 (5.00%)  1/19 (5.26%) 
Hypomagnesemia  0/20 (0.00%)  1/19 (5.26%) 
Hyperkalemia  1/20 (5.00%)  0/19 (0.00%) 
Musculoskeletal and connective tissue disorders     
Myalgia  5/20 (25.00%)  4/19 (21.05%) 
Generalized muscle weakness  2/20 (10.00%)  1/19 (5.26%) 
Back Pain  1/20 (5.00%)  1/19 (5.26%) 
Back Pain  0/20 (0.00%)  1/19 (5.26%) 
Jaw pain  0/20 (0.00%)  1/19 (5.26%) 
Bone pain  1/20 (5.00%)  0/19 (0.00%) 
Arthralgia  1/20 (5.00%)  0/19 (0.00%) 
Nervous system disorders     
Dysguesia  1/20 (5.00%)  3/19 (15.79%) 
Blurred vision  0/20 (0.00%)  2/19 (10.53%) 
Tremor  4/20 (20.00%)  3/19 (15.79%) 
Headache  4/20 (20.00%)  0/19 (0.00%) 
Memory impairment  2/20 (10.00%)  0/19 (0.00%) 
Neuropathy  3/20 (15.00%)  1/19 (5.26%) 
Confusion  1/20 (5.00%)  1/19 (5.26%) 
Gait disturbance  1/20 (5.00%)  1/19 (5.26%) 
Heightened sense of smell  0/20 (0.00%)  1/19 (5.26%) 
Amnesia  0/20 (0.00%)  1/19 (5.26%) 
Vertigo  0/20 (0.00%)  1/19 (5.26%) 
Muscle weakness, lower limb  1/20 (5.00%)  0/19 (0.00%) 
Psychiatric disorders     
Anxiety  2/20 (10.00%)  0/19 (0.00%) 
Depression  1/20 (5.00%)  0/19 (0.00%) 
Renal and urinary disorders     
Creatinine increased  3/20 (15.00%)  1/19 (5.26%) 
Bladder pain  0/20 (0.00%)  1/19 (5.26%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1/20 (5.00%)  3/19 (15.79%) 
Dyspnea  7/20 (35.00%)  6/19 (31.58%) 
Hoarseness  0/20 (0.00%)  1/19 (5.26%) 
Wheezing  1/20 (5.00%)  0/19 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  5/20 (25.00%)  1/19 (5.26%) 
Erythema  0/20 (0.00%)  1/19 (5.26%) 
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: Madhav Dhodapkar, M.D.
Organization: Yale University
Phone: 203-785-4144
EMail: madhav.dhodapkar@yale.edu
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01319422     History of Changes
Other Study ID Numbers: HIC 1011007607
First Submitted: March 14, 2011
First Posted: March 21, 2011
Results First Submitted: May 9, 2016
Results First Posted: August 11, 2016
Last Update Posted: August 11, 2016