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Trial record 10 of 2571 for:    "Plasma Cell Neoplasm"

Lenalidomide With or Without Dexamethasone in Treating Patients With Newly Diagnosed 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: NCT00772915
Recruitment Status : Completed
First Posted : October 15, 2008
Results First Posted : August 8, 2012
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma and Plasma Cell Neoplasm
Interventions Drug: dexamethasone
Drug: lenalidomide
Enrollment 39
Recruitment Details Thirty-nine (39) participants were recruited at Mayo Clinic (Rochester) between December 2008 and April 2010.
Pre-assignment Details One participant canceled prior to starting treatment; this participant has been removed from all analyses.
Arm/Group Title Lenalidomide With On-Demand Dexamethasone
Hide Arm/Group Description

Lenalidmoide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles. >

> Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression.

Period Title: Overall Study
Started 38
Completed 23
Not Completed 15
Arm/Group Title Lenalidomide With On-Demand Dexamethasone
Hide Arm/Group Description

Lenalidmoide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles. >

> Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression.

Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 38 participants
66
(45 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
21
  55.3%
Male
17
  44.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 38 participants
38
Durie Salmon Stage at Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants
Stage I: Low Cell Mass 8
Stage II: Intermediate Cell Mass 15
Stage III: High Cell Mass 12
Not Assessed 3
Parameter of Hematologic Response: Serum M-Spike >= 1 mg/dL  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants
Yes 26
No 12
Parameter of Hematologic Response: Serum Immunoglobulin Free Light Chain >= 10 mg/dL  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants
Yes 25
No 13
Parameter of Hematologic Response: Urine M-Spike >= 200 mg/24 hours  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants
Yes 14
No 24
1.Primary Outcome
Title Progression-free Survival Rate at 12 Months
Hide Description PFS at 12 months is a dichotomized outcome indicating whether or not a participant was progression free (and alive) at 12 months from the date of registration.
Time Frame 12 months from registration
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide With On-Demand Dexamethasone
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Lenalidmoide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles.

Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression.

Overall Number of Participants Analyzed 38
Measure Type: Number
Unit of Measure: participants
14
2.Secondary Outcome
Title Overall Response Rate
Hide Description

Response that was confirmed on 2 consecutive evaluations during treatment

  • Complete Response(CR): Complete disappearance of M-protein from serum & urine on immunofixation, normalization of Free Light Chain (FLC) ratio & <5% plasma cells in bone marrow (BM)
  • Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM
  • Partial Response PR): >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels
Time Frame Up to 18 cycles from registration
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 3 years from randomization. The median OS with 95% CI was estimated using the Kaplan Meier method
Time Frame Time from registration to death (up to 3 years)
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description

PFS was defined as the time from registration to progression or death due to any cause. The median PFS with 95%CI was estimated using the Kaplan Meier method.

Progression was defined as any one or more of the following:An increase of 25% from lowest confirmed response in:

  • Serum M-component (absolute increase >= 0.5g/dl)
  • Urine M-component (absolute increase >= 200mg/24hour
  • Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl
  • Bone marrow plasma cell percentage (absolute increase of >=10%)
Time Frame Time from registration to progression or death (up to 3 years)
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Adverse Events
Hide Description [Not Specified]
Time Frame Duration on treatment (up to 18 cycles from registration)
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide With On-Demand Dexamethasone
Hide Arm/Group Description Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression.
All-Cause Mortality
Lenalidomide With On-Demand Dexamethasone
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide With On-Demand Dexamethasone
Affected / at Risk (%) # Events
Total   9/38 (23.68%)    
Cardiac disorders   
Left ventricular failure  1  1/38 (2.63%)  1
Gastrointestinal disorders   
Dysphagia  1  1/38 (2.63%)  1
General disorders   
Chills  1  1/38 (2.63%)  1
Fatigue  1  1/38 (2.63%)  1
Infections and infestations   
Meningitis  1  1/38 (2.63%)  1
Pneumonia  1  1/38 (2.63%)  1
Sepsis  1  1/38 (2.63%)  1
Injury, poisoning and procedural complications   
Fracture  1  1/38 (2.63%)  1
Intraoperative musculoskeletal injury  1  1/38 (2.63%)  1
Investigations   
Neutrophil count decreased  1  1/38 (2.63%)  1
Renal and urinary disorders   
Renal Failure  1  1/38 (2.63%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumothorax  1  1/38 (2.63%)  1
Vascular disorders   
Thrombosis  1  2/38 (5.26%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lenalidomide With On-Demand Dexamethasone
Affected / at Risk (%) # Events
Total   38/38 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  36/38 (94.74%)  311
Eye disorders   
Cataract  1  1/38 (2.63%)  2
Gastrointestinal disorders   
Colitis  1  1/38 (2.63%)  1
Constipation  1  3/38 (7.89%)  9
Diarrhea  1  3/38 (7.89%)  4
Gastrointestinal  1  1/38 (2.63%)  1
Mucositis oral  1  1/38 (2.63%)  1
Nausea  1  1/38 (2.63%)  2
General disorders   
Fatigue  1  34/38 (89.47%)  258
Pain  1  1/38 (2.63%)  1
Pain-Chest  1  2/38 (5.26%)  2
Infections and infestations   
Gallbladder (cholecystitis) infection  1  1/38 (2.63%)  1
Infection without neutropenia  1  1/38 (2.63%)  1
Pneumonia  1  1/38 (2.63%)  2
Skin (cellulites) infection  1  2/38 (5.26%)  2
Upper airway infection  1  3/38 (7.89%)  5
Injury, poisoning and procedural complications   
Fracture  1  1/38 (2.63%)  1
Investigations   
Alanine aminotransferase increased  1  1/38 (2.63%)  1
Aspartate aminotransferase increased  1  1/38 (2.63%)  3
Bilirubin  1  2/38 (5.26%)  4
Creatinine increased  1  1/38 (2.63%)  1
Leukopenia  1  33/38 (86.84%)  174
Lymphocyte count decreased  1  3/38 (7.89%)  12
Neutrophil count decreased  1  31/38 (81.58%)  171
Platelet count decreased  1  19/38 (50.00%)  108
Weight gain  1  1/38 (2.63%)  1
Metabolism and nutrition disorders   
Dehydration  1  1/38 (2.63%)  1
Hypercalcemia  1  1/38 (2.63%)  1
Hyperglycemia  1  4/38 (10.53%)  8
Hypocalcemia  1  1/38 (2.63%)  1
Hypoglycemia  1  2/38 (5.26%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/38 (2.63%)  4
Back pain  1  2/38 (5.26%)  3
Bone pain  1  1/38 (2.63%)  1
Neck pain  1  1/38 (2.63%)  1
Nervous system disorders   
Peripheral sensory neuropathy  1  23/38 (60.53%)  150
Syncope  1  1/38 (2.63%)  1
Tremor  1  1/38 (2.63%)  3
Psychiatric disorders   
Depression  1  1/38 (2.63%)  8
Insomnia  1  3/38 (7.89%)  3
Renal and urinary disorders   
Renal Failure  1  1/38 (2.63%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/38 (2.63%)  1
Pleural effusion  1  1/38 (2.63%)  1
Skin and subcutaneous tissue disorders   
Erythema multiforme  1  1/38 (2.63%)  1
Pruritus  1  1/38 (2.63%)  1
Rash  1  3/38 (7.89%)  3
Vascular disorders   
Hot flashes  1  1/38 (2.63%)  2
Phlebitis  1  1/38 (2.63%)  1
Thrombosis  1  1/38 (2.63%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
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: Dr. Shaji Kumar
Organization: Mayo Clinic
EMail: kumar.shaji@mayo.edu
Layout table for additonal information
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00772915     History of Changes
Other Study ID Numbers: CDR0000616057
P30CA015083 ( U.S. NIH Grant/Contract )
MC0884 ( Other Identifier: Mayo Clinic Cancer Center )
08-002093 ( Other Identifier: Mayo Clinic IRB )
NCI-2009-01201 ( Registry Identifier: NCI CTRP )
RV-MM-PI-367 ( Other Identifier: Celgene Protocol )
First Submitted: October 12, 2008
First Posted: October 15, 2008
Results First Submitted: June 26, 2012
Results First Posted: August 8, 2012
Last Update Posted: July 24, 2018