Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00478218
First received: May 23, 2007
Last updated: August 29, 2011
Last verified: August 2011
Results First Received: June 30, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma and Plasma Cell Neoplasm
Interventions: Drug: cyclophosphamide
Drug: dexamethasone
Drug: lenalidomide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Fifty-three (53) participants were recruited between July 2006 and August 2008 at Mayo Clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
LCD (Cyclophosphamide 300 mg/m^2) Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
LCD (Cyclophosphamide 300 mg) Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22

Participant Flow:   Overall Study
    LCD (Cyclophosphamide 300 mg/m^2)     LCD (Cyclophosphamide 300 mg)  
STARTED     34     19  
COMPLETED     34     19  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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
LCD (Cyclophosphamide 300 mg/m^2) Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
LCD (Cyclophosphamide 300 mg) Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
Total Total of all reporting groups

Baseline Measures
    LCD (Cyclophosphamide 300 mg/m^2)     LCD (Cyclophosphamide 300 mg)     Total  
Number of Participants  
[units: participants]
  34     19     53  
Age  
[units: years]
Median ( Full Range )
  63.5  
  ( 44 to 79 )  
  65  
  ( 37 to 82 )  
  64  
  ( 37 to 82 )  
Gender  
[units: participants]
     
Female     17     9     26  
Male     17     10     27  
Region of Enrollment  
[units: participants]
     
United States     34     19     53  
Durie Salmon Stage  
[units: paricipants]
     
Stage IA - Low Cell Mass     3     1     4  
Stage IIA - Intermediate Cell Mass     7     11     18  
Stage IIIA/B - High Cell Mass     24     7     31  
Parameter of Hematologic Response - Serum M-spike >= 1 g/dL  
[units: participants]
     
Yes     25     14     39  
No     9     5     14  
Parameter of Hematologic Response - Serum Immunoglobulin Free Light Chain >= 10 mg/dL  
[units: participants]
     
Yes     21     14     35  
No     13     5     18  
Parameter of Hematologic Response - Urine M-Spike >= 200 mg/24 hours  
[units: participants]
     
Yes     11     5     16  
No     23     14     37  
Parameter of Hematologic Response - Bone Marrow Plasma Cells > 30%  
[units: participants]
     
Yes     17     14     31  
No     17     5     22  



  Outcome Measures
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1.  Primary:   Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment   [ Time Frame: Duration of Treatment (up to 5 years) ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: up to 5 years ]

3.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: up to 5 years ]

4.  Secondary:   Duration of Response (DOR)   [ Time Frame: up to 5 years ]


  Serious Adverse Events


  Other Adverse Events


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


Results Point of Contact:  
Name/Title: Dr. Shaji Kumar
Organization: Mayo Clinic
e-mail: kumar.shaji@mayo.edu


Publications of Results:

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00478218     History of Changes
Other Study ID Numbers: CDR0000546657, P30CA015083, MC058E, 06-002786, RV-MM-PI-0116
Study First Received: May 23, 2007
Results First Received: June 30, 2011
Last Updated: August 29, 2011
Health Authority: United States: Food and Drug Administration