Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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 ( US NIH Grant/Contract Award Number )
MC058E ( Other Identifier: Mayo Clinic Cancer Center )
06-002786 ( Other Identifier: Mayo Clinic IRB )
RV-MM-PI-0116 ( Other Identifier: Celgene Protocol )
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