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Lenalidomide and Vaccine Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00445484
First received: March 7, 2007
Last updated: August 5, 2015
Last verified: August 2015
Results First Received: June 26, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma and Plasma Cell Neoplasm
Interventions: Biological: pneumococcal polyvalent vaccine
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
No text entered.

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
Group 2

Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).

pneumococcal polyvalent vaccine: Given intramuscularly

lenalidomide: Given orally

Group 1

Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).

pneumococcal polyvalent vaccine: Given intramuscularly

lenalidomide: Given orally


Participant Flow:   Overall Study
    Group 2     Group 1  
STARTED     11     11  
COMPLETED     7     10  
NOT COMPLETED     4     1  



  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.
A total of 22 patients were enrolled, 11 in each cohort. Patients who showed evidence of disease progression while on study were not included in subsequent analysis.

Reporting Groups
  Description
Group 1

Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).

pneumococcal polyvalent vaccine: Given intramuscularly

lenalidomide: Given orally

Group 2

Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).

pneumococcal polyvalent vaccine: Given intramuscularly

lenalidomide: Given orally

Total Total of all reporting groups

Baseline Measures
    Group 1     Group 2     Total  
Number of Participants  
[units: participants]
  11     11     22  
Age  
[units: years]
Mean (Standard Deviation)
  66.3  (9.0)     65.8  (10.3)     66.0  (9.5)  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     5     6     11  
>=65 years     6     5     11  
Gender  
[units: participants]
     
Female     7     4     11  
Male     4     7     11  
Region of Enrollment  
[units: participants]
     
United States     11     11     22  



  Outcome Measures
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1.  Primary:   6B Antibody Response to Prevnar Vaccine in Peripheral Blood   [ Time Frame: basline and 8 weeks after second vaccination ]

2.  Primary:   14F Antibody Response to Prevnar Vaccine in Peripheral Blood   [ Time Frame: basline and 8 weeks after second vaccination ]

3.  Primary:   19F Antibody Response to Prevnar Vaccine in Peripheral Blood   [ Time Frame: basline and 8 weeks after second vaccination ]

4.  Primary:   23F Antibody Response to Prevnar Vaccine in Peripheral Blood   [ Time Frame: basline and 8 weeks after second vaccination ]


  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
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  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. Ivan Borrello
Organization: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
phone: (410) 955-4967
e-mail: iborrell@jhmi.edu


Publications of Results:

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00445484     History of Changes
Other Study ID Numbers: J06102 CDR0000532944
P30CA006973 ( US NIH Grant/Contract Award Number )
JHOC-J06102
JHOC-NA_00006008
CELGENE-CC-5013
Study First Received: March 7, 2007
Results First Received: June 26, 2015
Last Updated: August 5, 2015
Health Authority: United States: Federal Government