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Trial record 17 of 2570 for:    "Plasma Cell Neoplasm"

Lenalidomide and Vaccine Therapy in Treating Patients With Relapsed or 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: NCT00445484
Recruitment Status : Completed
First Posted : March 9, 2007
Results First Posted : July 24, 2015
Last Update Posted : August 24, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma and Plasma Cell Neoplasm
Interventions Biological: pneumococcal polyvalent vaccine
Drug: lenalidomide
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 2 Group 1
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 11 11
Completed 7 10
Not Completed 4 1
Arm/Group Title Group 1 Group 2 Total
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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

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 of all reporting groups
Overall Number of Baseline Participants 11 11 22
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 11 participants 22 participants
66.3  (9.0) 65.8  (10.3) 66.0  (9.5)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  45.5%
6
  54.5%
11
  50.0%
>=65 years
6
  54.5%
5
  45.5%
11
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
Female
7
  63.6%
4
  36.4%
11
  50.0%
Male
4
  36.4%
7
  63.6%
11
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 11 participants 22 participants
11 11 22
1.Primary Outcome
Title 6B Antibody Response to Prevnar Vaccine in Peripheral Blood
Hide Description Serum IgG levels against the PVC serotype were measured by ELISA
Time Frame basline and 8 weeks after second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who showed evidence of disease progression while on study were not included in the analysis.
Arm/Group Title Vaccine Started 14 Days Prior to Lenalidomide Vaccine Started 45 Days After Lenalidomide
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 8 5
Mean (Standard Error)
Unit of Measure: fold change
3.69  (1.1) 7.58  (3.0)
2.Primary Outcome
Title 14F Antibody Response to Prevnar Vaccine in Peripheral Blood
Hide Description Serum IgG levels against the PVC serotype were measured by ELISA
Time Frame basline and 8 weeks after second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who showed evidence of disease progression while on study were not included in the analysis.
Arm/Group Title Vaccine Started 14 Days Prior to Lenalidomide Vaccine Started 45 Days After Lenalidomide
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 5 8
Mean (Standard Error)
Unit of Measure: fold change
9.42  (5.0) 11.95  (3.8)
3.Primary Outcome
Title 19F Antibody Response to Prevnar Vaccine in Peripheral Blood
Hide Description Serum IgG levels against the PVC serotype were measured by ELISA
Time Frame basline and 8 weeks after second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who showed evidence of disease progression while on study were not included in the analysis.
Arm/Group Title Vaccine Started 14 Days Prior to Lenalidomide Vaccine Started 45 Days After Lenalidomide
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 8 5
Mean (Standard Error)
Unit of Measure: fold change
2.025  (0.64) 2.12  (0.4)
4.Primary Outcome
Title 23F Antibody Response to Prevnar Vaccine in Peripheral Blood
Hide Description Serum IgG levels against the PVC serotype were measured by ELISA
Time Frame basline and 8 weeks after second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who showed evidence of disease progression while on study were not included in the analysis.
Arm/Group Title Vaccine Started 14 Days Prior to Lenalidomide Vaccine Started 45 Days After Lenalidomide
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 8 5
Mean (Standard Error)
Unit of Measure: fold change
4.1  (1.8) 2.42  (1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description

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

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

All-Cause Mortality
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/11 (9.09%)      0/11 (0.00%)    
Blood and lymphatic system disorders     
Thrombocytopenia  1/11 (9.09%)  1 0/11 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1 Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/11 (9.09%)      1/11 (9.09%)    
Blood and lymphatic system disorders     
Anemia  1/11 (9.09%)  1 0/11 (0.00%)  0
Cardiac disorders     
Hypertension  0/11 (0.00%)  0 1/11 (9.09%)  1
Metabolism and nutrition disorders     
Hyperlipidemia  0/11 (0.00%)  0 1/11 (9.09%)  1
Musculoskeletal and connective tissue disorders     
Lower back pain  1/11 (9.09%)  1 0/11 (0.00%)  0
Renal and urinary disorders     
Renal insufficiency  0/11 (0.00%)  0 1/11 (9.09%)  1
Respiratory, thoracic and mediastinal disorders     
Shortness of breath on exertion  1/11 (9.09%)  1 0/11 (0.00%)  0
Cough  0/11 (0.00%)  0 1/11 (9.09%)  1
Skin and subcutaneous tissue disorders     
Rash  0/11 (0.00%)  0 1/11 (9.09%)  1
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. Ivan Borrello
Organization: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: (410) 955-4967
EMail: iborrell@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00445484     History of Changes
Other Study ID Numbers: J06102 CDR0000532944
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J06102
JHOC-NA_00006008
CELGENE-CC-5013
First Submitted: March 7, 2007
First Posted: March 9, 2007
Results First Submitted: June 26, 2015
Results First Posted: July 24, 2015
Last Update Posted: August 24, 2015