Trial Outcomes & Findings for Lenalidomide and Vaccine Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma (NCT NCT00445484)
NCT ID: NCT00445484
Last Updated: 2015-08-24
Results Overview
Serum IgG levels against the PVC serotype were measured by ELISA
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
basline and 8 weeks after second vaccination
Results posted on
2015-08-24
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
7
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lenalidomide and Vaccine Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Group 1
n=11 Participants
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
n=11 Participants
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
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 9.0 • n=99 Participants
|
65.8 years
STANDARD_DEVIATION 10.3 • n=107 Participants
|
66.0 years
STANDARD_DEVIATION 9.5 • n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
11 participants
n=107 Participants
|
22 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: basline and 8 weeks after second vaccinationPopulation: Patients who showed evidence of disease progression while on study were not included in the analysis.
Serum IgG levels against the PVC serotype were measured by ELISA
Outcome measures
| Measure |
Vaccine Started 14 Days Prior to Lenalidomide
n=8 Participants
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
|
Vaccine Started 45 Days After Lenalidomide
n=5 Participants
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
|
|---|---|---|
|
6B Antibody Response to Prevnar Vaccine in Peripheral Blood
|
3.69 fold change
Standard Error 1.1
|
7.58 fold change
Standard Error 3.0
|
PRIMARY outcome
Timeframe: basline and 8 weeks after second vaccinationPopulation: Patients who showed evidence of disease progression while on study were not included in the analysis.
Serum IgG levels against the PVC serotype were measured by ELISA
Outcome measures
| Measure |
Vaccine Started 14 Days Prior to Lenalidomide
n=5 Participants
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
|
Vaccine Started 45 Days After Lenalidomide
n=8 Participants
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
|
|---|---|---|
|
14F Antibody Response to Prevnar Vaccine in Peripheral Blood
|
9.42 fold change
Standard Error 5.0
|
11.95 fold change
Standard Error 3.8
|
PRIMARY outcome
Timeframe: basline and 8 weeks after second vaccinationPopulation: Patients who showed evidence of disease progression while on study were not included in the analysis.
Serum IgG levels against the PVC serotype were measured by ELISA
Outcome measures
| Measure |
Vaccine Started 14 Days Prior to Lenalidomide
n=8 Participants
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
|
Vaccine Started 45 Days After Lenalidomide
n=5 Participants
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
|
|---|---|---|
|
19F Antibody Response to Prevnar Vaccine in Peripheral Blood
|
2.025 fold change
Standard Error 0.64
|
2.12 fold change
Standard Error 0.4
|
PRIMARY outcome
Timeframe: basline and 8 weeks after second vaccinationPopulation: Patients who showed evidence of disease progression while on study were not included in the analysis.
Serum IgG levels against the PVC serotype were measured by ELISA
Outcome measures
| Measure |
Vaccine Started 14 Days Prior to Lenalidomide
n=8 Participants
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
|
Vaccine Started 45 Days After Lenalidomide
n=5 Participants
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
|
|---|---|---|
|
23F Antibody Response to Prevnar Vaccine in Peripheral Blood
|
4.1 fold change
Standard Error 1.8
|
2.42 fold change
Standard Error 1
|
Adverse Events
Group 1
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=11 participants at risk
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
n=11 participants at risk
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
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
Other adverse events
| Measure |
Group 1
n=11 participants at risk
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
n=11 participants at risk
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
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Blood and lymphatic system disorders
Anemia
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath on exertion
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Renal and urinary disorders
Renal insufficiency
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Cardiac disorders
Hypertension
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
Additional Information
Dr. Ivan Borrello
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: (410) 955-4967
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place