RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Vaccines may help the body build an effective immune response to kill cancer cells. Giving lenalidomide together with vaccine therapy may make a stronger immune response and kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving lenalidomide together with vaccine therapy works in treating patients with relapsed or refractory multiple myeloma.
Primary Outcome Measures:
- Humoral and cellular response [ Designated as safety issue: No ]
- Efficacy of pneumococcal polyvalent vaccine [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes in delayed-type hypersensitivity reactions to Candida and tetanus in the presence of lenalidomide [ Designated as safety issue: No ]
- Immune responses to carrier protein CRM 197 in peripheral blood and bone marrow [ Designated as safety issue: No ]
- Effect of lenalidomide on T-cell activation in blood and bone marrow [ Designated as safety issue: No ]
- Correlation of immune responses to vaccination with myeloma responsiveness to lenalidomide [ Designated as safety issue: No ]
Estimated Enrollment: |
40 |
Study Start Date: |
January 2007 |
Estimated Primary Completion Date: |
June 2008 (Final data collection date for primary outcome measure) |
Group 1: Experimental
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).
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Drug: lenalidomide
Given orally
Drug: pneumococcal polyvalent vaccine
Given intramuscularly
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Group 2: Experimental
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).
|
Drug: lenalidomide
Given orally
Drug: pneumococcal polyvalent vaccine
Given intramuscularly
|
OBJECTIVES:
Primary
- Determine whether lenalidomide can augment the efficacy of pneumococcal polyvalent vaccine as it correlates with lenalidomide-induced antitumor efficacy in patients with relapsed or refractory multiple myeloma.
Secondary
- Determine the antibody responses to pneumococcal serotypes in patients treated with this regimen.
- Determine T-cell responses to the carrier protein CRM 197 in patients treated with this regimen.
- Determine the ability of lenalidomide to augment in vivo immune responsiveness as measured by cutaneous delayed-type hypersensitivity (DTH) reactions to Candida and tetanus in these patients.
- Determine the ability of lenalidomide to prime and/or boost systemic vaccine responses in both peripheral blood lymphocytes and marrow lymphocytes in these patients.
OUTLINE: Patients are assigned to 1 of 2 treatment groups.
- 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).
- 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).
After completion of study treatment, patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.