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

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.

DISEASE CHARACTERISTICS:

• Diagnosis of multiple myeloma (MM) meeting all of the following criteria:

• Relapsed or refractory disease
• Previously received ≥ 2 courses of antimyeloma treatment
• Measurable levels of myeloma paraprotein in serum (> 0.5 g/dL) or urine (> 0.2 g/24-hour urine collection) OR serum-free light-chain disease

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Absolute neutrophil count ≥ 1,000/mm^3
• Platelet count ≥ 75,000/mm^3
• Creatinine ≤ 2.5 mg/dL
• Bilirubin ≤ 2.0 mg/dL
• AST and ALT ≤ 3 times upper limit of normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use 2 methods of highly effective contraception ≥ 4 weeks before, during, and for 4 weeks after completion of study therapy
• No other malignancy within the past 5 years except treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
• No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude study treatment or put patient at unacceptable risk
• No known hypersensitivity to thalidomide or lenalidomide

• No development of erythema nodosum in the presence of a reaction characterized by a desquamating rash while taking thalidomide or similar drugs
• No known hypersensitivity to any component of the pneumococcal polyvalent vaccine, including diphtheria toxin or CRM 197
• No known HIV positivity
• No infectious hepatitis type A, B, or C

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No more than 3 prior treatment regimens for MM
• More than 6 months since prior lenalidomide
• More than 28 days since prior experimental drug or therapy
• More than 1 month since prior systemic antimyeloma therapy
• More than 1 month since prior and no concurrent systemic corticosteroids
• No other concurrent anticancer agents or treatments or investigational agents
• No concurrent thalidomide
• No concurrent radiotherapy
• No other concurrent immune therapy or immunomodulatory agents