Lenalidomide and Vaccine Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Intervention: pneumococcal polyvalent vaccine; lenalidomide
Intervention description: Given intramuscularly; Given orally
Intervention MeSH terms: Lenalidomide; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage II multiple myeloma; stage III multiple myeloma; refractory multiple myeloma

Summary:

      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.
    

Eligibility criteria:

        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