Status:
COMPLETED
Lenalidomide and Vaccine Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Multiple Myeloma and Plasma Cell Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 respon...
Detailed Description
OBJECTIVES: Primary * Determine whether lenalidomide can augment the efficacy of pneumococcal polyvalent vaccine as it correlates with lenalidomide-induced antitumor efficacy in patients with relaps...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00445484
Start Date
January 1 2007
End Date
September 1 2010
Last Update
August 24 2015
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410