Revlimid to Augment Efficacy of Prevnar Vaccines in Patients With Relapsed or Refractory Myeloma
18 Years
N/A
Both
Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
Revlimid to Augment Efficacy of Prevnar Vaccines in Patients With Relapsed or Refractory 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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Humoral and cellular response
Safety Issue:
No
Principal Investigator
Ivan Borrello, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Sidney Kimmel Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000532944
NCT ID:
NCT00445484
Start Date:
January 2007
Completion Date:
Related Keywords:
- Multiple Myeloma and Plasma Cell Neoplasm
- stage II multiple myeloma
- stage III multiple myeloma
- refractory multiple myeloma
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
Name | Location |
|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
