Revlimid to Augment Efficacy of Prevnar Vaccines in Patients With Relapsed or Refractory Myeloma
- 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.
- Determine the antibody responses to pneumococcal serotypes in patients treated with
- Determine T-cell responses to the carrier protein CRM 197 in patients treated with this
- 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.
Masking: Open Label, Primary Purpose: Treatment
Humoral and cellular response
Ivan Borrello, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|