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Revlimid to Augment Efficacy of Prevnar Vaccines in Patients With Relapsed or Refractory Myeloma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma and Plasma Cell Neoplasm

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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 HopkinsBaltimore, Maryland  21231-2410