Lenalidomide and Vaccine Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00445484
First received: March 7, 2007
Last updated: March 23, 2014
Last verified: March 2014

March 7, 2007
March 23, 2014
January 2007
April 2009   (final data collection date for primary outcome measure)
  • Humoral and cellular response [ Designated as safety issue: No ]
  • Efficacy of pneumococcal polyvalent vaccine [ Designated as safety issue: No ]
  • Humoral and cellular response, as determined by increase in IgG antibody titres to 6B, 16, 19F, and 23F
  • Efficacy of pneumococcal polyvalent vaccine
Complete list of historical versions of study NCT00445484 on ClinicalTrials.gov Archive Site
  • Changes in delayed-type hypersensitivity reactions to Candida and tetanus in the presence of lenalidomide [ Designated as safety issue: No ]
  • Immune responses to carrier protein CRM 197 in peripheral blood and bone marrow [ Designated as safety issue: No ]
  • Effect of lenalidomide on T-cell activation in blood and bone marrow [ Designated as safety issue: No ]
  • Correlation of immune responses to vaccination with myeloma responsiveness to lenalidomide [ Designated as safety issue: No ]
  • Changes in delayed-type hypersensitivity responses to Candida and tetanus in the presence of lenalidomide
  • Immune responses to carrier protein CRM 197 in peripheral blood and bone marrow
  • Effect of lenalidomide on T-cell activation in blood and bone marrow
  • Immune responses to vaccination with myeloma responsiveness to lenalidomide
Not Provided
Not Provided
 
Lenalidomide and Vaccine Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma
Revlimid to Augment Efficacy of Prevnar Vaccines in Patients With Relapsed or Refractory Myeloma

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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma and Plasma Cell Neoplasm
  • Biological: pneumococcal polyvalent vaccine
    Given intramuscularly
  • Drug: lenalidomide
    Given orally
  • Experimental: 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).
    Interventions:
    • Biological: pneumococcal polyvalent vaccine
    • Drug: lenalidomide
  • Experimental: 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).
    Interventions:
    • Biological: pneumococcal polyvalent vaccine
    • Drug: lenalidomide
Noonan K, Rudraraju L, Ferguson A, Emerling A, Pasetti MF, Huff CA, Borrello I. Lenalidomide-induced immunomodulation in multiple myeloma: impact on vaccines and antitumor responses. Clin Cancer Res. 2012 Mar 1;18(5):1426-34. doi: 10.1158/1078-0432.CCR-11-1221. Epub 2012 Jan 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2010
April 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00445484
J06102 CDR0000532944, P30CA006973, JHOC-J06102, JHOC-NA_00006008, CELGENE-CC-5013
Not Provided
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Ivan Borrello, MD Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP