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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00445484 |
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.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Drug: lenalidomide Drug: pneumococcal polyvalent vaccine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Revlimid to Augment Efficacy of Prevnar Vaccines in Patients With Relapsed or Refractory Myeloma |
Estimated Enrollment: | 40 |
Study Start Date: | January 2007 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1: Experimental
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).
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Drug: lenalidomide
Given orally
Drug: pneumococcal polyvalent vaccine
Given intramuscularly
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Group 2: Experimental
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).
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Drug: lenalidomide
Given orally
Drug: pneumococcal polyvalent vaccine
Given intramuscularly
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OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are assigned to 1 of 2 treatment groups.
After completion of study treatment, patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma (MM) meeting all of the following criteria:
PATIENT CHARACTERISTICS:
No known hypersensitivity to thalidomide or lenalidomide
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
Baltimore, Maryland, United States, 21231-2410 | |
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu |
Study Chair: | Ivan Borrello, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000532944, JHOC-J06102, JHOC-NA_00006008, CELGENE-CC-5013 |
Study First Received: | March 7, 2007 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00445484 |
Health Authority: | Unspecified |
stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Lenalidomide Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Neoplasms Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Cardiovascular Diseases Pharmacologic Actions |