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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00619684 |
RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing.
PURPOSE: This phase II trial is studying how well lenalidomide works in treating patients with progressive or recurrent multiple myeloma after a donor stem cell transplant.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Drug: lenalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Lenalidomide Following Allogeneic Stem Cell Transplant for Multiple Myeloma Patients Who Relapse or Have Disease Progression |
Estimated Enrollment: | 18 |
Study Start Date: | December 2007 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 30 days and then every 3 months thereafter.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma
Disease progression or relapsed disease after prior allogeneic stem cell transplantation from a matched or mismatched related or unrelated donor
PATIENT CHARACTERISTICS:
Must be able to take aspirin (81 or 325 mg daily) as prophylactic anticoagulation
PRIOR CONCURRENT THERAPY:
No concurrent investigational GVHD drugs
United States, Washington | |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Recruiting |
Seattle, Washington, United States, 98109-1024 | |
Contact: Clinical Trials Office - Fred Hutchinson Cancer Research Cente 800-804-8824 | |
Seattle Cancer Care Alliance | Recruiting |
Seattle, Washington, United States, 98109-1023 | |
Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824 |
Principal Investigator: | William I. Bensinger, MD | Fred Hutchinson Cancer Research Center |
Responsible Party: | Fred Hutchinson Cancer Research Center ( William I. Bensinger ) |
Study ID Numbers: | CDR0000587513, FHCRC-2161.00, FHCRC-IR-6638 |
Study First Received: | February 20, 2008 |
Last Updated: | February 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00619684 History of Changes |
Health Authority: | Unspecified |
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Lenalidomide Disease Progression Vascular Diseases |
Paraproteinemias Hemostatic Disorders Recurrence Multiple Myeloma Hemorrhagic Disorders Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents Blood Protein Disorders Hematologic Diseases Lenalidomide Vascular Diseases Paraproteinemias |
Hemostatic Disorders Pharmacologic Actions Multiple Myeloma Neoplasms Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |