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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00602641 |
RATIONALE: Drugs used in chemotherapy, such as melphalan and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide and lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It is not yet known whether melphalan and prednisone are more effective when given together with thalidomide or lenalidomide in treating multiple myeloma.
PURPOSE: This randomized phase III trial is studying giving melphalan and prednisone together with thalidomide to see how well it works compared with giving melphalan and prednisone together with lenalidomide in treating patients with newly diagnosed multiple myeloma.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Drug: lenalidomide Drug: melphalan Drug: prednisone Drug: thalidomide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | An Intergroup Phase III Randomized Controlled Trial Comparing Melphalan, Prednisone and Thalidomide (MPT) Versus Melphalan, Prednisone and Lenalidomide (Revlimid™) (MPR) in Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for High-Dose Therapy |
Estimated Enrollment: | 560 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients receive oral melphalan and oral prednisone once daily on days 1-4, and oral thalidomide once daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients then receive oral thalidomide once daily and continue in the absence of disease progression.
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Drug: melphalan
Oral
Drug: prednisone
Oral
Drug: thalidomide
Oral
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Arm II: Experimental
Patients receive oral melphalan and oral prednisone once daily on days 1-4, and oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients then receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression.
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Drug: lenalidomide
Oral
Drug: melphalan
Oral
Drug: prednisone
Oral
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OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a multicenter study. Patients are stratified according to ISS stage (I-II vs III) and age (< 65 vs ≥ 65). Patients are randomized to 1 of 2 treatment arms.
Arm I:
Arm II:
Quality of life is assessed at baseline and periodically during treatment.
Peripheral blood and bone marrow samples are collected at baseline for gene expression profiling analysis.
After completion of study treatment, patients will be followed periodically for 10 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Newly diagnosed multiple myeloma (MM), meeting the following criteria:
Symptomatic disease with evidence of end-organ damage at initial diagnosis that prompted the initiation of therapy, including ≥ 1 of the following:
No smoldering MM, defined by all of the following:
No monoclonal gammopathy of undetermined significance, defined by all of the following:
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness that would limit compliance with the study including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
No prior treatment for myeloma except for either of the following:
Study Chair: | A. Keith Stewart, MD | Mayo Clinic Scottsdale |
Investigator: | S. V. Rajkumar, MD | Mayo Clinic |
Study ID Numbers: | CDR0000583984, ECOG-E1A06 |
Study First Received: | January 18, 2008 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00602641 |
Health Authority: | Unspecified |
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Melphalan Prednisone Immunoproliferative Disorders Thalidomide Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Lenalidomide |
Vascular Diseases Paraproteinemias Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Anti-Infective Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Anti-Bacterial Agents Therapeutic Uses Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents |
Alkylating Agents Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents, Hormonal Growth Substances Immunosuppressive Agents Glucocorticoids Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Leprostatic Agents |