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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00807599 |
The purpose of this study is to compare the effects, good and bad, of two ways to treat patients with standard-risk symptomatic multiple myeloma. Patients with standard-risk myeloma have myeloma with specific features: levels of 2 blood tests have to be in a specific range and there can be no myeloma tumors found outside of the bones or bone marrow, the areas where myeloma is usually discovered. In past clinical studies, patients with standard-risk myeloma have done well with intensive therapy in the form of stem cell transplant. But multiple myeloma is not curable and, although it may respond to standard treatments including stem cell transplant, myeloma always recurs.
Condition | Intervention | Phase |
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Multiple Myeloma |
Procedure: Stem cell transplant x 1 or x 2 Drug: lenalidomide and dexamethasone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | A Phase II Clinical Trial for Untreated Patients With Multiple Myeloma Eligible for Stem Cell Transplant: Lenalidomide (Revlimid) Plus Low-Dose Dexamethasone (Ld x 4 Cycles) Then Stem Cell Collection Followed by Randomization to Continued Ld or Stem Cell Transplantation (SCT) Plus Maintenance Ld for SCT Patients Not Achieving at Least Very Good Partial Response (VGPR) or Having High-Risk Disease |
Estimated Enrollment: | 88 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Stem cell transplant x 1 or x 2: Experimental
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :
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Procedure: Stem cell transplant x 1 or x 2
After 4 cycles of Ld, eligible patients will be referred to the main campus for stem cell mobilization and collection with standard-of-care cyclophosphamide (3000mg/m2 as an inpatient for 1-2 days) and Neupogen (G-CSF). Ld will be held for at least 2 weeks prior to stem cell mobilization. Patients will then be randomized to continued Ld or high-dose melphalan with SCT. Patients not achieving VGPR by 4 months after the 1st SCT will undergo a 2nd SCT. Patients not achieving VGPR after tandem transplant and patients in the high-risk group will receive maintenance Ld (L=10mg/day and d=20mg flat dose weekly).
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Continue lenalidomide and dexamethasone: Experimental
All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either : stem cell transplant right after collection
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Drug: lenalidomide and dexamethasone
Patients will then be randomized to continued Ld or high-dose melphalan with SCT. Patients not achieving VGPR by 4 months after the 1st SCT will undergo a 2nd SCT.Patients not achieving VGPR after tandem transplant and patients in the high-risk group will receive maintenance Ld (L=10mg/day and d=20mg flat dose weekly). Patients will continue on the Ld and SCT arms of therapy until progression of disease.
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New Jersey | |
Memoral Sloan Kettering Cancer Center | |
Basking Ridge, New Jersey, United States | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10065 | |
Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital | |
Sleepy Hollow, New York, United States | |
Memorial Sloan-Kettering at Mercy Medical Center | |
Rockville Centre, New York, United States | |
Memorial Sloan-Kettering Cancer Center @ Suffolk | |
Commack, New York, United States, 11725 |
Principal Investigator: | Raymond Comenzo, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Raymond Comenzo, MD ) |
Study ID Numbers: | 08-121 |
Study First Received: | December 11, 2008 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00807599 |
Health Authority: | United States: Institutional Review Board |
CYCLOPHOSPHAMIDE (CYTOXAN) DEXAMETHASONE G-CSF |
Lenalidomide MELPHALAN PEG-FILGRASTIM (NEULASTA) |
Dexamethasone Melphalan Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Lenalidomide Vascular Diseases Paraproteinemias |
Cyclophosphamide Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics |
Hormones Glucocorticoids Pharmacologic Actions Neoplasms Autonomic Agents Therapeutic Uses Cardiovascular Diseases Peripheral Nervous System Agents Central Nervous System Agents |