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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00642954 |
This is a Phase I study of vorinostat in combination with lenalidomide and dexamethasone in the patients with relapsed or refractory multiple myeloma.
Patients will receive up to 8 cycles treatment with 28-day in each cycle. The safety and tolerability of the combination regimen will be evaluated in this study.
Condition | Intervention | Phase |
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Relapsed or Refractory Multiple Myeloma |
Drug: vorinostat Drug: Comparator: lenalidomide Drug: Comparator: Dexamethasone |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Study of Vorinostat in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma |
Estimated Enrollment: | 44 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Dose escalation study. Level 1: 300 mg q.d. vorinostat p.o. for 14 days in combination with 10 mg q.d. lenalidomide p.o. for 21 days. Level 2: 400 mg q.d. vorinostat p.o. for 14 days in combination with 10 mg q.d. lenalidomide p.o. for 21 days. Level 3: 400 mg q.d. vorinostat p.o. for 14 days in combination with 15 mg q.d. lenalidomide p.o. for 21 days. Level 4: 400 mg q.d. vorinostat p.o. for 14 days in combination with 20 mg q.d. lenalidomide p.o. for 21 days. Level 5: 400 mg q.d. vorinostat p.o. for 14 days in combination with 25 mg q.d. lenalidomide p.o. for 21 days. 40 mg q.d. Dexamethasone p.o. will be given in each levels on days 1, 8 , 15 and 22 of each treatment cycle. Each treatment cycle will be 28 days with a maximum of 8 treatment cycles. |
Drug: vorinostat
Dose escalation study. Level 1: 300 mg q.d. vorinostat p.o. for 14 days. Level 2, 3, 4 & 5: 400 mg q.d. vorinostat p.o. for 14 days. Each treatment cycle will be 28 days with a maximum of 8 treatment cycles.
Drug: Comparator: lenalidomide
Dose escalation study. Level 1 & 2: 10 mg q.d. lenalidomide p.o. for 21 days. Level 3: 15 mg q.d. lenalidomide p.o. for 21 days. Level 4: 20 mg q.d. lenalidomide p.o. for 21 days. Level 5: 25 mg q.d. lenalidomide p.o. for 21 days.Each treatment cycle will be 28 days with a maximum of 8 treatment cycles.
Drug: Comparator: Dexamethasone
Dose escalation study. 40 mg q.d. Dexamethasone p.o. will be given in each levels on days 1, 8 , 15 and 22 of each treatment cycle. Each treatment cycle will be 28 days with a maximum of 8 treatment cycles.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Toll Free Number | 1-888-577-8839 |
United States, Massachusetts | |
Call for Information | Recruiting |
Boston, Massachusetts, United States, 02115 | |
United States, New Jersey | |
Call for Information | Recruiting |
Hackensack, New Jersey, United States, 07601 | |
United States, Texas | |
Call for Information | Recruiting |
Houston, Texas, United States, 77030-0000 | |
France | |
Laboratoires Merck Sharp & Dohme - Chibret | Recruiting |
Paris Cedex 8, France, 75114 | |
Contact: Jean-Marie Goehrs 33-1-4754-89-90 |
Study Director: | Medical Monitor | Merck |
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2007_511, MK0683-074 |
Study First Received: | March 17, 2008 |
Last Updated: | April 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00642954 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anticarcinogenic Agents Dexamethasone Anti-Inflammatory Agents Blood Protein Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Hemorrhagic Disorders Anti-Inflammatory Agents, Non-Steroidal Analgesics Dexamethasone acetate |
Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hematologic Diseases Blood Coagulation Disorders Vorinostat Vascular Diseases Lenalidomide Glucocorticoids Multiple Myeloma Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Anticarcinogenic Agents Anti-Inflammatory Agents Dexamethasone Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Hemorrhagic Disorders Sensory System Agents Therapeutic Uses |
Anti-Inflammatory Agents, Non-Steroidal Cardiovascular Diseases Analgesics Dexamethasone acetate Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Vorinostat Gastrointestinal Agents Vascular Diseases Lenalidomide Enzyme Inhibitors Protective Agents |