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| Sponsor: | Merck |
|---|---|
| Information provided by (Responsible Party): | Merck |
| ClinicalTrials.gov Identifier: | NCT00642954 |
Purpose
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 |
|---|---|---|
|
Relapsed or Refractory Multiple Myeloma |
Drug: Comparator: vorinostat Drug: Comparator: lenalidomide Drug: Comparator: Dexamethasone |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Phase I
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 level 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: Comparator: 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 level 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT00642954 History of Changes |
| Other Study ID Numbers: | MK-0683-074, 2007_511 |
| Study First Received: | March 17, 2008 |
| Last Updated: | January 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Dexamethasone acetate |
Dexamethasone Dexamethasone 21-phosphate Vorinostat Lenalidomide Thalidomide BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents |