An International, Multicenter, Open-Label Study of Vorinostat (MK-0683) in Combination with Bortezomib in Patients with Relapsed and Refractory Multiple Myeloma

• Conditions: multiple myeloma; MedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myeloma

• Registration Number: EUCTR2008-003753-33-GR
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-12
• Last Update Posted: 14 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

1. Patient has an established diagnosis of multiple myeloma based on myeloma diagnostic criteria.
2. Patient has relapsed or refractory multiple myeloma after at least 2 prior treatment regimens as per the EBMT response criteria and meets both of the following conditions:
• Patient's myeloma was refractory to bortezomib; defined as no response on prior bortezomib-containing regimens or progression on or within 60 days of a bortezomib-containing regimen.
• Patient was exposed to an IMiD (thalidomide or lenalidomide); defined as patients who received at least 1 dose of an IMiD and were intolerant to or whose myeloma relapsed or was refractory to IMiD containing regimen.
3. Patient has received at least 2 prior (standard or experimental) anti-myeloma regimens.

A full list of criteria can be found in the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patient has had any prior allogeneic bone marrow transplant (patient with prior autologous transplant is eligible).
2. Patient plans to undergo any type of bone marrow transplantation (allogeneic, or autologous) within 4 weeks after initiating study therapy.
3. Patient had prior treatment with vorinostat or other HDAC inhibitors (e.g., depsipeptide, MS-275, LAQ-824, PXD-101, LBH589, MGCD0103, CRA024781, etc.). Patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid, as anti-tumor therapy should not be enrolled in this study. Patients who have received such compounds for other indications, e.g. valproic acid for epilepsy, may enroll after a 30-day washout period.
4. Patient was unable to tolerate prior treatment with bortezomib.

A full list of criteria can be found in the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified