A Study of Vorinostat in Combination with Bortezomib in Patients with Relapsed and Refractory Multiple Myeloma

Phase 1

• Conditions: multiple myeloma; MedDRA version: 14.0 Level: PT Classification code 10028228 Term: Multiple myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-27
• Study Completion: 2012-04-09
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 142

Inclusion Criteria

1. Patient has an established diagnosis of multiple myeloma based on myeloma diagnostic criteria.
2. Patient has relapsed and refractory multiple myeloma after at least 2 prior treatment regimens as per the EBMT response criteria and meets both of the following conditions:
• Refractory to Bortezomib (administered either alone or in combination with other agents); defined as no response on prior bortezomib containing regimens or progression on or within 60 days of a bortezomib-containing regimen.
• Relapsed, refractory, intolerant, and/or ineligible (in the opinion of the (Investigator) to other therapies, including an IMiD (thalidomide OR lenalidomide).
3. Patient has measurable disease, defined as any quantifiable serum Mprotein
value and/or, where applicable, urine M-protein of =200 mg/24 hours
4. Patient has received at least 2 prior (standard or experimental) antimyeloma
regimens.

A full list of inclusion criteria can be found in the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 82

Exclusion Criteria

1. Patient has had any prior allogeneic bone marrow transplant (patients with prior autologous transplant are 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 exclusion criteria can be found in the protocol.

Study & Design

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