A Study of Vorinostat or Placebo in Combination with Bortezomib in Patients with Multiple Myeloma

• Conditions: Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]; multiple myeloma; MedDRA version: 13.1Level: PTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2008-003752-30-HU
• Lead Sponsor: Merck & Co., Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-08
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 742

Inclusion Criteria

1. Patient has an established diagnosis of multiple myeloma based on the myeloma diagnostic criteria.
2. Patient has received at least 1 but not more than 3 prior anti-myeloma regimens and has progressive disease after the most recent treatment regimen as per the European Blood and Marrow Transplantation Group
(EBMT) Criteria.
3. For any patient who received prior bortezomib-containing regimen the
patient must also meet the following criteria:

While on prior bortezomib-based therapy, the patient must have achieved a minimal response (MR), partial response (PR), or complete
response (CR).

Patient was not considered bortezomib refractory.

4. Patient has measurable disease, defined as any quantifiable serum Mprotein
value and/or, where applicable, urine M-protein of =200 mg/24 hours.
5. Patient has adequate organ function.

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 255
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 367

Exclusion Criteria

1. Patient has had any prior allogeneic bone marrow transplant (patient 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 has had prior treatment with vorinostat or 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 is receiving corticosteroid therapy (>10 mg of prednisone or
equivalent). However, use of =10 mg of prednisone or equivalent is allowed for reasons other than myeloma.

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