An International, Multicenter, Randomized, Double-Blind, Study of Vorinostat (MK-0683) or Placebo in Combination with Bortezomib in Patients Multiple MyelomaMK-0683-088 - ND

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

• Registration Number: EUCTR2008-003752-30-IT
• Lead Sponsor: MERCK & CO., INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-27
• Last Update Posted: 18 January 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

A patient must satisfy each of the following criteria in order to qualify for participation in
the study:
1. Patient, or the patient?s legal representative, has voluntarily agreed to participate by
giving written informed consent. For those institutions that do not allow a legal
representative to provide consent on behalf of a patient, patients must be able to
provide written informed consent for themselves.
2. Patient is ≥18 years of age on the day of signing informed consent.
3. Patient has an established diagnosis of multiple myeloma based on the myeloma
diagnostic criteria located in Appendix 6.2. [9; 10]
4. 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 located in Appendix 6.6
[11].
5. Patient who received prior bortezomib-containing regimen and meets the following
criteria is also eligible:
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. Bortezomib refractory is
defined as no response on prior bortezomib-containing regimens or
progression on or within 60 days of a bortezomib-containing regimen.
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

A patient meeting any of the following criteria is not eligible to participate in the study:
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 was unable to tolerate prior treatment with bortezomib.
5. Patient has uncontrolled intercurrent illness or circumstances that could limit
compliance with the study, including, but not limited to the following: acute or
chronic graft versus host disease, uncontrolled hypertension, symptomatic congestive
heart failure, unstable angina pectoris, myocardial infarction within past 6 months,
uncontrolled cardiac arrhythmia, renal failure, psychiatric or social conditions that
may interfere with patient compliance, or any other condition (including laboratory
abnormalities) that in the opinion of the Investigator places the patient at
unacceptable risk for adverse outcome if he/she were to participate in the study.

Study & Design

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