?An International, Multicenter, Open-Label Study of Vorinostat (MK-0683) in Combination with Bortezomib in Patients with Relapsed and Refractory Multiple Myeloma? Protocol 095-00 - ND
- Conditions
- Multiple MyelomaMedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
- Registration Number
- EUCTR2008-003753-33-IT
- Lead Sponsor
- MERCK & CO., INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 142
SUBJECT/PATIENT 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 myeloma
diagnostic criteria located in Appendix 6.5 [10; 11].
4. Patient has relapsed and refractory multiple myeloma after at least 2 prior treatment
regimens as per the EBMT response criteria located in Appendix 6.6 [12] 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).
5. Patient must have performance status of ≤ 2 on the ECOG Performance Scale located
in Appendix 6.7 [13].
6. Patient has measurable disease, defined as any quantifiable serum M-protein value
and, where applicable, urine light chain of ≥200 mg/24 hours.
7. Female patient of childbearing potential must have a negative serum pregnancy test
within 7 days prior to first dose of study drug.
8. Female patient of childbearing potential is willing to use 2 adequate barrier methods
of contraception to prevent pregnancy or agrees to abstain from heterosexual activity
throughout the study, starting with Visit 1 through 30 days after the last dose of study
drug. Adequate contraceptive methods include for example, intra-uterine device,
diaphragm with spermicide, cervical cap with spermicide, or female condom with
spermicide. Spermicides alone are not an acceptable method of contraception.
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
SUBJECT/PATIENT 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 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method