None listed
Conditions
Interventions
Group 1 Type of group
Four 100 mg capsules vorinostat taken orally, once daily, on Days 1-14 of each 21-day treatment cycle.
1.3 mg/m2 of bortezomib by IV push, on Days 1, 4, 8, and 11 of each 21-day treatment cycle.
Group name:gROUP 2 Type of group
1.3 mg/m2 of bortezomib by IV push, on Days 1, 4, 8, and 11 of each 21-day treatment cycle.
Four placebo capsules taken orally, once daily, on Days 1-14
Sponsors
MERCK & CO.INC.,
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: • The patient or the patient´s legal representative has voluntarily agreed to participate by giving written informed consent. In those institutions that do not allow a legal representative to grant consent on behalf of the patient, patients must be able to grant written informed consent for themselves. • The patient is> 18 years of age on the day he signs the informed consent. • The patient has an established diagnosis of multiple myeloma based on myeloma diagnostic criteria, included in Appendix 6.2. [9; 10] • The patient has received at least 1 but no more than 3 previous anti-myeloma regimens and has progressive disease after the most recent treatment regimen according to the criteria of the European Blood and Medullary Transplant Group (EBMTT) described in Appendix 6.6 [11] . • The patient who has previously received a regimen containing bortezomib, and meets the following criteria is also eligible: While receiving the previous therapy based on bortezomib, the patient must have reached a minimum response (minimal response, MR), a partial response (partial response, PR) or a complete response (CR). The patient was not considered refractory to treatment with bortezomib. Being refractory to bortezomib is defined as the lack of response to previous regimes containing bortezomib, or progression while receiving a regimen containing bortezomib or within 60 days of receiving it. • The patient has a functional status 200 mg / 24 hours. • The patient with the possibility of becoming pregnant should have a negative serum pregnancy test within 7 days before receiving the first dose of study medication. • The patient with the possibility of becoming pregnant is willing to use 2 adequate barrier contraceptive methods to prevent pregnancy or agrees to refrain from heterosexual activity throughout the study, from the visit 1 to 30 days after the last dose of the medication of the study. Suitable contraceptive methods include, for example, the intrauterine device, the diaphragm with spermicide, the cervical cap with spermicide or the female condom with spermicide. Spermicides alone are not an acceptable method of contraception. • The patient has an adequate function of the organs • The patient must allow at least 3 weeks from previous chemotherapy, radiotherapy, biological therapy, immunotherapy, major surgery or any other experimental antitumor therapy before the first dose of the study medications. • The patient has successfully recovered from the toxicities and / or complications of the previous therapy. • The patient can swallow capsules and can take or tolerate oral medications continuously. • The patient will be available for the periodic collection of blood samples and the performance and development of the tests related to the study in the hospital throughout the study.
Exclusion criteria
Exclusion criteria: • The patient has previously received an allogeneic bone marrow transplant. (Patients who have previously received an autologous transplant will be eligible.) • The patient plans to undergo any type of bone marrow transplant (allogeneic or autologous) within 4 weeks after the start of the study therapy. • The patient has received prior treatment with vorinostat or HDAC inhibitors (eg, depsipeptide, MS-275, LAQ-824, PXD-101, LBH589, MGCD0103, CRA024781, etc.). Patients who have been treated with compounds with activity analogous to that of the HDAC inhibitor, such as valproic acid, as antitumor therapy should not be included in this study. (Patients who received such compounds for other indications, e.g., valproic acid for epilepsy, can be recruited after a 30-day wash period). • The patient could not tolerate the previous treatment with bortezomib. • The patient suffers from an uncontrolled intercurrent disease or circumstances that may limit study compliance, including, but limited to the following: graft disease against acute or chronic host, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris , myocardial infarction within the last 6 months, uncontrolled cardiac arrhythmia, renal failure, psychiatric or social states that may interfere with patient compliance, or any other condition (including laboratory abnormalities) that, according to the researcher, put to the patient at unacceptable risk of having an adverse outcome if he / she participated in the study. • The patient has an active systemic infection that needs treatment. • The patient has acute infiltrative diffuse lung disease or pericardial disease. • The patient has known hypersensitivity to any component of bortezomib (such as boron, mannitol) or vorinostat. • The patient receives corticosteroid therapy (> 10 mg of prediüsona or its equivalent see Appendix 6.8). However, the use of grade 2 according to the NCICTC scale.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Defined as the time elapsed from randomization to disease progression or death from any cause, whichever comes first. According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) Measure:Progression Free Survival (PFS) Timepoints:During the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Defined as the time elapsed from randomization to death from any cause Measure:Global survival Timepoints:During the study ; Outcome name:Defined as the time elapsed from randomization to disease progression or death due to of myeloma Measure:Time to progression Timepoints:During the study ; Outcome name:Defined as the proportion of patients in the population of analysis that have complete response (GR), complete response (PR) or minimum response (MR) during the course of the study as determined by the lAC. (See Appendix 6.6 for the EBT response criteria) A second test will be required to confirm the response as described in the EBMT criteria. Measure:Response rate Timepoints:During the study | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, France, Germany, Greece, Hungary, India, Israel, Italy, Korea South, Malasya, Mexico, New Zealand, Philippines, Poland, Portugal, Romania, Russian Federation, South Africa, Spain, Taiwan, Thailand, Ukraine, United Kindgdom, United States
Contacts
Public ContactAlfredo San Martin
COVANCE PERU SERVICES S.A.
Outcome results
None listed