Multiple Myeloma
Conditions
Brief summary
The purposes of this study are: * To determine the maximum tolerated dose (MTD) of SAHA administered every 12 hours for 14 consecutive days followed by 7 days of rest during the first two cycles (i.e., first 6 weeks) in patients with advanced multiple myeloma; * To assess the safety and overall response rate to SAHA in patients with advanced multiple myeloma.
Interventions
DRUGMK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment - Up to 8 Cycles or 6 months
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients with refractory or relapsed multiple myeloma, ECOG performance status 0-2 (ECOG) * Adequate bone marrow reserve * Adequate hepatic and renal function * Ability to swallow capsules * 3 weeks or more from prior chemotherapy and have recovered from prior toxicities
Exclusion criteria
* Patients who plan to go for bone marrow transplant within 4 weeks of start of treatment * Patients with prior treatment with other investigational agents with a similar anti-tumor mechanism * Patients with other active/uncontrolled clinically significant illnesses * Pregnant or nursing female patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PHASE I: Maximum tolerated dose (MTD) of vorinostat in patients with advanced multiple myeloma. | — |
| PHASE II: Safety and overall response rate to SAHA in patients with advanced multiple myeloma. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Anti-tumor activity in patients with advanced multiple myeloma; 2) Biological effects of SAHA in peripheral mononuclear cells and bone marrow plasma cells; 3) Correlation of biological effects of SAHA with serum drug concentration. | — |
Outcome results
None listed