Phase 1
Completed N=34
Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1))
Source: ClinicalTrials.gov NCT00111813 ↗Enrolled (actual)
34
Serious AEs
38.2%
Results posted
Apr 2011
Primary outcomePrimary: Mean Duration of Treatment With Vorinostat — 4.6; 72.6; 107.1 Days
Summary
The purposes of this study are:
* To determine the maximum tolerated dose (MTD) for the combination of oral vorinostat and bortezomib in participants with advanced multiple myeloma
* To assess the safety and tolerability of this regimen and to document the participant's clinical status (by anti-tumor activity) for this combination, as determined per standard of care.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Duration of Treatment With Vorinostat |
4.6; 72.6; 107.1 | — |
| SECONDARY Number of Participants With Dose Modifications of Either Vorinostat or Bortezomib Due to Adverse Experiences (AEs) After Treatment With Study Drug |
3; 3; 8; 4; 3; 3 | — |
| SECONDARY Mean Time to First AE Resulting in a Dose Modification in Either Vorinostat or Bortezomib |
NA; NA; 58; 58; 128; 32 | — |
| SECONDARY Clinical AE Summary |
3; 3; 10; 6; 6; 6 | — |
| SECONDARY Laboratory AE Summary |
1; 1; 3; 0; 2; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Adults with refractory or relapsed multiple myeloma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (a measurement to determine participant's ability to perform daily activities)
- Adequate bone marrow reserve
- Adequate hepatic and renal function
- Ability to swallow capsules
- 3 weeks or more since prior chemotherapy and have recovered from prior toxicities
Exclusion Criteria
- Participants who plan to have a bone marrow transplant within 4 weeks of start of treatment
- Participants with prior treatment with other investigational agents with a similar anti-tumor mechanism
- Participants with other active/uncontrolled clinically significant illness
- Pregnant or nursing female participants
- Participants who received bortezomib within 3 months of start of this trial
Data sourced from ClinicalTrials.gov (NCT00111813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.