Clinical trial · Interventional
Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1))
Phase I Clinical Trial of Vorinostat (MK-0683) in Combination With Bortezomib in Patients With Advanced Multiple Myeloma
NCT00111813CI-TRIAL-00017992completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- vorinostat 200 mg + bortezomib 0.7 mg/m^2
- description
- Vorinostat capsules given twice daily (b.i.d.); bortezomib injection given on Days 4, 8, 11, and 15 of each cycle.
- interventionNames
- Drug: vorinostat
- Drug: bortezomib
- type
- EXPERIMENTAL
- label
- vorinostat 200 mg + bortezomib 0.9 mg/m^2
- description
- Vorinostat capsules given b.i.d.; bortezomib injection given on Days 4, 8, 11, and 15 of each cycle.
- interventionNames
- Drug: vorinostat
- Drug: bortezomib
- type
- EXPERIMENTAL
- label
- vorinostat 300 mg + bortezomib 1.3 mg/m^2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDWeber DM, Graef T, Hussein M, Sobecks RM, Schiller GJ, Lupinacci L, Hardwick JS, Jagannath S. Phase I trial of vorinostat combined with bortezomib for the treatment of relapsing and/or refractory multiple myeloma. Clin Lymphoma Myeloma Leuk. 2012 Oct;12(5):319-24. doi: 10.1016/j.clml.2012.07.007. PMID 23040438