Clinical trial · Interventional
Multiple Ascending Dose (MAD) Combination in Subjects With Multiple Myeloma
A Phase Ib Multiple Ascending Dose Study of BMS-833923 Alone or in Combination With Lenalidomide (Revlimid) Plus Dexamethasone or in Combination With Bortezomib (Velcade) in Subjects With Relapsed or Refractory Multiple Myeloma
NCT00884546CI-TRIAL-00024104completedPhase 1ClinicalTrials.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)
To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-833923 administered alone, in combination with lenalidomide plus dexamethasone, or in combination with bortezomib in subjects with relapsed or refractory multiple myeloma.
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 |
|---|---|---|---|
| Advanced Cancer, Various, NOS | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-833923 | Drug | — | UNRESOLVED |
| Bortezomib | Drug | Bortezomib | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- BMS-833923 (Starting dose is a loading dose of 60 mg for 7 days with a 30 mg daily dose thereafter)
- interventionNames
- Drug: BMS-833923
- type
- ACTIVE_COMPARATOR
- label
- Arm 2
- description
- BMS-833923 (MTD or below) Lenalidomide (at or below the recommended prescribing dose) Dexamethasone (40 mg)
- interventionNames
- Drug: BMS-833923
- Drug: Lenalidomide
- Drug: Dexamethasone
- type
- ACTIVE_COMPARATOR
- label
- Arm 3
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of Multiple Myeloma * Men and Women at least 18 years old * ECOG status 0-2 * Last therapeutic or diagnostic treatment at least 21 days prior * Bone marrow transplants must have been completed at least 3 months prior * Any toxicity from prior therapies must have resolved to Grade ≤1 Exclusion Criteria: * Women pregnant or breastfeeding * WOCBP unwilling/unable to use acceptable method to avoid pregnancy * Uncontrolled medical disorder or active infection * Current or recent (w/in 3 months) gastrointestinal disorder * Inability to swallow oral medication * Inability to be venipunctured * Uncontrolled or significant cardiovascular disease * Uncontrolled hyperlipidemia * Intolerance of lenalidomide or bortezomib if participating in Arms B and C * Concurrent therapy with any other investigational product * Subjects involuntary incarcerated * Subjects detained for treatment of psychiatric or physical illness
References
Publications (0)
Data not yet available
No reference posted for this study.