Clinical trial · Interventional
A Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma
A Phase 2, Open-Label, Multicenter, Dose-Escalation and Expansion Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Following results of the primary progression-free survival analysis from Study NCT02755597, company-sponsored MM studies were placed on partial clinical hold (PCH). Sponsor did not pursue release of the PCH for this study.
Summary
Brief summary (as posted)
This was an open-label, multicenter study designed to evaluate the safety and preliminary efficacy of venetoclax combined with pomalidomide and dexamethasone in participants with relapsed or refractory (R/R) multiple myeloma (MM) who received at least 1 prior line of therapy with documented evidence of progression during or after the participant's last treatment regimen. The study was designed to consist of 2 parts: Part 1 (dose escalation) and Part 2 (dose expansion). For Part 2 the participants were to be divided into 2 cohorts, participants positive for t(11;14) translocation and participants negative for t(11;14) translocation.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Pomalidomide | Drug | Pomalidomide | ALIAS |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Part 1: Dose Escalation
- description
- Venetoclax (400 mg oral \[PO\], once daily \[QD\]) administered with pomalidomide (4 mg PO, QD) and dexamethasone (40 mg once weekly \[qw\]) in 28-day cycles until documented disease progression, documented unacceptable toxicity, withdrawal of consent, or the participant met other criteria for discontinuation per study protocol
- interventionNames
- Drug: Venetoclax
- Drug: Pomalidomide
- Drug: Dexamethasone
- type
- EXPERIMENTAL
- label
- Part 2: Dose Expansion, t(11;14) positive
- description
- Participants positive for t(11;14) translocation were to receive the venetoclax dose determined to be safe in Part 1 as well as pomalidomide (4 mg oral \[PO\], once daily \[QD\]) and dexamethasone (40 mg once weekly \[qw\])
- interventionNames
- Drug: Venetoclax
- Drug: Pomalidomide
- Drug: Dexamethasone
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Relapsed or refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen * Measurable disease as described in the protocol * Received at least 1 prior line of therapy as described in the protocol * Must meet prior antimyeloma treatment parameters, as described in the protocol, and includes: * Received at least 2 consecutive cycles of lenalidomide or a lenalidomide-containing regimen * Refractory to lenalidomide * Exposed to a proteasome inhibitor (PI) alone or in combination with another agent * Had a response of partial response (PR) or better to prior therapy based on the investigator's determination of response as defined by International Myeloma Working Group (IMWG) criteria * Has t(11;14) status as described in the protocol and meets the following criteria: * For Part 1: MM participants independent of cytogenetic profile * For Part 2, Arm A: participant must be t(11;14) positive * For Part 2, Arm B: participant must be t(11;14) negative * An Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Adequate kidney, liver and hematologic laboratory values Exclusion Criteria: * Previous treatment with venetoclax or other BCL-2 inhibitors, or previous treatment with pomalidomide * Known sensitivity to any IMiDs * Allogenic or syngeneic stem cell transplant within 6 months before the first dose of study drug or active ongoing graft versus host disease * Autologous stem cell transplant within 12 weeks before the first dose of study drug * Known meningeal involvement of MM
References
Publications (1)
- DERIVEDGasparetto C, Bowles KM, Abdallah AO, Morris L, Mander G, Coppola S, Wang J, Ross JA, Bueno OF, Arriola E, Mateos MV. A Phase II Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2021 Nov;21(11):775-784. doi: 10.1016/j.clml.2021.07.029. Epub 2021 Aug 1. PMID 34551886