Clinical trial · Interventional
A Study Designed to Evaluate the Safety and Efficacy of Venetoclax Plus Dexamethasone (VenDex) Compared With Pomalidomide Plus Dexamethasone (PomDex) in Participants With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma.
A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Subjects With t(11;14)-Positive 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
Summary
Brief summary (as posted)
A study designed tocompare progression-free survival (PFS) in participants with t(11;14)-positive MM treated with venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone.
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 (2)
- type
- EXPERIMENTAL
- label
- Arm 1 VenDex
- description
- Venetoclax administered orally once daily (QD) plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.
- interventionNames
- Drug: Dexamethasone
- Drug: Venetoclax
- type
- ACTIVE_COMPARATOR
- label
- Arm 2 PomDex
- description
- Pomalidomide administered orally once daily (QD) on Days 1 - 21 for each 28-day cycle plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.
- interventionNames
- Drug: Pomalidomide
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Documented diagnosis of multiple myeloma (MM) based on standard International Myeloma Working Group (IMWG) criteria. * Measurable disease at screening as defined per protocol. * Has received at least 2 prior lines of therapy as described in the protocol. * Has had documented disease progression on or within 60 days after completion of the last therapy. * Has received at least 2 consecutive cycles of lenalidomide and be relapsed/refractory to lenalidomide, as defined per protocol. * Has received at least 2 consecutive cycles of a proteasome inhibitor (PI). * Has t(11;14)-positive status determined by an analytically validated fluorescent in situ hybridization (FISH) assay per centralized laboratory testing. * An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. * Laboratory values (liver, kidney and hematology laboratory values) that meet criteria as described per protocol. Exclusion Criteria: * History of treatment with venetoclax or another B-Cell Lymphoma (BCL)-2 inhibitor or pomalidomide. * History of other active malignancies, including myelodysplastic syndromes (MDS), within the past 3 years (exceptions described in the protocol). * Evidence of ongoing graft-versus-host disease (GvHD) if prior stem cell transplant (SCT). * Prior treatment with any of the following: allogeneic or syngeneic SCT within 16 weeks prior to randomization; or autologous SCT within 12 weeks prior to randomization. * Known central nervous system involvement of MM. * Concurrent conditions as listed in the protocol.
References
Publications (1)
- DERIVEDPopat R, Beksac M, Dimopoulos MA, Gatt ME, Gay F, Jo JC, Kapoor P, Katodritou E, Kortum KM, Ling S, Nagarajan C, Suzuki K, Qiu L, Onishi M, Ku G, Dail M, Mukherjee N, Ross JA, Badawi MA, Fusco MJ, Dobkowska E, Arriola E, Bueno OF, Bahlis NJ, Iida S, Moreau P, Valent J, Mateos MV. Venetoclax-Dexamethasone Versus Pomalidomide-Dexamethasone in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma: Primary Results of the Randomized, Phase III CANOVA Study. J Clin Oncol. 2026 Jan 20;44(3):164-175. doi: 10.1200/JCO-25-00924. Epub 2025 Dec 10. PMID 41370738