Clinical trial · Interventional
A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Patients With Relapse or Refractory Multiple Myeloma
A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-parallel Group, Phase 3 Study to Compare Efficacy and Safety of Masitinib 6 mg/kg/Day in Combination With Bortezomib and Dexamethasone to Placebo in Combination With Bortezomib and Dexamethasone in the Treatment of Patients With Relapsing Multiple Myeloma Who Received One Previous Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision based on portfolio prioritization
Summary
Brief summary (as posted)
The purpose of the study is to compare the efficacy and safety of masitinib 6 mg/kg/day in combination with bortezomib and dexamethasone to placebo in combination with bortezomib and dexamethasone in the treatment of patients with relapsing multiple myeloma who have received one previous therapy.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Masitinib | Drug | Masitinib | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Masitinib
- description
- Masitinib (6 mg/kg/day) in combination with Bortezomib and Dexamethasone
- interventionNames
- Drug: Masitinib
- Drug: Bortezomib
- Drug: Dexamethasone
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo in combination with Bortezomib and Dexamethasone
- interventionNames
- Drug: Placebo
- Drug: Bortezomib
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Progression Free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient with confirmed multiple myeloma requiring systemic therapy. A 2. Patient with multiple myeloma relapsing according to the International uniform response criteria for multiple myeloma (IMWG 2009/ revised Bladé criteria) to one previous line of treatment 3. Patient with measurable progressive disease Exclusion Criteria: 1. Patient with peripheral neuropathy Grade \>2 2. Patient with hypersensitivity to bortezomib, boron or dexamethasone 3. Patient whose disease progressed during or within 60 days of bortezomib treatment or of any other Multiple Myeloma therapy 4. Patient who received bortezomib within 6 months of randomization to this study 5. Past discontinuation of bortezomib due to associated grade 3 or higher adverse event 6. Patient with contra-indication to high dose of steroids (including ongoing active infection, use of live vaccines, virosis such as hepatitis, herpes, varicella, herpes zoster)
References
Publications (0)
Data not yet available