A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Patients With Relapse or Refractory Multiple Myeloma

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01470131
• Date of registration: 25/10/2011
• Prospective Registration: No
• Primary sponsor: AB Science
• Public title: A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Patients With Relapse or Refractory Multiple Myeloma
• Scientific title: 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
• Date of first enrolment: May 2011
• Target sample size: 147
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01470131
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

France, United States

Contacts

• Name: Bertrand Arnulf, MD
• Affiliation: Hôpital Saint-Louis, Paris - France

Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Myeloma

Intervention(s)

Drug: Dexamethasone

Drug: Placebo

Drug: Bortezomib

Drug: Masitinib

Primary Outcome(s)

Progression Free Survival [Time Frame: Analysis to be conducted after a minimum of 201 events]

Secondary Outcome(s)

Overall Survival [Time Frame: Until death]

Overall Time to Progression [Time Frame: time from the date of randomization to the date of documented progression during the study]

Secondary ID(s)

AB06002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors