Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma

• Status: Active, not recruiting
• Trial end date: 2024-05-02
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the safety and efficacy of three different regimens of PAN (20 mg TIW, 20 mg BIW, and 10 mg TIW) in combination with s.c. BTZ and Dex and to provide exposure, safety and efficacy data to identify the optimal regimen of PAN in a randomized, 3-arm parallel design. This study will also assess the impact of administering s.c. BTZ (in combination with PAN and Dex) twice weekly for 4 cycles, and then weekly starting from Cycle 5 until disease progression in patients ≤ 75 years of age. Patients > 75 years of age will receive for the entire treatment period s.c. BTZ weekly (in combination with PAN and Dex) until disease progression.

Patients will be treated until disease progression or until they discontinue earlier due to unacceptable toxicity or for other reasons.

Patients who discontinued study treatment for reasons other than disease progression will be followed for efficacy every 6 weeks.

All patients will be followed for survival until the last patient entering long-term follow-up has completed a 3 year survival follow-up or discontinued earlier.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals; SecuraBio
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Panobinostat

Criteria

Inclusion Criteria:

• multiple myeloma as per IMWG 2014 definition

• requiring treatment for relapsed or relapsed/refractory disease

• measurable disease based on central protein assessment

• 1 to 4 prior lines of therapy

• prior IMiD exposure

• acceptable lab values prior to randomization

Exclusion Criteria:

• primary refractory myeloma

• refractory to bortezomib

• concomitant anti-cancer therapy (other then BTZ/Dex and bisphosphonates)

• prior treatment with DAC inhibitors

• clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months prior to randomization)

• unresolved diarrhea ≥ CTCAE grade 2 or presence of medical condition associated with chronic diarrhea (such as irritable bowel syndrome, inflammatory bowel disease)

Other protocol-defined inclusion/exclusion criteria may apply.