NCT02802163

Induction Therapy for Multiple Myeloma With Carfilzomib, Lenalidomide,Dexamethasone,Panobinostat

Phase I-II Study of Carfilzomib, Lenalidomide, Dexamethasone, and Panobinostat, Ca-R-Pa-Diem, as Induction Therapy for Newly Diagnosed, Untreated, Transplant-Eligible, Multiple Myeloma Patients

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study for Phase l is to determine the maximum tolerated dose of panobinostat given in combination with carfilzomib, lenalidomide, and dexamethasone in 28-day cycles as induction (initial) therapy to participants with newly diagnosed multiple myeloma. In Phase ll, investigators will evaluate the safety (side effects) and efficacy (effectiveness) of panobinostat in combination with carfilzomib, lenalidomide, and dexamethasone.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Panobinostat	Induction Phase: Panobinostat (dose escalation beginning at 10 mg) will be administered 3 times a week (TIW) by mouth every other week starting on day 1 of each cycle. Maintenance Phase: Panobinostat will be administered TIW by mouth every other week starting on day 1 of each cycle. The dose of panobinostat during maintenance phase will be the same dose taken during cyce 8 of induction phase.
DRUG	Carfilzomib	Induction Phase: Carfilzomib will be administered at 20 mg/m\^2 on Cycle 1 Day 1. Beginning on Cycle 1 Day 2 the carfilzomib dose will be according to the assigned level of 27 mg/m\^2 or 36 mg/m\^2. Carfilzomib will be administered twice weekly IV on Days 1,2, 8,9,15, and 16.
DRUG	Lenalidomide	Induction Phase: Lenalidomide (25 mg) will be administered once-daily by mouth on Days 1-21, 25. Maintenance Phase: Lenalidomide (10 mg) will be administered once-daily by mouth on days 1-21.
DRUG	Dexamethasone	Induction Phase: Dexamethasone (20 mg) will be administered twice weekly by mouth or by IV on Days 1,2, 8, 9, 15, and 16.

Timeline

• Start date: 2017-06-01
• Primary completion: 2020-09-01
• Completion: 2020-12-01
• First posted: 2016-06-16
• Last updated: 2017-04-25

Regulatory

• FDA-regulated drug study