NCT02659293

Trial of Carfilzomib, Lenalidomide, Dexamethasone Versus Lenalidomide Alone After Stem-cell Transplant for Multiple Myeloma

Phase 3 Randomized Trial of Carfilzomib, Lenalidomide, Dexamethasone Versus Lenalidomide Alone After Stem-cell Transplant for Multiple Myeloma

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3 randomized trial of carfilzomib, lenalidomide, dexamethasone versus lenalidomide alone after stem-cell transplant for multiple myeloma, eligible to subjects who completed autologous stem cell transplant for symptomatic myeloma who are considered for lenalidomide maintenance.

Detailed description

Primary Objective: * To compare progression free survival between Kyprolis (Carfilzomib), Revlimid (lenalidomide), Dexamethasone (KRd) arm and lenalidomide arm Secondary Objectives * To determine the rate of minimal residual negative disease (MRD) at 6 and 12 months after randomization * To compare the efficacy (rate of partial response, very good partial response, complete response, and stringent complete response) of KRd vs. Lenalidomide alone after randomization

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Lenalidomide	* Cycle 1: 15 mg days 1-21 * Cycles 2-4: 25 mg days 1-21 if tolerated, otherwise continue at lower dose * Cycles 5 and beyond: best tolerated dose days 1-21
DRUG	Carfilzomib	* Cycle 1: 20 mg/m2 Days 1, 2; 36 mg/m2 Days 8, 9, 15, 16. Alternatively, intermediate dose escalation (to 27mg/m2 on days 8,9 of cycle 1) will be al12,lowed at the treating physician's discretion. * Cycle 2-4: 36 mg/m2 if tolerated Days 1, 2, 8, 9, 15, 16 * Cycles 5-8 (patients that are MRD- and have no risk factors at the end of cycle 6) and Cycle 5 - 36 (for MRD+ patients and high risk patients at the end of cycle 6): best tolerated dose Days 1, 2, 15, 16
DRUG	Dexamethasone	* Cycles 1 - 4: 20 mg PO or IV per dose Days 1, 8, 15, 22 * Cycles 5+: 20 mg or best tolerated dose PO or IV per dose Days 1, 8, 15, 22
DRUG	Lenalidomide (Control)	* Cycles 1-4: Days 1-28. Lenalidomide will begin at a dose of 10 mg PO daily (2 capsules per day). After three months, the dose will be increased, provided ANC ≥ 1,000/µL, platelet count ≥ 75,000/µL, and all nonhematologic toxicity is ≤ grade 1, to 15 mg PO daily (3 capsules per day). * Cycles 5 and beyond: best tolerated dose days 1-28

Timeline

• Start date: 2016-04-26
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2016-01-20
• Last updated: 2026-03-04

Locations

3 sites across 2 countries: United States, Poland