Cyclophosphamide With Biochemical Progression During Lenalidomide-Dexamethasone Treatment for Relapsed/Refractory Multiple Myeloma (MM)

PHASE2CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

April 30, 2015

Study Completion Date

July 31, 2018

Conditions
Multiple Myeloma
Interventions
DRUG

Cyclophosphamide

This protocol is a phase II multicenter, open label study designed to determine whether the addition of Cyclophosphamide to Rd (CRd) treatment significantly increases response rates and prolonged the outcome (PFS, OS) in patients who experienced a biochemical relapse, without CRAB under Rd treatment. The treatment period includes: administration of the combination CRd for 9 cycles. In order to assess the efficacy and safety of treatment, patients will attend the study center visits at least every 2 weeks. The response will be assessed after each cycle. During the LTFU period, after development of confirmed PD, all patients are to be followed for survival every 1-3 months via telephone or office visit.

DRUG

Lenalidomide

DRUG

Dexamethasone

Trial Locations (1)

00161

Policlinico Umberto I, Rome

All Listed Sponsors
lead

Fondazione EMN Italy Onlus

OTHER

NCT02206503 - Cyclophosphamide With Biochemical Progression During Lenalidomide-Dexamethasone Treatment for Relapsed/Refractory Multiple Myeloma (MM) | Biotech Hunter | Biotech Hunter