NCT01701076

Bendamustine, Lenalidomide (Revlimid®) and Dexamethasone (BRd) as 2nd-line Therapy for Patients With Relapsed or Refractory Multiple Myeloma

An Open, Multicentric Phase II Trial to Evaluate the Efficacy and Safety of Bendamustine, Lenalidomide (Revlimid®) and Dexamethasone (BRd) as 2nd-line Therapy for Patients With Relapsed or Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Cantonal Hospital of St. Gallen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Almost all patients with multiple myeloma who survive initial treatment will eventually relapse and require further therapy. Background: Treatment with lenalidomide and dexamethasone has proven efficacy in two large randomized trials (MM-009 and MM-010) leading to a time to progression (TTP) of 17.1 months for patients with only one prior therapy and a TTP of 10.6 months for 2 and more prior therapies, respectively \[1-3\]. Continuous treatment with lenalidomide and dexamethasone until disease progression is therefore considered a standard therapy for second line treatment in multiple myeloma patients. However, only a relatively low rate of high quality response (CR, complete response and VGPR, very good partial response) is achieved. High quality responses are associated with with improved progression-free survival and overall survival \[4\]. Trial: The aim of this trial is to improve high quality response rates for patients with relapsed or refractory multiple myeloma in the 2nd line treatment. This aim shall be achieved by the addition a third anti-myeloma drug (bendamustine) to the established backbone of lenalidomide/ dexamethasone. Treatment regimen: * Induction Treatment Phase: Cycles 1-6 Bendamustine 75mg/m2/d day 1 and 2, lenalidomide 25mg/d 1-21, dexamethasone 40mg / 20mg (for patients \> 75years) d 1, 8, 15, 22. * Maintenance Treatment Phase: Cycles 7-18 lenalidomide 25mg/d 1-21, dexamethasone 40mg / 20mg (for patients \> 75 years) d 1, 8, 15, 22. Due to hematoxicity of bendamustine and lenalidomide, administration of pegfilgrastim is mandatory in the induction treatment phase (BRd-regimen)for all patients experiencing severe neutropenia. The aim of this study is to achieve high quality response rates (CR, VGPR) of ≥ 40%. If this aim is achieved, the treatment of bendamustine in combination with the established lenalidomide/ dexamethasone regimen will be considered promising. Besides efficacy, the safety of this three-drug regimen is evaluated in this trial.

Detailed description

Assessments for efficacy / response evaluation: * M-protein quantitation in serum and 24 h urine collection samples by serum- and urine protein electrophoresis * Quantitation of immunoglobulin levels by nephelometry * Serum and urine immunofixation * Free light chain concentrations and ratio in the serum * Plasma cell percentage in the bone marrow by conventional cytology and biopsy with immunohistochemistry * Radiologic assessments of the skeleton Response criteria: Response will be assessed according to IMWG criteria

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Bendamustine	Induction treatment phase (cycle 1-6): * Bendamustine 75 mg/m2 i.v day 1 and 2 * Lenalidomide 25 mg p.o. day 1-21 * Dexamethasone 40/20 mg p.o., day 1, 8, 15, 22 * Pegfilgrastim 6 mg s.c., day 3 in case of severe neutropenia Maintenance treatment phase (cycles 7-18): * Lenalidomide 25 mg p.o. day 1-21 * Dexamethasone 40/20 mg p.o., day 1, 8, 15, 22

Timeline

• Start date: 2012-03-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2012-10-04
• Last updated: 2016-08-24

Locations

1 site across 1 country: Switzerland