Multiple Myeloma Clinical Trial
Official title:
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
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.
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
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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