EHA Library - The official digital education library of European Hematology Association (EHA)

REVLIMID, BENDAMUSTINE AND PREDNISOLONE (RBP) IN RELAPSED/REFRACTORY MULTIPLE MYELOMA: FINAL RESULTS OF A PHASE II CLINICAL TRIAL; OSHO – #077
Author(s): ,
Juliane Beck
Affiliations:
Hematology,University Hospital Leipzig,Leipzig,Germany
,
Simone Heyn
Affiliations:
Hematology,University Hospital Leipzig,Leipzig,Germany
,
Dietrich Gläser
Affiliations:
Hematology,Südstadt Hospital Rostock,Rostock,Germany
,
Andreas Schwarzer
Affiliations:
Hematology,Hematology Practice Park-Krankenhaus Leipzig,Leipzig-Probstheida,Germany
,
Lars-Olof Mügge
Affiliations:
Hematology,University Hospital Jena,Jena,Germany
,
Jens Uhlig
Affiliations:
Hematology,Private Practice,Naunhof,Germany
,
Brigitte Kragl
Affiliations:
Hematology,University Hospital Rostock,Rostock,Germany
,
Martin Mohren
Affiliations:
Hematology,Hospital Stendal,Stendal,Germany
,
Franz Albert Hoffmann
Affiliations:
Hematology,Private Practice,Leipzig,Germany
,
Thoralf Lange
Affiliations:
Hematology,Hospital Weissenfels,Weissenfels,Germany
,
Thomas Schliwa
Affiliations:
Hematology,University Hospital Leipzig,Leipzig,Germany
,
Thomas Zehrfeld
Affiliations:
Hematology,Hospital Torgau,Torgau,Germany
,
Kreibich Ute
Affiliations:
Hematology,Heinrich Braun Hospital Zwickau,Zwickau,Germany
,
Cornelia Winkelmann
Affiliations:
Hematology,Hospital Wittenberg,Wittenberg,Germany
,
Thomas Edelmann
Affiliations:
Hematology,Private Practice,Schkeuditz,Germany
,
Marc Andrea
Affiliations:
Hematology,University Hospital Leipzig,Leipzig,Germany
,
Madlen Jentzsch
Affiliations:
Hematology,University Hospital Leipzig,Leipzig,Germany
,
Sebastian Schwind
Affiliations:
Hematology,University Hospital Leipzig,Leipzig,Germany
,
Cornelia Becker
Affiliations:
Hematology,Private Practice,Leipzig,Germany
,
Dietger Niederwieser
Affiliations:
Hematology,University Hospital Leipzig,Leipzig,Germany
Wolfram Poenisch
Affiliations:
Hematology,University Hospital Leipzig,Leipzig,Germany
(Abstract release date: 05/19/16) EHA Library. Beck J. 06/09/16; 132865; E1316
Mrs. Juliane Beck
Mrs. Juliane Beck
Contributions
Abstract
Abstract: E1316

Type: Eposter Presentation

Background
While the role of lenalidomide monotherapy in the treatment of relapsed/refractory patients with multiple myeloma (MM) is well established, combination therapies with lenalidomide are still under investigation in many phase 2/3 studies.

Aims
In the current study, a combination therapy of lenalinomide (Revlimid®), bendamustine and prednisolone (RBP) was tested in patients with relapsed or refractory MM. 

Methods
In the previously completed phase 1 study RPB with a dose of 25 mg lenalidomide d 1-21 and 75 mg/m² bendamustine d 1-2 was well tolerated in patients with relapsed/refractory MM (Pönisch et al. 2013). The treatment was repeated every 28 days for a maximum of eight cycles. Thereafter, patients received a maintenance therapy with 10 mg lenalidomide over 10 cycles.

Results
25 patients (19 patients of the phase 2 study and additional 6 patients from the highest dose level of the phase 1 study) were included in this analysis. Twenty two patients (88%) responded after at least two cycles of RBP with 1 sCR, 5 nCR, 8 VGPR and 8 PR. Due to increased haematological toxicity a dose reduction was required in subsequent therapy cycles in the most of all patients. 19 patients discontinued the treatment prematurely due to a stem cell transplantation (n=7), hematological toxicity (n=7), non hematological toxicity (n=3) or progress (n=2). The median progression-free and overall survival was 22 and 38 months, respectively.

Conclusion
RBP is a highly effective therapy for patients with relapsed or refractory MM. However, dose reduction is necessary in many patients because an increased haematological toxicity rate.

Session topic: E-poster

Keyword(s): Bendamustine, Imids, Multiple myeloma
Abstract: E1316

Type: Eposter Presentation

Background
While the role of lenalidomide monotherapy in the treatment of relapsed/refractory patients with multiple myeloma (MM) is well established, combination therapies with lenalidomide are still under investigation in many phase 2/3 studies.

Aims
In the current study, a combination therapy of lenalinomide (Revlimid®), bendamustine and prednisolone (RBP) was tested in patients with relapsed or refractory MM. 

Methods
In the previously completed phase 1 study RPB with a dose of 25 mg lenalidomide d 1-21 and 75 mg/m² bendamustine d 1-2 was well tolerated in patients with relapsed/refractory MM (Pönisch et al. 2013). The treatment was repeated every 28 days for a maximum of eight cycles. Thereafter, patients received a maintenance therapy with 10 mg lenalidomide over 10 cycles.

Results
25 patients (19 patients of the phase 2 study and additional 6 patients from the highest dose level of the phase 1 study) were included in this analysis. Twenty two patients (88%) responded after at least two cycles of RBP with 1 sCR, 5 nCR, 8 VGPR and 8 PR. Due to increased haematological toxicity a dose reduction was required in subsequent therapy cycles in the most of all patients. 19 patients discontinued the treatment prematurely due to a stem cell transplantation (n=7), hematological toxicity (n=7), non hematological toxicity (n=3) or progress (n=2). The median progression-free and overall survival was 22 and 38 months, respectively.

Conclusion
RBP is a highly effective therapy for patients with relapsed or refractory MM. However, dose reduction is necessary in many patients because an increased haematological toxicity rate.

Session topic: E-poster

Keyword(s): Bendamustine, Imids, Multiple myeloma

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