Universität zu Köln

Baertsch, Marc-Andrea, Schlenzka, Jana, Mai, Elias K., Merz, Maximilian, Hillengass, Jens, Raab, Marc S., Hose, Dirk, Wuchter, Patrick, Ho, Anthony D. ORCID: 0000-0002-1656-0833, Jauch, Anna, Hielscher, Thomas, Kunz, Christina, Luntz, Steffen, Klein, Stefan, Schmidt-Wolf, Ingo G. H., Goerner, Martin, Schmidt-Hieber, Martin, Reimer, Peter, Graeven, Ullrich, Fenk, Roland, Salwender, Hans ORCID: 0000-0001-7803-0814, Scheid, Christof, Nogai, Axel, Haenel, Mathias, Lindemann, Hans W., Martin, Hans, Noppeney, Richard, Weisel, Katja and Goldschmidt, Hartmut (2016). Rationale and design of the German-Speaking Myeloma Multicenter Group (GMMG) trial ReLApsE: a randomized, open, multicenter phase III trial of lenalidomide/dexamethasone versus lenalidomide/dexamethasone plus subsequent autologous stem cell transplantation and lenalidomide maintenance in patients with relapsed multiple myeloma. BMC Cancer, 16. LONDON: BMC. ISSN 1471-2407

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Abstract

Background: Despite novel therapeutic agents, most multiple myeloma (MM) patients eventually relapse. Two large phase III trials have shown significantly improved response rates (RR) of lenalidomide/dexamethasone compared with placebo/dexamethasone in relapsed MM (RMM) patients. These results have led to the approval of lenalidomide for RMM patients and lenalidomide/dexamethasone has since become a widely accepted second-line treatment. Furthermore, in RMM patients consolidation with high-dose chemotherapy plus autologous stem cell transplantation has been shown to significantly increase progression free survival (PFS) as compared to cyclophosphamide in a phase III trial. The randomized prospective ReLApsE trial is designed to evaluate PFS after lenalidomide/dexamethasone induction, high-dose chemotherapy consolidation plus autologous stem cell transplantation and lenalidomide maintenance compared with the well-established lenalidomide/dexamethasone regimen in RMM patients. Methods/Design: ReLApsE is a randomized, open, multicenter phase III trial in a planned study population of 282 RMM patients. All patients receive three lenalidomide/dexamethasone cycles and -in absence of available stem cells from earlier harvesting - undergo peripheral blood stem cell mobilization and harvesting. Subsequently, patients in arm A continue on consecutive lenalidomide/dexamethasone cycles, patients in arm B undergo high dose chemotherapy plus autologous stem cell transplantation followed by lenalidomide maintenance until discontinuation criteria are met. Therapeutic response is evaluated after the 3rd (arm A + B) and the 5th lenalidomide/dexamethasone cycle (arm A) or 2 months after autologous stem cell transplantation (arm B) and every 3 months thereafter (arm A + B). After finishing the study treatment, patients are followed up for survival and subsequent myeloma therapies. The expected trial duration is 6.25 years from first patient in to last patient out. The primary endpoint is PFS, secondary endpoints include overall survival (OS), RR, time to best response and the influence of early versus late salvage high dose chemotherapy plus autologous stem cell transplantation on OS. Discussion: This phase III trial is designed to evaluate whether high dose chemotherapy plus autologous stem cell transplantation and lenalidomide maintenance after lenalidomide/dexamethasone induction improves PFS compared with the well-established continued lenalidomide/dexamethasone regimen in RMM patients.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Baertsch, Marc-Andrea UNSPECIFIED UNSPECIFIED UNSPECIFIED Schlenzka, Jana UNSPECIFIED UNSPECIFIED UNSPECIFIED Mai, Elias K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Merz, Maximilian UNSPECIFIED UNSPECIFIED UNSPECIFIED Hillengass, Jens UNSPECIFIED UNSPECIFIED UNSPECIFIED Raab, Marc S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hose, Dirk UNSPECIFIED UNSPECIFIED UNSPECIFIED Wuchter, Patrick UNSPECIFIED UNSPECIFIED UNSPECIFIED Ho, Anthony D. UNSPECIFIED orcid.org/0000-0002-1656-0833 UNSPECIFIED Jauch, Anna UNSPECIFIED UNSPECIFIED UNSPECIFIED Hielscher, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Kunz, Christina UNSPECIFIED UNSPECIFIED UNSPECIFIED Luntz, Steffen UNSPECIFIED UNSPECIFIED UNSPECIFIED Klein, Stefan UNSPECIFIED UNSPECIFIED UNSPECIFIED Schmidt-Wolf, Ingo G. H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Goerner, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Schmidt-Hieber, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Reimer, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Graeven, Ullrich UNSPECIFIED UNSPECIFIED UNSPECIFIED Fenk, Roland UNSPECIFIED UNSPECIFIED UNSPECIFIED Salwender, Hans UNSPECIFIED orcid.org/0000-0001-7803-0814 UNSPECIFIED Scheid, Christof UNSPECIFIED UNSPECIFIED UNSPECIFIED Nogai, Axel UNSPECIFIED UNSPECIFIED UNSPECIFIED Haenel, Mathias UNSPECIFIED UNSPECIFIED UNSPECIFIED Lindemann, Hans W. UNSPECIFIED UNSPECIFIED UNSPECIFIED Martin, Hans UNSPECIFIED UNSPECIFIED UNSPECIFIED Noppeney, Richard UNSPECIFIED UNSPECIFIED UNSPECIFIED Weisel, Katja UNSPECIFIED UNSPECIFIED UNSPECIFIED Goldschmidt, Hartmut UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-278330
DOI:	10.1186/s12885-016-2321-2
Journal or Publication Title:	BMC Cancer
Volume:	16
Date:	2016
Publisher:	BMC
Place of Publication:	LONDON
ISSN:	1471-2407
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language HIGH-DOSE THERAPY; SALVAGE THERAPY; THALIDOMIDE ANALOGS; STAGING SYSTEM; UP-FRONT; DEXAMETHASONE; SURVIVAL; BLOOD; RECOMMENDATIONS; EXPRESSION Multiple languages Oncology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/27833