Format

Send to

Choose Destination
Leukemia. 2020 Feb 7. doi: 10.1038/s41375-020-0724-1. [Epub ahead of print]

Response-adapted lenalidomide maintenance in newly diagnosed myeloma: results from the phase III GMMG-MM5 trial.

Author information

1
Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany. hartmut.goldschmidt@med.uni-heidelberg.de.
2
National Center for Tumor Diseases (NCT), Heidelberg, Germany. hartmut.goldschmidt@med.uni-heidelberg.de.
3
Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.
4
Department of Hematology, University Hospital Essen, Essen, Germany.
5
Department of Internal Medicine I, University Hospital Cologne, Cologne, Germany.
6
Department of Hematology, Oncology and Immunology, University Hospital Tübingen, Tübingen, Germany.
7
Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
8
Division of Biostatistics, German Cancer Research Center (DKFZ), Heidelberg, Germany.
9
National Center for Tumor Diseases (NCT), Heidelberg, Germany.
10
Department of Internal Medicine III, University Medical Center Mainz, Mainz, Germany.
11
Department of Hematology and Oncology, Katholisches Krankenhaus Hagen, Hagen, Germany.
12
Coordination Centre for Clinical Trials (KKS), Heidelberg, Germany.
13
Institute of Human Genetics, University of Heidelberg, Heidelberg, Germany.
14
Department of Hematology and Oncology, Asklepios Hospital Hamburg St. Georg, Hamburg, Germany.
15
Department of Hematology and Oncology, Helios Hospital Berlin Buch, Berlin, Germany.
16
University Hospital Bonn, Bonn, Germany.
17
Department of Hematology, Oncology and Palliative Care, Klinikum Bielefeld, Bielefeld, Germany.
18
Internal Medicine V, Klinikum Darmstadt, Darmstadt, Germany.
19
Medical Clinic A, Klinikum Ludwigshafen, Ludwigshafen, Germany.
20
Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
21
Medical Clinic, Charité University Medicine Berlin, Berlin, Germany.
22
Department of Internal Medicine III, Klinikum Chemnitz, Chemnitz, Germany.
23
Department of Hematology and Oncology, Asklepios Hospital Hamburg Altona, Hamburg, Germany.

Abstract

The MM5 trial aimed at demonstrating a progression-free survival (PFS) difference in continued vs. response-adapted (in case of complete response, CR) lenalidomide (LEN) maintenance therapy (MT) in newly diagnosed, transplant-eligible multiple myeloma (MM). Patients were equally randomized to receive induction therapy with PAd (bortezomib/doxorubicin/dexamethasone) or VCD (bortezomib/cyclophosphamide/dexamethasone), high-dose melphalan and autologous blood stem cell transplantation, and LEN consolidation, followed by either LEN MT for a fixed duration of 2 years (LEN-2Y) or until achievement of CR (LEN-CR, intention-to-treat population n = 502): arms A1:PAd + LEN-2Y (n = 125), B1:PAd + LEN-CR (n = 126), A2:VCD + LEN-2Y (n = 126), B2:VCD + LEN-CR (n = 125). In the LEN-CR group (B1 + B2), n = 88/17.5% patients did not start or discontinued LEN MT due to CR. There was no PFS (p = 0.60, primary endpoint) nor overall survival (OS) (p = 0.15) difference between the four study arms. On pooled LEN MT strategies, OS (hazard ratio, hazard ratio [HR] = 1.42, p = 0.03) but not PFS (HR = 1.15, p = 0.20) was shorter in LEN-CR (B1 + B2) vs. LEN-2Y (A1 + A2) groups. PFS was shortened on landmark analyses from the start of LEN MT in patients being in CR in the LEN-CR group (LEN-CR vs. LEN-2Y, HR = 1.84, p = 0.02). OS from first progression was shortened in the LEN-CR vs. LEN-2Y group (HR = 1.60, p = 0.01). LEN MT should be applied beyond CR for at least 2 years.

PMID:
32034285
DOI:
10.1038/s41375-020-0724-1

Supplemental Content

Full text links

Icon for Nature Publishing Group
Loading ...
Support Center