Evidence map›Paper›PMID 31138244›Full record

ArticleBMC cancer2019

Rationale and design of the German-speaking myeloma multicenter group (GMMG) trial HD6: a randomized phase III trial on the effect of elotuzumab in VRD induction/consolidation and lenalidomide maintenance in patients with newly diagnosed myeloma.

Hans Salwender, Uta Bertsch, Katja Weisel, Jan Duerig, Christina Kunz, Axel Benner, Igor W Blau, Marc Steffen Raab, Jens Hillengass, Dirk Hose and 17 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02495922 (A Randomized Phase III Trial on the Effect of Elotuzumab in VRD Induction /Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
3.4field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02495922 phase3completednot on this map

A Randomized Phase III Trial on the Effect of Elotuzumab in VRD Induction /Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma

TypeinterventionalSponsorUniversity of Heidelberg Medical CenterRan2015 to 2021Enrolled564ConditionsMultiple MyelomaArmselotuzumab, Lenalidomide, Bortezomib, Dexamethasone
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.

  1. International Myeloma Society/International Myeloma Working Group Consensus Recommendations on the Definition of High-Risk Multiple Myeloma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
    Guideline
  2. Trial
  3. Trial
  4. Trial
  5. Endless possibilities and how to exploit them? What is the optimal treatment sequence?Hematology. American Society of Hematology. Education Program · 2025
    Review
  6. Impact of Clinical Parameters and Induction Regimens on Peripheral Blood Stem-Cell Mobilization and Collection in Multiple Myeloma Patients.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2023
    Article
  7. Article
  8. Review
  9. Article
  10. Review
  11. Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Roundtable: How I treat a newly diagnosed patient with high-risk myeloma.Hematology. American Society of Hematology. Education Program · 2019
    Article
  17. Meeting report of the 7th Heidelberg Myeloma Workshop: today and tomorrow.Journal of cancer research and clinical oncology · 2019
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors at 16 institutions in 1 country.

Hans SalwenderAsklepios Hospital Hamburg, Altona, Hematology, Oncology and Palliative Care, 22763, Hamburg, Germany. h.salwender@asklepios.com.ORCID http://orcid.org/0000-0001-7803-0814
Uta BertschUniversity Hospital Heidelberg, Heidelberg, Germany.
Katja WeiselUniversity Hospital Tuebingen, Tuebingen, Germany.
Jan DuerigUniversity Hospital Essen, Essen, Germany.
Christina KunzGerman Cancer Research Center Heidelberg, Heidelberg, Germany.
Axel BennerGerman Cancer Research Center Heidelberg, Heidelberg, Germany.
Igor W BlauCharité Universitaetsmedizin Berlin, Berlin, Germany.
Marc Steffen RaabUniversity Hospital Heidelberg, Heidelberg, Germany.
Jens HillengassUniversity Hospital Heidelberg, Heidelberg, Germany.
Dirk HoseUniversity Hospital Heidelberg, Heidelberg, Germany.
Stefanie HuhnUniversity Hospital Heidelberg, Heidelberg, Germany.
Michael HundemerUniversity Hospital Heidelberg, Heidelberg, Germany.
Mindaugas AndrulisInstitute of Pathology, Klinikum Ludwigshafen, Ludwigshafen am Rhein, Germany.
Anna JauchInstitute of Human Genetics, University of Heidelberg, Heidelberg, Germany.
Andrea Seidel-GlaetzerCordination Center for Clinical Trials, University of Heidelberg (KKS), Heidelberg, Germany.
Hans-Walter LindemannKath. Krankenhaus Hagen, Hagen, Germany.
Manfred HenselMannheimer Onkologie Praxis, Mannheim, Germany.
Stefan FronhoffsZentrum fuer ambulante Haematologie und Onkologie Siegburg, Siegburg, Germany.
Uwe MartensSLK Klinikum Heilbronn, Heilbronn, Germany.
Timon HansenUniversity Hospital Hamburg Eppendorf, Hamburg, Germany.
Mohammed WattadEv. Krankenhaus Essen-Werden, Essen, Germany.
Ullrich GraevenKrankenhaus Maria Hilf Moenchengladbach, Moenchengladbach, Germany.
Markus MunderUniversity Medical Center Mainz, Mainz, Germany.
Roland FenkUniversity Hospital Duesseldorf, Dusseldorf, Germany.
Mathias HaenelKlinikum Chemnitz, Chemnitz, Germany.
Christof ScheidUniversity Hospital Koeln, Cologne, Germany.
Hartmut GoldschmidtUniversity Hospital Heidelberg, Heidelberg, Germany.
Heidelberg University · DEGerman Cancer Research Center · DEUniversität Hamburg · DEAsklepios Klinik Altona · DECharité - Universitätsmedizin Berlin · DEDüsseldorf University Hospital · DEEssen University Hospital · DEFernUniversität in Hagen · DEHelios Hospital Siegburg · DEJohannes Gutenberg University Mainz · DEKliniken Maria Hilf · DEKlinikum Chemnitz · DEKlinikum Ludwigshafen · DEPraxis für Hämatologie und Onkologie · DESLK-Kliniken Heilbronn · DEUniversity Hospital Cologne · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDespite major advances in therapy, multiple myeloma is still an incurable malignancy in the majority of patients. To increase survival, deeper remissions (i.e. CR) translating into longer PFS need to be achieved. Incorporation of new drugs (i.e. bortezomib and lenalidomide) as induction and maintenance treatment in an intensified treatment concept, including high dose melphalan (200 mg/m

methodsGMMG-HD6 is a randomized, open, multicenter phase III trial. The planned recruitment number is 564 NDMM patients. All patients will receive 4 VRD cycles as induction and undergo peripheral blood stem cell mobilization and harvesting. Thereafter they will be treated with high dose melphalan therapy plus autologous stem cell transplantation followed by 2 cycles of VRD consolidation and lenalidomide maintenance. Patients in arm B1 + B2 will additionally receive elotuzumab in the induction phase, whereas patients in A2 + B2 will be treated with elotuzumab added to consolidation and maintenance. The primary endpoint of the trial is PFS. Secondary objectives and endpoints are OS, CR rates after induction therapy comparing the two arms VRD (A1 + A2) vs VRD + elotuzumab (B1 + B2), CR rates after consolidation treatment, best response to treatment during the study, time to progression (TTP), duration of response (DOR), toxicity and quality of life.

resultsSince this is the publication of a study protocol of an ongoing study, no results can be presented. DISCUSSION: This phase III trial is designed to evaluate whether the addition of elotuzumab to an intensified treatment concept with high dose melphalan chemotherapy plus autologous stem cell transplantation and induction, consolidation and maintenance treatment with bortezomib and lenalidomide is able to improve PFS compared to the same concept without elotuzumab.

trial registrationNCT02495922 on June 24th, 2015.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedBortezomibClinical Trials, Phase III as TopicConsolidation ChemotherapyDexamethasoneFemaleHematopoietic Stem Cell TransplantationHumansInduction ChemotherapyLenalidomideMaintenance ChemotherapyMaleMelphalanMiddle AgedAntibodies, Monoclonal, HumanizedBortezomibDexamethasoneelotuzumabLenalidomideMelphalanautologous stem cell transplantelotuzumabhigh-dose chemotherapyMultiple myeloma

Identifiers

PMID31138244
PMCPMC6537200
OpenAlexW2947217637

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.