A Phase III Trial on the Effect of Elotuzumab in VRD Induction /Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma (GMMG-HD6)

• ClinicalTrials.gov Identifier: NCT02495922
• Recruitment Status: Completed
• First Posted: July 13, 2015
• Last Update Posted: September 10, 2021
• Sponsor: University of Heidelberg Medical Center
• Information provided by (Responsible Party): Prof. Dr. Hartmut Goldschmidt, University of Heidelberg Medical Center

Study Description

Brief Summary:

Trial in patients with newly diagnosed myeloma to evaluate the effect of elotuzumab in induction and consolidation therapy with bortezomib/lenalidomide/dexamethasone and in lenalidomide maintenance treatment

Condition or disease	Intervention/treatment	Phase
Multiple Myeloma	Drug: elotuzumab; Drug: Lenalidomide; Drug: Bortezomib; Drug: Dexamethasone	Phase 3

Detailed Description:

Prospective, multicentre, randomised, parallel group, open, phase III clinical trial, for patients with confirmed diagnosis of untreated multiple myeloma requiring systemic therapy .

Investigational Medicinal Products:Elotuzumab, lenalidomide

Patients are randomized in one of 4 study arms (A1, A2, B1, B2). Patients randomized in arm A1 or A2 will receive 4 cycles VRD (Bortezomib (Velcade®), Lenalidomide (Revlimid®), Dexamethasone). Patients in arm B1 or B2 will additionally receive the monoclonal antibody Elotuzumab in the 4 cycles VRD. After induction therapy patients undergo intensifying therapy according to GMMG standard (usually mobilization therapy followed by stem cell collection and autologous stem cell transplantation). After intensification a consolidation therapy will be performed with two cycles VRD (A1 und B1) or VRD+ Elotuzumab (A2 und B2), followed by Lenalidomide maintenance therapy with (arm A2 and B2) or without (arm A1 and B1) additional Elotuzumab. Maintenance therapy will be performed for 2 years.

Primary objective is the determination of the best of four treatment strategies regarding progression-free survival (PFS), defined as time from randomisation to progression or death from any cause whichever occurs first.

The duration of the trial for each patients is expected to be 36-39 months (induction and intensification treatment: 7-10 months, 3 months rest between intensification and start of consolidation, consolidation 2 months, maintenance phase 24 months).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 564 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Phase III Trial on the Effect of Elotuzumab in VRD Induction /Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma
• Study Start Date: June 2015
• Actual Primary Completion Date: June 24, 2021
• Actual Study Completion Date: June 24, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: A1; Induction therapy with 4 cycles VRD (Velcade, Revlimid, Dexamethasone), 21 days per cycle, intensification (mobilization and autologous stem cell transplantation), consolidation therapy with 2 cycles VRD (Velcade, Revlimid, Dexamethasone), 21 days per cycle. Maintenance therapy: 26 cycles (28 days) with lenalidomide (Dexamethasone on day 1 and 15 in cycles 1-6 and on day 1 in cycles 7 to 26).	Drug: Lenalidomide; 25 mg per os on day 1-14 in induction cycle 1-4, 25 mg p.o. on day 1-14 in consolidation cycle 1 and 2, 10 mg p.o. on day 1-28 in maintenance cycle 1-3, 15 mg p.o. on day 1-28 in maintenance cycle 4-26 (all arms); Other Name: Revlimid; Drug: Bortezomib; all arms: 1,3 mg/m^2 subcutaneous on day 1, 4, 8 and 11 in 4 induction cycles, 1,3 mg/m^2 subcutaneous on day 1, 8 and 15 in 2 cycles of consolidation; Other Name: Velcade; Drug: Dexamethasone; 20 mg per os on day 1,2 and 4,5 and 8,9 and 11,12 and 15 in induction cycles 1 and 2. 20 mg per os on day 1,2 and 4,5 and 8,9 and 11,12 in induction cycles 3 and 4 (Arms A1 and A2). 8 mg per os and 12 mg i.v. on day 1, 8 and 15 and 20 mg per os on days 2,4,5, 9, 11 and 12 in induction cycles 1 and 2. 8 mg per os and 12 mg i.v. on day 1, and 11, 20 mg per os on days 2,4,5,8, 9, and 12 in induction cycles 3 and 4 (Arms B1 and B2). 20 mg per os on days 1,2, 8,9, 15 and 16 in both cycles of consolidation (Arms A1 and B1). 8 mg per os and 12 mg i.v. on days 1, 8 and 15 and 20 mg per os on days 2, 9 and 16 in both consolidation cycles (Arms A2 and B2). 12 mg per os on day 1 and 15 in maintenance cycles 1-6, 12 mg per os on day 1 of maintenance cycles 7 and following (Arms A1 and B1). 4 mg per os and 8 mg i.v. on day 1 and 15 in maintenance cycles 1-6, 4 mg per os and 8 mg i.v. on day 1 of maintenance cycles 7 and following (Arms A2 and B2).
Experimental: A2; Induction therapy with 4 cycles VRD (Velcade, Revlimid, Dexamethasone) 21 days per cycle, intensification (mobilization and autologous stem cell transplantation), consolidation therapy with 2 cycles VRD (Velcade, Revlimid, Dexamethasone) + elotuzumab, 21 days per cycle. Maintenance therapy: 26 cycles (28 days) with lenalidomide + elotuzumab (Dexamethasone on day 1 and 15 in cycles 1-6 and on day 1 in cycles 7 to 26).	Drug: elotuzumab; 10 mg/kg in the vein( i.v) on day 1,8 and 15 in induction cycle 1 and 2, on day 1 and 11 in induction cycle 3 and 4 (Arm B1 and B2). 10 mg/kg i.v. on day 1,8 and 15 in consolidation cycle 1 and 2 (Arm A2 and B2), 10 mg/kg i.v. on day 1 and15 in maintenance cycle 1-6, 10 mg/kg i.v. on day 1 in maintenance cycle 7-26 (Arm A2 and B2); Drug: Lenalidomide; 25 mg per os on day 1-14 in induction cycle 1-4, 25 mg p.o. on day 1-14 in consolidation cycle 1 and 2, 10 mg p.o. on day 1-28 in maintenance cycle 1-3, 15 mg p.o. on day 1-28 in maintenance cycle 4-26 (all arms); Other Name: Revlimid; Drug: Bortezomib; all arms: 1,3 mg/m^2 subcutaneous on day 1, 4, 8 and 11 in 4 induction cycles, 1,3 mg/m^2 subcutaneous on day 1, 8 and 15 in 2 cycles of consolidation; Other Name: Velcade; Drug: Dexamethasone; 20 mg per os on day 1,2 and 4,5 and 8,9 and 11,12 and 15 in induction cycles 1 and 2. 20 mg per os on day 1,2 and 4,5 and 8,9 and 11,12 in induction cycles 3 and 4 (Arms A1 and A2). 8 mg per os and 12 mg i.v. on day 1, 8 and 15 and 20 mg per os on days 2,4,5, 9, 11 and 12 in induction cycles 1 and 2. 8 mg per os and 12 mg i.v. on day 1, and 11, 20 mg per os on days 2,4,5,8, 9, and 12 in induction cycles 3 and 4 (Arms B1 and B2). 20 mg per os on days 1,2, 8,9, 15 and 16 in both cycles of consolidation (Arms A1 and B1). 8 mg per os and 12 mg i.v. on days 1, 8 and 15 and 20 mg per os on days 2, 9 and 16 in both consolidation cycles (Arms A2 and B2). 12 mg per os on day 1 and 15 in maintenance cycles 1-6, 12 mg per os on day 1 of maintenance cycles 7 and following (Arms A1 and B1). 4 mg per os and 8 mg i.v. on day 1 and 15 in maintenance cycles 1-6, 4 mg per os and 8 mg i.v. on day 1 of maintenance cycles 7 and following (Arms A2 and B2).
Experimental: B1; Induction therapy with 4 cycles VRD (Velcade, Revlimid, Dexamethasone) + elotuzumab , 21 days per cycle, intensification (mobilization and autologous stem cell transplantation), consolidation therapy with 2 cycles VRD (Velcade, Revlimid, Dexamethasone) 21 days per cycle. Maintenance therapy: 26 cycles (28 days) with lenalidomide (Dexamethasone on day 1 and 15 in cycles 1-6 and on day 1 in cycles 7 to 26).	Drug: elotuzumab; 10 mg/kg in the vein( i.v) on day 1,8 and 15 in induction cycle 1 and 2, on day 1 and 11 in induction cycle 3 and 4 (Arm B1 and B2). 10 mg/kg i.v. on day 1,8 and 15 in consolidation cycle 1 and 2 (Arm A2 and B2), 10 mg/kg i.v. on day 1 and15 in maintenance cycle 1-6, 10 mg/kg i.v. on day 1 in maintenance cycle 7-26 (Arm A2 and B2); Drug: Lenalidomide; 25 mg per os on day 1-14 in induction cycle 1-4, 25 mg p.o. on day 1-14 in consolidation cycle 1 and 2, 10 mg p.o. on day 1-28 in maintenance cycle 1-3, 15 mg p.o. on day 1-28 in maintenance cycle 4-26 (all arms); Other Name: Revlimid; Drug: Bortezomib; all arms: 1,3 mg/m^2 subcutaneous on day 1, 4, 8 and 11 in 4 induction cycles, 1,3 mg/m^2 subcutaneous on day 1, 8 and 15 in 2 cycles of consolidation; Other Name: Velcade; Drug: Dexamethasone; 20 mg per os on day 1,2 and 4,5 and 8,9 and 11,12 and 15 in induction cycles 1 and 2. 20 mg per os on day 1,2 and 4,5 and 8,9 and 11,12 in induction cycles 3 and 4 (Arms A1 and A2). 8 mg per os and 12 mg i.v. on day 1, 8 and 15 and 20 mg per os on days 2,4,5, 9, 11 and 12 in induction cycles 1 and 2. 8 mg per os and 12 mg i.v. on day 1, and 11, 20 mg per os on days 2,4,5,8, 9, and 12 in induction cycles 3 and 4 (Arms B1 and B2). 20 mg per os on days 1,2, 8,9, 15 and 16 in both cycles of consolidation (Arms A1 and B1). 8 mg per os and 12 mg i.v. on days 1, 8 and 15 and 20 mg per os on days 2, 9 and 16 in both consolidation cycles (Arms A2 and B2). 12 mg per os on day 1 and 15 in maintenance cycles 1-6, 12 mg per os on day 1 of maintenance cycles 7 and following (Arms A1 and B1). 4 mg per os and 8 mg i.v. on day 1 and 15 in maintenance cycles 1-6, 4 mg per os and 8 mg i.v. on day 1 of maintenance cycles 7 and following (Arms A2 and B2).
Experimental: B2; Induction therapy with 4 cycles VRD (Velcade, Revlimid, Dexamethasone) + elotuzumab, 21 days per cycle, intensification (mobilization and autologous stem cell transplantation), consolidation therapy with 2 cycles VRD (Velcade, Revlimid, Dexamethasone) + elotuzumab, 21 days per cycle. Maintenance therapy: 26 cycles (28 days) with lenalidomide + elotuzumab (Dexamethasone on day 1 and 15 in cycles 1-6 and on day 1 in cycles 7 to 26).	Drug: elotuzumab; 10 mg/kg in the vein( i.v) on day 1,8 and 15 in induction cycle 1 and 2, on day 1 and 11 in induction cycle 3 and 4 (Arm B1 and B2). 10 mg/kg i.v. on day 1,8 and 15 in consolidation cycle 1 and 2 (Arm A2 and B2), 10 mg/kg i.v. on day 1 and15 in maintenance cycle 1-6, 10 mg/kg i.v. on day 1 in maintenance cycle 7-26 (Arm A2 and B2); Drug: Lenalidomide; 25 mg per os on day 1-14 in induction cycle 1-4, 25 mg p.o. on day 1-14 in consolidation cycle 1 and 2, 10 mg p.o. on day 1-28 in maintenance cycle 1-3, 15 mg p.o. on day 1-28 in maintenance cycle 4-26 (all arms); Other Name: Revlimid; Drug: Bortezomib; all arms: 1,3 mg/m^2 subcutaneous on day 1, 4, 8 and 11 in 4 induction cycles, 1,3 mg/m^2 subcutaneous on day 1, 8 and 15 in 2 cycles of consolidation; Other Name: Velcade; Drug: Dexamethasone; 20 mg per os on day 1,2 and 4,5 and 8,9 and 11,12 and 15 in induction cycles 1 and 2. 20 mg per os on day 1,2 and 4,5 and 8,9 and 11,12 in induction cycles 3 and 4 (Arms A1 and A2). 8 mg per os and 12 mg i.v. on day 1, 8 and 15 and 20 mg per os on days 2,4,5, 9, 11 and 12 in induction cycles 1 and 2. 8 mg per os and 12 mg i.v. on day 1, and 11, 20 mg per os on days 2,4,5,8, 9, and 12 in induction cycles 3 and 4 (Arms B1 and B2). 20 mg per os on days 1,2, 8,9, 15 and 16 in both cycles of consolidation (Arms A1 and B1). 8 mg per os and 12 mg i.v. on days 1, 8 and 15 and 20 mg per os on days 2, 9 and 16 in both consolidation cycles (Arms A2 and B2). 12 mg per os on day 1 and 15 in maintenance cycles 1-6, 12 mg per os on day 1 of maintenance cycles 7 and following (Arms A1 and B1). 4 mg per os and 8 mg i.v. on day 1 and 15 in maintenance cycles 1-6, 4 mg per os and 8 mg i.v. on day 1 of maintenance cycles 7 and following (Arms A2 and B2).

Outcome Measures

Primary Outcome Measures :

1. the best of four treatment strategies regarding Progression Free Survival (PFS) [ Time Frame: time from randomization to progression or death from any cause whichever comes first, censored after two years of maintenance therapy (i.e. approx. after 36 months after randomisation) ]
   response evaluation

Secondary Outcome Measures :

1. overall survival [ Time Frame: time from randomisation to time of death from any cause. Patients still being alive at the time of the analysis will be censored at the date last known to be alive. (assessed up to 80 months) ]
   survival status
2. complete response rates after induction [ Time Frame: approx. after 3 months (after induction therapy) ]
   response evaluation
3. complete response rates after consolidation [ Time Frame: approx. after 9 months (after consolidation therapy) ]
   response evaluation
4. Progression Free Survival after end of trial [ Time Frame: time from randomisation to progression or death from any cause whichever comes first, censored at the end date of the trial (i.e. assessed up to 80 months) ]
   response evaluation
5. best response to treatment during the study [ Time Frame: response assessment after ca. 3 months, 4 months, 7 months, 9 months,11 months, 14 months, and subsequently every 3 months during maintenance treatment, up to 35 months after start of study treatment. ]
   response evaluation
6. time to progression, censored at end of the trial [ Time Frame: From date of randomization until the date of first documented progression, assessed up to 80 months ]
   Response evaluation
7. duration of response, censored at end of the trial [ Time Frame: assessed up to 80 months ]
   response evaluation
8. toxicity during induction treatment, consolidation and maintenance treatment with respect to adverse Events of CTCAE grade 3 or higher [ Time Frame: from first administration of study drug until 40 days after last administration of study drug or any drug of the study treatment or upon start of a new subsequent chemotherapy, whichever occurs first ]
   toxicity according CTCAE Version 4.0
9. Quality of Life assessment [ Time Frame: assessed at baseline, after ca. 3 months, 7 months, 9 months, subsequently every 6 months, up to 36 months ]
   Questionnaires EORTC-QLQC30 and EORTC-QLQMY20

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients meeting all of the following criteria will be considered for admission to the trial:
• Confirmed diagnosis of untreated multiple myeloma requiring systemic therapy (diagnostic criteria (IMWG updated criteria (2014) )

• Measurable disease, defined as any quantifiable monoclonal protein value, defined by at least one of the following three measurements:

  • Serum M-protein ≥ 10g/l (for IgA ≥ 5g/l)
  • Urine light-chain (M-protein) of ≥ 200 mg/24 hours
  • Serum FLC assay: involved FLC level ≥ 10 mg/dl provided sFLC ratio is abnormal
• Age 18 - 70 years inclusive
• WHO performance status 0-3 (WHO=3 is allowed only if caused by MM and not by co-morbid conditions)
• Negative pregnancy test at inclusion (women of childbearing potential)
• For all men and women of childbearing potential: patients must be willing and capable to use adequate contraception during the complete therapy. Patients must agree on the requirements regarding the lenalidomide pregnancy prevention programme described in chapter 6.

• All patients must

  • agree to abstain from donating blood while taking lenalidomide and for 28 days following discontinuation of lenalidomide therapy
  • agree not to share study drug lenalidomide with another person and to return all unused study drug to the investigator or pharmacist
• Ability of patient to understand character and individual consequences of the clinical trial
• Written informed consent (must be available before enrollment in the trial)

Exclusion Criteria:

• Patients presenting with any of the following criteria will not be included in the trial:
• Patient has known hypersensitivity to any drugs given in the protocol, notably bortezomib, lenalidomide, dexamethasone and elotuzumab or to any of the constituent compounds (incl. boron and mannitol).
• Systemic AL amyloidosis (except for AL amyloidosis of the skin or the bone marrow)
• Previous chemotherapy or radiotherapy during the past 5 years except local radiotherapy in case of local myeloma progression.
• Severe cardiac dysfunction (NYHA classification III-IV)
• Significant hepatic dysfunction (serum bilirubin ≥ 1,8mg/dl and/or ASAT and/or ALAT ≥ 2.5 times normal level), unless related to myeloma.
• Patients with renal insufficiency requiring hemodialysis
• HIV positivity
• Patients with active or history of hepatitis B or C
• Patients with active, uncontrolled infections
• Patients with peripheral neuropathy or neuropathic pain, CTC grade 2 or higher (as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0)
• Patients with a history of active malignancy during the past 5 years with the exception of basal cell carcinoma of the skin or stage 0 cervical carcinoma treated with curative intent
• Patients with acute diffuse infiltrative pulmonary and/or pericardial disease
• Autoimmune hemolytic anemia with positive Coombs test or immune thrombocytopenia
• Platelet count < 75 x 109/l, or, dependent on bone marrow infiltration by plasma cells, platelet count < 30 x 109/l (patients with platelet count < 75 x 109/l, but > 30 x 109/l may be eligible if percentage of plasma cells in bone marrow is ≥ 50%), (transfusion support within 14 days before the test is not allowed)
• Haemoglobin ≤ 8.0 g/dl, unless related to myeloma
• Absolute neutrophil count (ANC) < 1.0 x 10^9/l (the use of colony stimulating factors within 14 days before the test is not allowed), unless related to myeloma
• Pregnancy and lactation
• Participation in other clinical trials. This does not include long-term follow-up periods without active drug treatment of previous studies during the last 6 months.

No patients will be allowed to enrol in this trial more than once.

Contacts and Locations

Locations

Germany

Studienzentrum Aschaffenburg

Aschaffenburg, Germany, 63739

MVZ Onkologie gGmbH der Klinikum Mittelbaden gGmbH

Baden-Baden, Germany, 76532

HELIOS Klinikum, Klinik für Hämatologie, Onkologie und Immunologie

Berlin, Germany, 13125

Onkologisches MVZ Berlin Tegel

Berlin, Germany, 13507

Charité Campus Benjamin Franklin, III. Med. Abt. (Hämatologie/Onkologie)

Berlin, Germany, D-12200

Klinikum Bielefeld, Klinik für Hämatologie, Onkologie und Palliativmedizin

Bielefeld, Germany, D-33604

Studiengesellschaft Onkologie Bielefeld GbR

Bielefeld, Germany, D-33604

Hämatologisch-onkologische Schwerpunktpraxis

Bochum, Germany, 44787

Medizinische Universitätsklinik, Knappschaftskrankenhaus

Bochum, Germany, D-44892

Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III, Schwerpunkt Onkologie, Hämatologie und Rheumatologie

Bonn, Germany, 53105

ZAHO, Zentrum für ambulante Hämatologie und Onkologie

Bonn, Germany, 53113

Schwerpunktpraxis für Onkologie/Hämatologie

Bottrop, Germany, 46236

Klinikum Chemnitz GmbH, Innere Medizin III

Chemnitz, Germany, D-09116

Onkologisches Studienzentrum Darmstadt

Darmstadt, Germany, 64283

Klinikum Darmstadt, Med. Klinik V, Hämatologie/Onkologie

Darmstadt, Germany, D-64283

HELIOS St. Johannes Klinik, Akademisches Krankenhaus der Heinrich-Heine-Universität Düsseldorf

Duisburg, Germany, 47166

MVZ Düsseldorf GmbH

Dusseldorf, Germany, 40235

Sana Kliniken Düsseldorf GmbH

Düsseldorf, Germany, 40593

Universitätsklinikum Düsseldorf, Klinik für Hämatologie,Onkologie und Klin. Immunologie

Düsseldorf, Germany, D-40225

Universitätsklinik Erlangen

Erlangen, Germany, 91054

St.-Antonius-Hospital Klinik f. Hämatologie und Onkologie

Eschweiler, Germany, 52249

Universitätsklinikum Essen, Klinik für Hämatologie

Essen, Germany, D-45147

Ev. Krankenhaus Essen-Werden gGmbH, Zentrum für Innere Medizin, Klinik für Hämatologie, Onkologie und Stammzelltransplantation

Essen, Germany, D-45239

Centrum für Hämatologie und Onkologie Bethanien

Frankfurt am Main, Germany, 60389

Universitätsklinikum Frankfurt, Goethe-Universität Medizinische Klinik II

Frankfurt am Main, Germany, 60590

Agaplesion Markus Krankenhaus

Frankfurt/Main, Germany, 60431

Praxis und Tagesklinik Friedrichshafen

Friedrichshafen, Germany, 88045

Gemeinschaftspraxis Schmitt/Eulenbuch

Gerlingen, Germany, 70839

Justus-Liebig-Universität, Medizinische Klinik IV

Gießen, Germany, 35385

Kath. Krankenhaus Hagen gGmbH, Abt. Hämatologie/Onkologie

Hagen, Germany, D-58095

Universitätsklinikum Hamburg-Eppendorf, II - Med. Klinik und Poliklinik

Hamburg, Germany, D-20246

Asklepios Klinik Hamburg Altona, II. Med. Klinik

Hamburg, Germany, D-22763

Evangelisches Krankhaus Hamm gGmbH

Hamm, Germany, 59063

Onkologische Schwerpunktpraxis

Heidelberg, Germany, 69115

University Hospital Heidelberg, Med. Klinik V

Heidelberg, Germany, D-69120

Onkologische Schwerpunktpraxis

Heilbronn, Germany, 74072

SLK Kliniken Heilbronn, Med. Klinik III

Heilbronn, Germany, D-74078

Universitätsklinikum des Saarlandes, Innere Medizin I

Homburg, Germany, 66421

Westpfalz-Klinikum GmbH

Kaiserslautern, Germany, 67655

Onkologische Schwerpunktpraxis Karlsruhe

Karlsruhe, Germany, 76135

Onkologische Gemeinschaftspraxis Kassel

Kassel, Germany, 34119

Praxisklinik für Hämatologie und Onkologie

Koblenz, Germany, D-56068

Universitätsklinikum Köln, Klinik I - Innere Medizin

Köln, Germany, D-50937

Onkologisches Zentrum, Gemeinschaftspraxis f. Hämatologie u. Onkologie im Caritas KH

Lebach, Germany, 66822

Klinikum Lippe GmbH, Hämatologie-Onkologie

Lemgo, Germany, D-32657

Schwerpunktpraxis für Hämatologie und Onkologie

Ludwigsburg, Germany, 71636

Med. Klinik A, Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen am Rhein, Germany, 67063

Internistische Schwerpunktpraxis für Hämatologie und Onkologie

Mainz, Germany, 55122

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, III. Med. Klinik

Mainz, Germany, D-55131

III. Medizinische Klinik Hämatologie und Internistische Onkologie

Mannheim, Germany, 68167

Mannheimer Onkologie Praxis

Mannheim, Germany, D-68161

Philipps-Universität Marburg, Hämatologie/Onkologie/Immunologie

Marburg, Germany, 35032

Mühlenkreiskliniken (AöR) Johannes Wesling Klinikum Minden, Hämatologie/Onkologie, Hämostaseologie und Palliativmedizin

Minden, Germany, 32429

Krankenhaus Maria Hilf GmbH, Franziskuskrankenhaus, Med. Klinik I

Mönchengladbach, Germany, D-41063

Praxis für Hämatologie und internistische Onkologie

Oberhausen, Germany, 46145

Internistisch, Onkologische Gemeinschaftspraxis Dres. Balló

Offenbach, Germany, 63065

Onkologische Praxis Oldenburg

Oldenburg, Germany, 26121

Krankenhaus Barmherzige Brüder, Klinik für Onkologie und Hämatologie

Regensburg, Germany, 93049

Klinikum am Steinenberg, Ermstalklinik, Medizinische Klinik I

Reutlingen, Germany, 72764

Diakonie-Klinikum Schwäbisch Hall gGmbH, Innere Medizin III

Schwäbisch Hall, Germany, 74523

ZAHO-Zentrum für ambulante Hämatologie und Onkologie, Standort Siegburg

Siegburg, Germany, D-53721

Diakonie Klinikum Jung-Stilling-Krankenhaus, Medizinische Klinik

Siegen, Germany, 57074

Onkologische Schwerpunktpraxis für Onkologie und Gastroenterologie

Singen, Germany, 78224

Onkologische Schwerpunktpraxis Speyer

Speyer, Germany, D-67346

Klinikum Mutterhaus der Borromäerinnen gGmbH

Trier, Germany, 54290

University Hospital Tübingen, Med. Klinik und Poliklinik, Abt. II

Tübingen, Germany, D-72076

Schwarzwald-Baar Klinikum, Klinik für Innere Medizin II

Villingen-Schwenningen, Germany, 78052

Rems-Murr-Klinikum gGmbH Winnenden

Winnenden, Germany, 71364

Sponsors and Collaborators

University of Heidelberg Medical Center

Investigators

• Principal Investigator: Hartmut Goldschmidt, Prof. Dr.; Med. Klinik V, University Hospital Heidelberg

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Salwender H, Bertsch U, Weisel K, Duerig J, Kunz C, Benner A, Blau IW, Raab MS, Hillengass J, Hose D, Huhn S, Hundemer M, Andrulis M, Jauch A, Seidel-Glaetzer A, Lindemann HW, Hensel M, Fronhoffs S, Martens U, Hansen T, Wattad M, Graeven U, Munder M, Fenk R, Haenel M, Scheid C, Goldschmidt H. 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. BMC Cancer. 2019 May 28;19(1):504. doi: 10.1186/s12885-019-5600-x.

• Responsible Party: Prof. Dr. Hartmut Goldschmidt, Prof. Dr., University of Heidelberg Medical Center
• ClinicalTrials.gov Identifier: NCT02495922
• Other Study ID Numbers: GMMG HD6
• First Posted: July 13, 2015
• Last Update Posted: September 10, 2021
• Last Verified: September 2021

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Dexamethasone; Lenalidomide; Bortezomib; Elotuzumab; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Immunologic Factors