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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
elotuzumab
Lenalidomide
Bortezomib
Dexamethasone
Sponsored by
University of Heidelberg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Studienzentrum Aschaffenburg
  • MVZ Onkologie gGmbH der Klinikum Mittelbaden gGmbH
  • HELIOS Klinikum, Klinik für Hämatologie, Onkologie und Immunologie
  • Onkologisches MVZ Berlin Tegel
  • Charité Campus Benjamin Franklin, III. Med. Abt. (Hämatologie/Onkologie)
  • Klinikum Bielefeld, Klinik für Hämatologie, Onkologie und Palliativmedizin
  • Studiengesellschaft Onkologie Bielefeld GbR
  • Hämatologisch-onkologische Schwerpunktpraxis
  • Medizinische Universitätsklinik, Knappschaftskrankenhaus
  • Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III, Schwerpunkt Onkologie, Hämatologie und Rheumatologie
  • ZAHO, Zentrum für ambulante Hämatologie und Onkologie
  • Schwerpunktpraxis für Onkologie/Hämatologie
  • Klinikum Chemnitz GmbH, Innere Medizin III
  • Onkologisches Studienzentrum Darmstadt
  • Klinikum Darmstadt, Med. Klinik V, Hämatologie/Onkologie
  • HELIOS St. Johannes Klinik, Akademisches Krankenhaus der Heinrich-Heine-Universität Düsseldorf
  • MVZ Düsseldorf GmbH
  • Sana Kliniken Düsseldorf GmbH
  • Universitätsklinikum Düsseldorf, Klinik für Hämatologie,Onkologie und Klin. Immunologie
  • Universitätsklinik Erlangen
  • St.-Antonius-Hospital Klinik f. Hämatologie und Onkologie
  • Universitätsklinikum Essen, Klinik für Hämatologie
  • Ev. Krankenhaus Essen-Werden gGmbH, Zentrum für Innere Medizin, Klinik für Hämatologie, Onkologie und Stammzelltransplantation
  • Centrum für Hämatologie und Onkologie Bethanien
  • Universitätsklinikum Frankfurt, Goethe-Universität Medizinische Klinik II
  • Agaplesion Markus Krankenhaus
  • Praxis und Tagesklinik Friedrichshafen
  • Gemeinschaftspraxis Schmitt/Eulenbuch
  • Justus-Liebig-Universität, Medizinische Klinik IV
  • Kath. Krankenhaus Hagen gGmbH, Abt. Hämatologie/Onkologie
  • Universitätsklinikum Hamburg-Eppendorf, II - Med. Klinik und Poliklinik
  • Asklepios Klinik Hamburg Altona, II. Med. Klinik
  • Evangelisches Krankhaus Hamm gGmbH
  • Onkologische Schwerpunktpraxis
  • University Hospital Heidelberg, Med. Klinik V
  • Onkologische Schwerpunktpraxis
  • SLK Kliniken Heilbronn, Med. Klinik III
  • Universitätsklinikum des Saarlandes, Innere Medizin I
  • Westpfalz-Klinikum GmbH
  • Onkologische Schwerpunktpraxis Karlsruhe
  • Onkologische Gemeinschaftspraxis Kassel
  • Praxisklinik für Hämatologie und Onkologie
  • Universitätsklinikum Köln, Klinik I - Innere Medizin
  • Onkologisches Zentrum, Gemeinschaftspraxis f. Hämatologie u. Onkologie im Caritas KH
  • Klinikum Lippe GmbH, Hämatologie-Onkologie
  • Schwerpunktpraxis für Hämatologie und Onkologie
  • Med. Klinik A, Klinikum der Stadt Ludwigshafen am Rhein gGmbH
  • Internistische Schwerpunktpraxis für Hämatologie und Onkologie
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, III. Med. Klinik
  • III. Medizinische Klinik Hämatologie und Internistische Onkologie
  • Mannheimer Onkologie Praxis
  • Philipps-Universität Marburg, Hämatologie/Onkologie/Immunologie
  • Mühlenkreiskliniken (AöR) Johannes Wesling Klinikum Minden, Hämatologie/Onkologie, Hämostaseologie und Palliativmedizin
  • Krankenhaus Maria Hilf GmbH, Franziskuskrankenhaus, Med. Klinik I
  • Praxis für Hämatologie und internistische Onkologie
  • Internistisch, Onkologische Gemeinschaftspraxis Dres. Balló
  • Onkologische Praxis Oldenburg
  • Krankenhaus Barmherzige Brüder, Klinik für Onkologie und Hämatologie
  • Klinikum am Steinenberg, Ermstalklinik, Medizinische Klinik I
  • Diakonie-Klinikum Schwäbisch Hall gGmbH, Innere Medizin III
  • ZAHO-Zentrum für ambulante Hämatologie und Onkologie, Standort Siegburg
  • Diakonie Klinikum Jung-Stilling-Krankenhaus, Medizinische Klinik
  • Onkologische Schwerpunktpraxis für Onkologie und Gastroenterologie
  • Onkologische Schwerpunktpraxis Speyer
  • Klinikum Mutterhaus der Borromäerinnen gGmbH
  • University Hospital Tübingen, Med. Klinik und Poliklinik, Abt. II
  • Schwarzwald-Baar Klinikum, Klinik für Innere Medizin II
  • Rems-Murr-Klinikum gGmbH Winnenden

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

A1

A2

B1

B2

Arm Description

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).

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).

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).

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).

Outcomes

Primary Outcome Measures

the best of four treatment strategies regarding Progression Free Survival (PFS)
response evaluation

Secondary Outcome Measures

overall survival
survival status
complete response rates after induction
response evaluation
complete response rates after consolidation
response evaluation
Progression Free Survival after end of trial
response evaluation
best response to treatment during the study
response evaluation
time to progression, censored at end of the trial
Response evaluation
duration of response, censored at end of the trial
response evaluation
toxicity during induction treatment, consolidation and maintenance treatment with respect to adverse Events of CTCAE grade 3 or higher
toxicity according CTCAE Version 4.0
Quality of Life assessment
Questionnaires EORTC-QLQC30 and EORTC-QLQMY20

Full Information

First Posted
June 24, 2015
Last Updated
September 9, 2021
Sponsor
University of Heidelberg Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02495922
Brief Title
A Phase III Trial on the Effect of Elotuzumab in VRD Induction /Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma
Acronym
GMMG-HD6
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 Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 24, 2021 (Actual)
Study Completion Date
June 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Heidelberg Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
564 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A1
Arm Type
Active Comparator
Arm Description
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).
Arm Title
A2
Arm Type
Experimental
Arm Description
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).
Arm Title
B1
Arm Type
Experimental
Arm Description
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).
Arm Title
B2
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
elotuzumab
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Velcade
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
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).
Primary Outcome Measure Information:
Title
the best of four treatment strategies regarding Progression Free Survival (PFS)
Description
response evaluation
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)
Secondary Outcome Measure Information:
Title
overall survival
Description
survival status
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)
Title
complete response rates after induction
Description
response evaluation
Time Frame
approx. after 3 months (after induction therapy)
Title
complete response rates after consolidation
Description
response evaluation
Time Frame
approx. after 9 months (after consolidation therapy)
Title
Progression Free Survival after end of trial
Description
response evaluation
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)
Title
best response to treatment during the study
Description
response evaluation
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.
Title
time to progression, censored at end of the trial
Description
Response evaluation
Time Frame
From date of randomization until the date of first documented progression, assessed up to 80 months
Title
duration of response, censored at end of the trial
Description
response evaluation
Time Frame
assessed up to 80 months
Title
toxicity during induction treatment, consolidation and maintenance treatment with respect to adverse Events of CTCAE grade 3 or higher
Description
toxicity according CTCAE Version 4.0
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
Title
Quality of Life assessment
Description
Questionnaires EORTC-QLQC30 and EORTC-QLQMY20
Time Frame
assessed at baseline, after ca. 3 months, 7 months, 9 months, subsequently every 6 months, up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hartmut Goldschmidt, Prof. Dr.
Organizational Affiliation
Med. Klinik V, University Hospital Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Studienzentrum Aschaffenburg
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
MVZ Onkologie gGmbH der Klinikum Mittelbaden gGmbH
City
Baden-Baden
ZIP/Postal Code
76532
Country
Germany
Facility Name
HELIOS Klinikum, Klinik für Hämatologie, Onkologie und Immunologie
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Onkologisches MVZ Berlin Tegel
City
Berlin
ZIP/Postal Code
13507
Country
Germany
Facility Name
Charité Campus Benjamin Franklin, III. Med. Abt. (Hämatologie/Onkologie)
City
Berlin
ZIP/Postal Code
D-12200
Country
Germany
Facility Name
Klinikum Bielefeld, Klinik für Hämatologie, Onkologie und Palliativmedizin
City
Bielefeld
ZIP/Postal Code
D-33604
Country
Germany
Facility Name
Studiengesellschaft Onkologie Bielefeld GbR
City
Bielefeld
ZIP/Postal Code
D-33604
Country
Germany
Facility Name
Hämatologisch-onkologische Schwerpunktpraxis
City
Bochum
ZIP/Postal Code
44787
Country
Germany
Facility Name
Medizinische Universitätsklinik, Knappschaftskrankenhaus
City
Bochum
ZIP/Postal Code
D-44892
Country
Germany
Facility Name
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III, Schwerpunkt Onkologie, Hämatologie und Rheumatologie
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
ZAHO, Zentrum für ambulante Hämatologie und Onkologie
City
Bonn
ZIP/Postal Code
53113
Country
Germany
Facility Name
Schwerpunktpraxis für Onkologie/Hämatologie
City
Bottrop
ZIP/Postal Code
46236
Country
Germany
Facility Name
Klinikum Chemnitz GmbH, Innere Medizin III
City
Chemnitz
ZIP/Postal Code
D-09116
Country
Germany
Facility Name
Onkologisches Studienzentrum Darmstadt
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Facility Name
Klinikum Darmstadt, Med. Klinik V, Hämatologie/Onkologie
City
Darmstadt
ZIP/Postal Code
D-64283
Country
Germany
Facility Name
HELIOS St. Johannes Klinik, Akademisches Krankenhaus der Heinrich-Heine-Universität Düsseldorf
City
Duisburg
ZIP/Postal Code
47166
Country
Germany
Facility Name
MVZ Düsseldorf GmbH
City
Dusseldorf
ZIP/Postal Code
40235
Country
Germany
Facility Name
Sana Kliniken Düsseldorf GmbH
City
Düsseldorf
ZIP/Postal Code
40593
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf, Klinik für Hämatologie,Onkologie und Klin. Immunologie
City
Düsseldorf
ZIP/Postal Code
D-40225
Country
Germany
Facility Name
Universitätsklinik Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
St.-Antonius-Hospital Klinik f. Hämatologie und Onkologie
City
Eschweiler
ZIP/Postal Code
52249
Country
Germany
Facility Name
Universitätsklinikum Essen, Klinik für Hämatologie
City
Essen
ZIP/Postal Code
D-45147
Country
Germany
Facility Name
Ev. Krankenhaus Essen-Werden gGmbH, Zentrum für Innere Medizin, Klinik für Hämatologie, Onkologie und Stammzelltransplantation
City
Essen
ZIP/Postal Code
D-45239
Country
Germany
Facility Name
Centrum für Hämatologie und Onkologie Bethanien
City
Frankfurt am Main
ZIP/Postal Code
60389
Country
Germany
Facility Name
Universitätsklinikum Frankfurt, Goethe-Universität Medizinische Klinik II
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Agaplesion Markus Krankenhaus
City
Frankfurt/Main
ZIP/Postal Code
60431
Country
Germany
Facility Name
Praxis und Tagesklinik Friedrichshafen
City
Friedrichshafen
ZIP/Postal Code
88045
Country
Germany
Facility Name
Gemeinschaftspraxis Schmitt/Eulenbuch
City
Gerlingen
ZIP/Postal Code
70839
Country
Germany
Facility Name
Justus-Liebig-Universität, Medizinische Klinik IV
City
Gießen
ZIP/Postal Code
35385
Country
Germany
Facility Name
Kath. Krankenhaus Hagen gGmbH, Abt. Hämatologie/Onkologie
City
Hagen
ZIP/Postal Code
D-58095
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf, II - Med. Klinik und Poliklinik
City
Hamburg
ZIP/Postal Code
D-20246
Country
Germany
Facility Name
Asklepios Klinik Hamburg Altona, II. Med. Klinik
City
Hamburg
ZIP/Postal Code
D-22763
Country
Germany
Facility Name
Evangelisches Krankhaus Hamm gGmbH
City
Hamm
ZIP/Postal Code
59063
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
University Hospital Heidelberg, Med. Klinik V
City
Heidelberg
ZIP/Postal Code
D-69120
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis
City
Heilbronn
ZIP/Postal Code
74072
Country
Germany
Facility Name
SLK Kliniken Heilbronn, Med. Klinik III
City
Heilbronn
ZIP/Postal Code
D-74078
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes, Innere Medizin I
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Westpfalz-Klinikum GmbH
City
Kaiserslautern
ZIP/Postal Code
67655
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis Karlsruhe
City
Karlsruhe
ZIP/Postal Code
76135
Country
Germany
Facility Name
Onkologische Gemeinschaftspraxis Kassel
City
Kassel
ZIP/Postal Code
34119
Country
Germany
Facility Name
Praxisklinik für Hämatologie und Onkologie
City
Koblenz
ZIP/Postal Code
D-56068
Country
Germany
Facility Name
Universitätsklinikum Köln, Klinik I - Innere Medizin
City
Köln
ZIP/Postal Code
D-50937
Country
Germany
Facility Name
Onkologisches Zentrum, Gemeinschaftspraxis f. Hämatologie u. Onkologie im Caritas KH
City
Lebach
ZIP/Postal Code
66822
Country
Germany
Facility Name
Klinikum Lippe GmbH, Hämatologie-Onkologie
City
Lemgo
ZIP/Postal Code
D-32657
Country
Germany
Facility Name
Schwerpunktpraxis für Hämatologie und Onkologie
City
Ludwigsburg
ZIP/Postal Code
71636
Country
Germany
Facility Name
Med. Klinik A, Klinikum der Stadt Ludwigshafen am Rhein gGmbH
City
Ludwigshafen am Rhein
ZIP/Postal Code
67063
Country
Germany
Facility Name
Internistische Schwerpunktpraxis für Hämatologie und Onkologie
City
Mainz
ZIP/Postal Code
55122
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, III. Med. Klinik
City
Mainz
ZIP/Postal Code
D-55131
Country
Germany
Facility Name
III. Medizinische Klinik Hämatologie und Internistische Onkologie
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Mannheimer Onkologie Praxis
City
Mannheim
ZIP/Postal Code
D-68161
Country
Germany
Facility Name
Philipps-Universität Marburg, Hämatologie/Onkologie/Immunologie
City
Marburg
ZIP/Postal Code
35032
Country
Germany
Facility Name
Mühlenkreiskliniken (AöR) Johannes Wesling Klinikum Minden, Hämatologie/Onkologie, Hämostaseologie und Palliativmedizin
City
Minden
ZIP/Postal Code
32429
Country
Germany
Facility Name
Krankenhaus Maria Hilf GmbH, Franziskuskrankenhaus, Med. Klinik I
City
Mönchengladbach
ZIP/Postal Code
D-41063
Country
Germany
Facility Name
Praxis für Hämatologie und internistische Onkologie
City
Oberhausen
ZIP/Postal Code
46145
Country
Germany
Facility Name
Internistisch, Onkologische Gemeinschaftspraxis Dres. Balló
City
Offenbach
ZIP/Postal Code
63065
Country
Germany
Facility Name
Onkologische Praxis Oldenburg
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
Facility Name
Krankenhaus Barmherzige Brüder, Klinik für Onkologie und Hämatologie
City
Regensburg
ZIP/Postal Code
93049
Country
Germany
Facility Name
Klinikum am Steinenberg, Ermstalklinik, Medizinische Klinik I
City
Reutlingen
ZIP/Postal Code
72764
Country
Germany
Facility Name
Diakonie-Klinikum Schwäbisch Hall gGmbH, Innere Medizin III
City
Schwäbisch Hall
ZIP/Postal Code
74523
Country
Germany
Facility Name
ZAHO-Zentrum für ambulante Hämatologie und Onkologie, Standort Siegburg
City
Siegburg
ZIP/Postal Code
D-53721
Country
Germany
Facility Name
Diakonie Klinikum Jung-Stilling-Krankenhaus, Medizinische Klinik
City
Siegen
ZIP/Postal Code
57074
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis für Onkologie und Gastroenterologie
City
Singen
ZIP/Postal Code
78224
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis Speyer
City
Speyer
ZIP/Postal Code
D-67346
Country
Germany
Facility Name
Klinikum Mutterhaus der Borromäerinnen gGmbH
City
Trier
ZIP/Postal Code
54290
Country
Germany
Facility Name
University Hospital Tübingen, Med. Klinik und Poliklinik, Abt. II
City
Tübingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Schwarzwald-Baar Klinikum, Klinik für Innere Medizin II
City
Villingen-Schwenningen
ZIP/Postal Code
78052
Country
Germany
Facility Name
Rems-Murr-Klinikum gGmbH Winnenden
City
Winnenden
ZIP/Postal Code
71364
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
31138244
Citation
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.
Results Reference
derived

Learn more about this trial

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

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