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

Sponsor
University of Heidelberg Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02495922
Collaborator
(none)
564
Enrollment
68
Locations
4
Arms
72.8
Duration (Months)
8.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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).

Study Design

Study Type:
Interventional
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 :
Jun 1, 2015
Actual Primary Completion Date :
Jun 24, 2021
Actual Study Completion Date :
Jun 24, 2021

Arms and Interventions

ArmIntervention/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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 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 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 [approx. after 3 months (after induction therapy)]

      response evaluation

    3. complete response rates after consolidation [approx. after 9 months (after consolidation therapy)]

      response evaluation

    4. Progression Free Survival after end of trial [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 [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 [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 [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 [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    SiteCityStateCountryPostal Code
    1Studienzentrum AschaffenburgAschaffenburgGermany63739
    2MVZ Onkologie gGmbH der Klinikum Mittelbaden gGmbHBaden-BadenGermany76532
    3HELIOS Klinikum, Klinik für Hämatologie, Onkologie und ImmunologieBerlinGermany13125
    4Onkologisches MVZ Berlin TegelBerlinGermany13507
    5Charité Campus Benjamin Franklin, III. Med. Abt. (Hämatologie/Onkologie)BerlinGermanyD-12200
    6Klinikum Bielefeld, Klinik für Hämatologie, Onkologie und PalliativmedizinBielefeldGermanyD-33604
    7Studiengesellschaft Onkologie Bielefeld GbRBielefeldGermanyD-33604
    8Hämatologisch-onkologische SchwerpunktpraxisBochumGermany44787
    9Medizinische Universitätsklinik, KnappschaftskrankenhausBochumGermanyD-44892
    10Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III, Schwerpunkt Onkologie, Hämatologie und RheumatologieBonnGermany53105
    11ZAHO, Zentrum für ambulante Hämatologie und OnkologieBonnGermany53113
    12Schwerpunktpraxis für Onkologie/HämatologieBottropGermany46236
    13Klinikum Chemnitz GmbH, Innere Medizin IIIChemnitzGermanyD-09116
    14Onkologisches Studienzentrum DarmstadtDarmstadtGermany64283
    15Klinikum Darmstadt, Med. Klinik V, Hämatologie/OnkologieDarmstadtGermanyD-64283
    16HELIOS St. Johannes Klinik, Akademisches Krankenhaus der Heinrich-Heine-Universität DüsseldorfDuisburgGermany47166
    17MVZ Düsseldorf GmbHDusseldorfGermany40235
    18Sana Kliniken Düsseldorf GmbHDüsseldorfGermany40593
    19Universitätsklinikum Düsseldorf, Klinik für Hämatologie,Onkologie und Klin. ImmunologieDüsseldorfGermanyD-40225
    20Universitätsklinik ErlangenErlangenGermany91054
    21St.-Antonius-Hospital Klinik f. Hämatologie und OnkologieEschweilerGermany52249
    22Universitätsklinikum Essen, Klinik für HämatologieEssenGermanyD-45147
    23Ev. Krankenhaus Essen-Werden gGmbH, Zentrum für Innere Medizin, Klinik für Hämatologie, Onkologie und StammzelltransplantationEssenGermanyD-45239
    24Centrum für Hämatologie und Onkologie BethanienFrankfurt am MainGermany60389
    25Universitätsklinikum Frankfurt, Goethe-Universität Medizinische Klinik IIFrankfurt am MainGermany60590
    26Agaplesion Markus KrankenhausFrankfurt/MainGermany60431
    27Praxis und Tagesklinik FriedrichshafenFriedrichshafenGermany88045
    28Gemeinschaftspraxis Schmitt/EulenbuchGerlingenGermany70839
    29Justus-Liebig-Universität, Medizinische Klinik IVGießenGermany35385
    30Kath. Krankenhaus Hagen gGmbH, Abt. Hämatologie/OnkologieHagenGermanyD-58095
    31Universitätsklinikum Hamburg-Eppendorf, II - Med. Klinik und PoliklinikHamburgGermanyD-20246
    32Asklepios Klinik Hamburg Altona, II. Med. KlinikHamburgGermanyD-22763
    33Evangelisches Krankhaus Hamm gGmbHHammGermany59063
    34Onkologische SchwerpunktpraxisHeidelbergGermany69115
    35University Hospital Heidelberg, Med. Klinik VHeidelbergGermanyD-69120
    36Onkologische SchwerpunktpraxisHeilbronnGermany74072
    37SLK Kliniken Heilbronn, Med. Klinik IIIHeilbronnGermanyD-74078
    38Universitätsklinikum des Saarlandes, Innere Medizin IHomburgGermany66421
    39Westpfalz-Klinikum GmbHKaiserslauternGermany67655
    40Onkologische Schwerpunktpraxis KarlsruheKarlsruheGermany76135
    41Onkologische Gemeinschaftspraxis KasselKasselGermany34119
    42Praxisklinik für Hämatologie und OnkologieKoblenzGermanyD-56068
    43Universitätsklinikum Köln, Klinik I - Innere MedizinKölnGermanyD-50937
    44Onkologisches Zentrum, Gemeinschaftspraxis f. Hämatologie u. Onkologie im Caritas KHLebachGermany66822
    45Klinikum Lippe GmbH, Hämatologie-OnkologieLemgoGermanyD-32657
    46Schwerpunktpraxis für Hämatologie und OnkologieLudwigsburgGermany71636
    47Med. Klinik A, Klinikum der Stadt Ludwigshafen am Rhein gGmbHLudwigshafen am RheinGermany67063
    48Internistische Schwerpunktpraxis für Hämatologie und OnkologieMainzGermany55122
    49Universitätsmedizin der Johannes Gutenberg-Universität Mainz, III. Med. KlinikMainzGermanyD-55131
    50III. Medizinische Klinik Hämatologie und Internistische OnkologieMannheimGermany68167
    51Mannheimer Onkologie PraxisMannheimGermanyD-68161
    52Philipps-Universität Marburg, Hämatologie/Onkologie/ImmunologieMarburgGermany35032
    53Mühlenkreiskliniken (AöR) Johannes Wesling Klinikum Minden, Hämatologie/Onkologie, Hämostaseologie und PalliativmedizinMindenGermany32429
    54Krankenhaus Maria Hilf GmbH, Franziskuskrankenhaus, Med. Klinik IMönchengladbachGermanyD-41063
    55Praxis für Hämatologie und internistische OnkologieOberhausenGermany46145
    56Internistisch, Onkologische Gemeinschaftspraxis Dres. BallóOffenbachGermany63065
    57Onkologische Praxis OldenburgOldenburgGermany26121
    58Krankenhaus Barmherzige Brüder, Klinik für Onkologie und HämatologieRegensburgGermany93049
    59Klinikum am Steinenberg, Ermstalklinik, Medizinische Klinik IReutlingenGermany72764
    60Diakonie-Klinikum Schwäbisch Hall gGmbH, Innere Medizin IIISchwäbisch HallGermany74523
    61ZAHO-Zentrum für ambulante Hämatologie und Onkologie, Standort SiegburgSiegburgGermanyD-53721
    62Diakonie Klinikum Jung-Stilling-Krankenhaus, Medizinische KlinikSiegenGermany57074
    63Onkologische Schwerpunktpraxis für Onkologie und GastroenterologieSingenGermany78224
    64Onkologische Schwerpunktpraxis SpeyerSpeyerGermanyD-67346
    65Klinikum Mutterhaus der Borromäerinnen gGmbHTrierGermany54290
    66University Hospital Tübingen, Med. Klinik und Poliklinik, Abt. IITübingenGermanyD-72076
    67Schwarzwald-Baar Klinikum, Klinik für Innere Medizin IIVillingen-SchwenningenGermany78052
    68Rems-Murr-Klinikum gGmbH WinnendenWinnendenGermany71364

    Sponsors and Collaborators

    • University of Heidelberg Medical Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Jul 13, 2015
    Last Update Posted:
    Sep 10, 2021
    Last Verified:
    Sep 1, 2021

    Study Results

    No Results Posted as of Sep 10, 2021