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Trial on the Effect of Isatuximab to Lenaliodomide/Bortezomib/Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma (GMMG HD7)

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ClinicalTrials.gov Identifier: NCT03617731
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Hartmut Goldschmidt, University of Heidelberg Medical Center

Brief Summary:
Trial in patients with newly diagnosed myeloma to evaluate the effect of isatuximab in induction therapy with lenalidomide/bortezomib/dexamethasone (RVd) and in lenalidomide maintenance treatment

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Lenalidomide Drug: Bortezomib Drug: Dexamethasone Drug: Isatuximab 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: Isatuximab, Lenalidomide

  1. Randomization: Patients are randomized in one of 2 study arms (IA or IB) before induction therapy. Patients randomized in arm IA will receive 3 cycles RVd (Bortezomib (Velcade®), Lenalidomide (Revlimid®, each cycle is 42 days), Dexamethasone). Patients in arm IB will additionally receive the monoclonal antibody Isatuximab in the 3 cycles RVd. After induction therapy patients undergo intensifying therapy according to GMMG standard (usually mobilization therapy followed by stem cell collection and autologous stem cell transplantation).
  2. Randomization: Before maintenance treatment patients are randomized in one of 2 study arms (IIA and IIB): Patients in arm IIA receive Lenalidomide maintenance therapy for three years, patients in arm IIB receive additional Isatuximab.

There are two primary objectives:

  1. to compare the induction regimen (IA vs IB) regarding minimal residual disease (MRD) negativity after induction (assessed by flow cytometry; sensitivity at least 1e-5)
  2. to compare the maintenance strategies (arms IIA vs IIB) regarding progression-free survival (PFS), defined as time from 2nd randomization (prior to maintenance therapy) to progression or death from any cause whichever occurs first.

The duration of the trial for each patients is expected to be 45-48 months (induction and intensification treatment: 6-9 months, 3 months rest between intensification and start of maintenance phase 36 months).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 662 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 x 2 arms, 1. randomization before induction therapy (arm IA and IB), 2. randomization before maintenance therapy (arm IIA and IIB)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial Assessing the Benefit of the Addition of Isatuximab to Lenalidomide / Bortezomib / Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma
Actual Study Start Date : October 18, 2018
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : December 2025


Arm Intervention/treatment
Active Comparator: IA
Patients in arm IA are treated with 3 cycles RVd (lenalidomide 25 mg/d p.o. d1 - 14 and d22 - 35; bortezomib 1.3 mg/m2 s.c. d1, 4, 8, 11, 22, 25, 29, 32; dexamethasone p.o. 20 mg/d d1-2, 4-5, 8-9, 11-12, 15, 22-23, 25-26, 29-30, 32-33).Treatment repeats every 42 days (d43 = cycle 2 d1). Standard intensification: For all patients, stem cells are mobilized by GMMG Standard protocols (CAD: cyclophosphamide, doxorubicin, dexamethasone) and G-CSF. At least 7.5x106 CD34+ cells/kg body weight are harvested. High dose treatment (melphalan 200mg/m², HDT) followed by autologous stem cell transplantation (ASCT) is started 4 - 6 weeks after CAD. For patients not in CR after HDT1, a second HDT is performed within 3 months.
Drug: Lenalidomide
25 mg per os on day 1-14 and d22-35 in induction cycle 1-3 (Arms IA and IB) 10 mg p.o. on day 1-28 in maintenance cycle 1-3, 15 mg p.o. on day 1-28 in maintenance cycle 4-39 (Arms IIA and IIB)
Other Name: Revlimid

Drug: Bortezomib
all arms: 1,3 mg/m^2 subcutaneous on day 1, 4, 8, 11, 22, 25, 29 32 in 3 induction cycles
Other Name: Velcade

Drug: Dexamethasone
20 mg per os on day 1,2 and 4,5 and 8,9 and 11,12 and 15 and 22,23 and 25,26 and 29,30 and 32,33 in induction cycles 1-3 (Arms IA and IB). Maintenance cycle 1 on day 1, 8, 15, 22 Dexamethasone 20 mg/d per os (Arm IIA). In Arm IIB Dexamethasone 20 mg i.v. on days of Isatuximab infusion in the first maintenance cycle (d 1, 8, 15, 22), dexamethasone will be administered intravenously as part of the premedication. If an isatuximab dose is skipped or discontinued dexamethasone should be administered orally.

Experimental: IB
Patients in arm IB are treated with 3 cycles RVd + Isatuximab (lenalidomide 25 mg/d p.o. d1 - 14 and d22 - 35; bortezomib 1.3 mg/m2 s.c. d1, 4, 8, 11, 22, 25, 29, 32;dexamethasone p.o. 20 mg/d d1-2, 4-5, 8-9, 11-12, 15, 22-23, 25-26, 29-30, 32-33).Isatuximab (10 mg/kg i.v. C1: d 1, 8, 15, 22, 29; C2-3: d 1, 15, 29).Treatment repeats every 42 days (d43 = cycle 2 d1). Standard intensification: For all patients, stem cells are mobilized by GMMG Standard protocols (CAD: cyclophosphamide, doxorubicin, dexamethasone) and G-CSF. At least 7.5x106 CD34+ cells/kg body weight are harvested. High dose treatment (melphalan 200mg/m², HDT) followed by autologous stem cell transplantation (ASCT) is started 4 - 6 weeks after CAD. For patients not in CR after HDT1, a second HDT is performed within 3 months.
Drug: Lenalidomide
25 mg per os on day 1-14 and d22-35 in induction cycle 1-3 (Arms IA and IB) 10 mg p.o. on day 1-28 in maintenance cycle 1-3, 15 mg p.o. on day 1-28 in maintenance cycle 4-39 (Arms IIA and IIB)
Other Name: Revlimid

Drug: Bortezomib
all arms: 1,3 mg/m^2 subcutaneous on day 1, 4, 8, 11, 22, 25, 29 32 in 3 induction cycles
Other Name: Velcade

Drug: Dexamethasone
20 mg per os on day 1,2 and 4,5 and 8,9 and 11,12 and 15 and 22,23 and 25,26 and 29,30 and 32,33 in induction cycles 1-3 (Arms IA and IB). Maintenance cycle 1 on day 1, 8, 15, 22 Dexamethasone 20 mg/d per os (Arm IIA). In Arm IIB Dexamethasone 20 mg i.v. on days of Isatuximab infusion in the first maintenance cycle (d 1, 8, 15, 22), dexamethasone will be administered intravenously as part of the premedication. If an isatuximab dose is skipped or discontinued dexamethasone should be administered orally.

Drug: Isatuximab
10 mg/kg in the vein( i.v) on day 1,8,15, 22, 29 in induction cycle 1 on day 1, 15 and 29 in induction cycle 2 and 3 (Arm IB). 10 mg/kg i.v. on day 1,8, 15 and 22 in maintenance cycle 1, 10 mg/kg i.v. on day 1 and 15 in maintenance cycle 2 and 3, 10 mg/kg i.v. on day 1 in maintenance cycle 4 - 39 (Arm IIB)

Active Comparator: IIA
maintenance treatment with Lenalidomide 10mg/d (increased to 15mg/d after 3 months) repeated every 28d. Maintenance treatment is planned for up to 36 months or until progression if progression occurs first.
Drug: Lenalidomide
25 mg per os on day 1-14 and d22-35 in induction cycle 1-3 (Arms IA and IB) 10 mg p.o. on day 1-28 in maintenance cycle 1-3, 15 mg p.o. on day 1-28 in maintenance cycle 4-39 (Arms IIA and IIB)
Other Name: Revlimid

Experimental: IIB
maintenance treatment with Lenalidomide 10mg/d (increased to 15mg/d after 3 months) + Isatuximab (10 mg/kg; C1: d1, 8, 15, 22; C2-C3: d1 + 15; C4-39:d1, repeated every 28d). Within the trial, maintenance treatment is planned for up to 36 months or until progression if progression occurs first.
Drug: Lenalidomide
25 mg per os on day 1-14 and d22-35 in induction cycle 1-3 (Arms IA and IB) 10 mg p.o. on day 1-28 in maintenance cycle 1-3, 15 mg p.o. on day 1-28 in maintenance cycle 4-39 (Arms IIA and IIB)
Other Name: Revlimid

Drug: Isatuximab
10 mg/kg in the vein( i.v) on day 1,8,15, 22, 29 in induction cycle 1 on day 1, 15 and 29 in induction cycle 2 and 3 (Arm IB). 10 mg/kg i.v. on day 1,8, 15 and 22 in maintenance cycle 1, 10 mg/kg i.v. on day 1 and 15 in maintenance cycle 2 and 3, 10 mg/kg i.v. on day 1 in maintenance cycle 4 - 39 (Arm IIB)




Primary Outcome Measures :
  1. MRD negativity after induction Treatment (comparison of arms IA and IB) [ Time Frame: 18 weeks after start of study treatment ]
    Detection of minimal residual disease by flow cytometry (sensitivity at least 1e-5)

  2. Progression Free Survival (PFS) after second randomization (arms IIA and IIB) [ Time Frame: time from 2. randomization to progression or death from any cause whichever comes first, censored after three years of maintenance therapy ]
    Response Evaluation by IMWG criteria


Secondary Outcome Measures :
  1. to compare the four treatment arms (IA-IIA, IA-IIB, IB-IIA, IB-IIB) regarding Progression free survival (PFS) [ Time Frame: time from 1. randomization (study inclusion) to progression or death whichever comes first (assessed up to 79 months) ]
    Response evaluation by IMWG criteria

  2. to compare all 4 treatment arms (IA-IIA, IA-IIB, IB-IIA, IB-IIB) regarding overall survival (OS) from time of 1.randomization [ Time Frame: time from randomisation to time of death from any cause (assessed up to 79 months) ]
    survival status

  3. Overall survival from second randomization [ Time Frame: time from 2. randomization to time of death from any cause (assessed up to 75 months) ]
    survival status

  4. Complete Response (CR) rates after induction therapy [ Time Frame: After induction treatment (18 weeks after start of treatment) ]
    Response Evaluation by IMWG criteria

  5. Complete Response (CR) after high dose therapy [ Time Frame: After high dose therapy (9 or 12 months after start of therapy) ]
    Response Evaluation by IMWG criteria

  6. Complete Response (CR) during/after maintenance therapy [ Time Frame: During/after maintenance therapy (6 months after start of therapy up to 36 months of maintenance therapy) ]
    Response Evaluation by IMWG criteria

  7. MRD negativity after high dose therapy [ Time Frame: After high dose therapy (9 or 12 months after start of therapy) ]
    Detection of minimal residual disease by flow cytometry (sensitivity at least 1e-5)

  8. MRD negativity during and after maintenance therapy [ Time Frame: up to 36 months after start of maintenance therapy ]
    Detection of minimal residual disease by flow cytometry (sensitivity at least 1e-5)

  9. Best response to treatment during the trial [ Time Frame: response assessment after 3 months, 4,5 months, 5,5 months, 9 months (if applicable: 3 months later after 2. high dose therapy) subsequently every 3 months during maintenance treatment, up to 48 months after start of study treatment ]
    Response evaluation by IMWG criteria

  10. PFS 2 (PFS after next line of therapy) from 2. randomization [ Time Frame: time from 2. randomization to time of overall end of trial (up to 75 months) ]
    Response evaluation by IMWG criteria

  11. Toxicity during induction and maintenance with respect to adverse events of CTC grade >3 (and specific adverse events of CTC grade > 2 as defined in the protocol and serious adverse events [ Time Frame: : from first administration of study drug until 30 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 v5.0

  12. Quality of Life Assessment [ Time Frame: assessed at baseline, after ca. 4.5 months, 9 months, (additionally after 12 months,if a second high dose therapy is administered) after 12 months of maintenance and at end of study (up to 50 months) ]
    EORTC (European Organization of Research and Treatment of Cancer) -QLQC30 Questionnaire to assess the quality of life of cancer patients. Impairment of daily life is asked in 4 scales from "not at all" (best) to "very much" (worst scale), EORTC-QLQMY20 questionnaire to assess health-related quality of life in patients with multiple myeloma with 4 scales from "not at all (best scale) to "very much" (worst scale); EQ(EuroQol Group)-5D-5L Health questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Additionally a visual analogue scale from 100 (best) to 0 (worst scale) is used to assess the quality of health questionnaires.

  13. Pharmakokinetic analyses of Isatuximab in induction treatment of patients in Arm IB (selected sites only) [ Time Frame: Up to 18 weeks in induction treatment (C1: D1, before infusion, at end of infusion, 1 h after infusion, C1 D8,15,22,29 before infusion; C2 and 3:D1 before infusion ]
    Determination of serum concentration of isatuximab at different timepoints before, during and after isatuximab infusion

  14. Pharmakokinetic analyses of Isatuximab in maintenance treatment of patients in Arm IIB (selected sites only) [ Time Frame: Up to 9 months (C1: D1, before infusion, at end of infusion, 1 h after infusion, C1 D8,15,22 before infusion, C2 -9, D1: before infusion ]
    Determination of serum concentration of isatuximab at different timepoints



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Confirmed diagnosis of untreated multiple myeloma requiring systemic therapy (diagnostic criteria (IMWG updated criteria (2014)1) see appendix IA. For some patients systemic therapy may be required though these diagnostic criteria are not fulfilled. In this case the GMMG study office has to be consulted prior to inclusion.)
  2. Patient is eligible for high dose therapy and autologous stem cell transplantation.
  3. Measurable disease, defined as any quantifiable monoclonal protein value, defined by at least one of the following three measurements:2

    • 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
  4. Age 18 - 70 years inclusive
  5. WHO performance status 0-2
  6. Negative pregnancy test at inclusion (females of childbearing potential)
  7. All patients must agree on the requirements regarding the lenalidomide pregnancy prevention plan described in section 6. For all men and females of childbearing potential: patients must be willing and capable to use adequate contraception during the complete therapy.
  8. 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
  9. Ability of patient to understand character and individual consequences of the clinical trial
  10. Provide written informed consent (must be available before enrolment in the trial)

Exclusion Criteria

  1. Patient has known hypersensitivity (or contraindication) to dexamethasone, sucrose histidine (as base and hydrochloride salt), boron, mannitol, and polysorbate 80 or any of the components of study therapy that are not amenable to premedication with steroids or H2 blockers that would prohibit further treatment with these agents.
  2. Systemic AL amyloidosis (except for AL amyloidosis of the skin or the bone marrow)
  3. Plasma cell leukemia
  4. Previous chemotherapy or radiotherapy during the past 5 years except local radiotherapy in case of local myeloma progression. (Note: patients may have received a cumulative dose of up to 160 mg of dexamethasone or equivalent as emergency therapy.) Previous therapy due to smouldering myeloma may be acceptable. In this case the GMMG study office has to be consulted prior to inclusion
  5. Severe cardiac dysfunction (NYHA classification III-IV), ejection fraction < 40%
  6. Significant hepatic dysfunction (ASAT and/or ALAT ≥ 3 times normal level and/or serum bilirubin ≥ 1.5 times normal level if not due to hereditary abnormalities as Gilbert's disease), unless related to myeloma.
  7. Patients with active or history of hepatitis B or C
  8. HIV positivity
  9. Patients with active, uncontrolled infections
  10. Patients with severe renal insufficiency (Creatinine Clearance < 30ml/min)
  11. 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 5.0)
  12. Patients with a history of active malignancy during the past 5 years with the exception of following malignancies after curative therapy: basal cell carcinoma of the skin, squamous cell skin carcinoma, stage 0 cervical carcinoma or any in situ malignancy
  13. Patients with acute diffuse infiltrative pulmonary and/or pericardial disease
  14. Autoimmune hemolytic anemia with positive Coombs test or immune thrombocytopenia
  15. Platelet count < 75 x 109/l
  16. Haemoglobin < 8.0 g/dl, unless related to myeloma
  17. Absolute neutrophil count (ANC) < 1.0 x 109/l (the use of colony stimulating factors within 14 days before the test is not allowed)
  18. Corrected serum calcium > 14 mg/dl (> 3.5 mmol/l)
  19. Unable or unwilling to undergo thromboprophylaxis
  20. Pregnancy and lactation
  21. 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.
  22. Prisoners or subjects who are legally institutionalized, or those unwilling or unable to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617731


Contacts
Contact: GMMG Study Office 0049-6221-568198 studiensekretariat.gmmg@med.uni-heidelberg.de
Contact: Uta Bertsch, Dr. 0049-6221-568015 uta.bertsch@med.uni-heidelberg.de

Locations
Germany
HELIOS Klinikum, Klinik für Hämatologie, Onkologie und Immunologie Not yet recruiting
Berlin, Germany, 13125
Contact: Stephan Fuhrmann, Dr.    030 ext 940112151    stephan.fuhrmann@helios-kliniken.de   
Contact: Judith Niederland, Dr.       judith.niederland@helios-kliniken.de   
Klinikum Bielefeld, Klinik für Hämatologie, Onkologie und Palliativmedizin Not yet recruiting
Bielefeld, Germany, D-33604
Contact: Martin Görner, Dr. med.    0521-581-3601    martin.goerner@klinikumbielefeld.de   
Contact: Ulrich Krümpelmann, Dr.       ulrich.kruempelmann@klinikumbielefeld.de   
Medizinische Universitätsklinik, Knappschaftskrankenhaus Not yet recruiting
Bochum, Germany, D-44892
Contact: Roland Schroers, Prof. Dr. med.    0234-2993447    roland.schroers@rub.de   
Contact: Lars Petersen, Dr.         
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III, Schwerpunkt Onkologie, Hämatologie und Rheumatologie Not yet recruiting
Bonn, Germany, 53105
Contact: Annkristin Heine, Dr.    0228 ext 28717232    annkristin.heine@ukb.uni-bonn.de;   
Contact: Jai-Juen Shiue, Dr.         
Klinikum Chemnitz GmbH, Innere Medizin III Not yet recruiting
Chemnitz, Germany, D-09116
Contact: Mathias Hänel, PD Dr. med.    0371-333-43045    m.haenel@skc.de   
Contact: Anke Morgner, Dr.         
Onkologisches Studienzentrum Darmstadt Not yet recruiting
Darmstadt, Germany, 64283
Contact: Gerrit Dingeldein         
Contact: Georgi Kojouharoff, Dr.    06151-130480      
Klinikum Darmstadt, Med. Klinik V, Hämatologie/Onkologie Not yet recruiting
Darmstadt, Germany, D-64283
Contact: Helga Bernhard, Prof. Dr.    06151-107-6651    helga.bernhard@mail.klinikum-darmstadt.de   
Contact: Tu-Anh Dang, Dr.       tu-anh.dang@mail.klinikum-darmstadt.de   
HELIOS St. Johannes Klinik, Akademisches Krankenhaus der Heinrich-Heine-Universität Düsseldorf Not yet recruiting
Duisburg, Germany, 47166
Contact: Michael n.a. Heinsch, Dr.    0203 ext 5462442    michael.heinsch@helios-kliniken.de   
Universitätsklinikum Düsseldorf, Klinik für Hämatologie,Onkologie und Klin. Immunologie Not yet recruiting
Düsseldorf, Germany, D-40225
Contact: Roland Fenk, Prof. Dr.    0211-811-7760    fenk@med.uni-duesseldorf.de   
Contact: Amelie Boquoi, Dr.         
Universitätsklinik Erlangen Not yet recruiting
Erlangen, Germany, 91054
Contact: Barbara Ferstl, Dr.    09131 ext 8543104    Barbara.Ferstl@uk-erlangen.de   
Contact: Andreas Mackensen, Prof.       Andreas.Mackensen@uk-erlangen.de   
Universitätsklinikum Essen, Klinik für Hämatologie Not yet recruiting
Essen, Germany, D-45147
Contact: Jan Dürig, Prof. Dr.    0201-72384621    jan.duerig@uni-essen.de   
Contact: Karl Richard Maria Noppeney, Dr.    0201-72384215      
Ev. Krankenhaus Essen-Werden gGmbH, Zentrum für Innere Medizin, Klinik für Hämatologie, Onkologie und Stammzelltransplantation Not yet recruiting
Essen, Germany, D-45239
Contact: Mohammed Wattad, Dr.    0201-4089 2246    m.wattad@kliniken-essen-sued.de   
Contact: Peter Reimer, Prof. Dr.    0201-4089-0    p.reimer@kliniken-essen-sued.de   
Universitätsklinikum Frankfurt, Goethe-Universität Medizinische Klinik II Not yet recruiting
Frankfurt am Main, Germany, 60590
Contact: Wilde Birgit    069-6301 ext 86708    Birgit.Wilde@kgu.de   
Kath. Krankenhaus Hagen gGmbH, Abt. Hämatologie/Onkologie Not yet recruiting
Hagen, Germany, D-58095
Contact: Hans-Walter Lindemann, Dr.    02331-129-0    w.lindemann@kkh-hagen.de   
Contact: Cordula Maria Elisabeth Maciejewski       maciejewskic@kkh-hagen.de   
Asklepios Klinik Hamburg Altona, II. Med. Klinik Not yet recruiting
Hamburg, Germany, D-22763
Contact: Hans Salwender, Dr.    040-181881-1212    h.salwender@asklepios.com   
KRH Klinikum Siloah, Klinik für Hämatologie und Onkologie Not yet recruiting
Hannover, Germany, 30459
Contact: Martin Müller, PD Dr.         
Contact: Kim Marienhagen         
University Hospital Heidelberg, Med. Klinik V Recruiting
Heidelberg, Germany, D-69120
Contact: GMMG Study Office       studiensekretariat.gmmg@med.uni-heidelberg.de   
Principal Investigator: Hartmut Goldschmidt, Prof. Dr.         
SLK Kliniken Heilbronn, Med. Klinik III Not yet recruiting
Heilbronn, Germany, D-74078
Contact: Uwe Martens, Prof. Dr.       uwe.martens@slk-kliniken.de   
Contact: Markus Lindauer, Dr.         
Praxisklinik für Hämatologie und Onkologie Not yet recruiting
Koblenz, Germany, D-56068
Contact: Jörg Thomalla, Dr. med.    0261-30493-0    thomalla@onkologie-koblenz.de   
Contact: Rudolf Weide, Prof. Dr.         
Med. Klinik A, Klinikum der Stadt Ludwigshafen am Rhein gGmbH Not yet recruiting
Ludwigshafen am Rhein, Germany, 67063
Contact: Martin Hoffmann, Dr.    0621 ext 50340702    HoffmanM@klilu.de   
Contact: Michael Uppenkamp, Prof. Dr.    0621 ext 50340702      
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, III. Med. Klinik Not yet recruiting
Mainz, Germany, D-55131
Contact: Markus Munder, PD. Dr. med.    06131-17-5948    markus.munder@unimedizin-mainz.de   
Contact: Georg Heß, PD Dr.         
III. Medizinische Klinik Hämatologie und Internistische Onkologie Not yet recruiting
Mannheim, Germany, 68167
Contact: Stefan Klein, PD Dr.    0621-383-4114    stefan.klein@umm.de   
Mannheimer Onkologie Praxis Not yet recruiting
Mannheim, Germany, D-68161
Contact: Manfred Hensel, Prof. Dr. med.       hensel@mannheimer-onkologie-praxis.de   
Contact: Dieter Schuster, Dr. med.         
Philipps-Universität Marburg, Hämatologie/Onkologie/Immunologie Not yet recruiting
Marburg, Germany, 35032
Contact: Andreas Neubauer, Prof. Dr.       neubauer@med.uni-marburg.de   
Contact: Ellen Wollmer, Dr.       wollmer@med.uni-marburg.de   
Mühlenkreiskliniken (AöR) Johannes Wesling Klinikum Minden, Hämatologie/Onkologie, Hämostaseologie und Palliativmedizin Not yet recruiting
Minden, Germany, 32429
Contact: Hans-Joachim Tischler, Dr.    0571 ext 7904202    hans-joachim.tischler@muehlenkreiskliniken.de   
Contact: Kai Wille, Dr.    0571 ext 79051193    kai.wille@muehlenkreiskliniken.de   
Krankenhaus Maria Hilf GmbH, Franziskuskrankenhaus, Med. Klinik I Not yet recruiting
Mönchengladbach, Germany, D-41063
Contact: Ullrich Graeven, PD Dr.    02161-892-2201    Ullrich.Graeven@mariahilf.de   
Contact: Heidi Herfert    02161-892-2372    heidi.herfert@mariahilf.de   
Krankenhaus Barmherzige Brüder, Klinik für Onkologie und Hämatologie Not yet recruiting
Regensburg, Germany, 93049
Contact: Bernhard Heilmeier, Dr.    0941 ext 36992152    bernhard.heilmeier@barmherzige-regensburg.de   
Contact: Anke Schlenska-Lange, Dr.       anke.schlenska-lange@barmherzige-regensburg.de;   
Diakonie-Klinikum Schwäbisch Hall gGmbH, Innere Medizin III Not yet recruiting
Schwäbisch Hall, Germany, 74523
Contact: Sabine Kraft    0791-753-4018 ext 4486    sabine.kraft@dasdiak.de   
Contact: Samiha Priwitzer       Samiha.priwitzer@dasdiak.de   
ZAHO-Zentrum für ambulante Hämatologie und Onkologie, Standort Siegburg Not yet recruiting
Siegburg, Germany, D-53721
Contact: Stefan Fronhoffs, Dr.       sfronhoffs@zaho-rheinland.de   
Contact: Bettina Bürgel    02241-5954-23    studienbuero@zaho-rheinland.de   
Onkologische Schwerpunktpraxis Speyer Not yet recruiting
Speyer, Germany, D-67346
Contact: Joachim Behringer, Dr. med.       j.behringer@onkologie-speyer.de   
Contact: Lars Scheuer, Dr.    06232-604460    onkologie-speyer@t-online.de   
University Hospital Tübingen, Med. Klinik und Poliklinik, Abt. II Not yet recruiting
Tübingen, Germany, D-72076
Contact: Katja Weisel, PD Dr.    07071-29-84321    katja.weisel@med.uni-tuebingen.de   
Contact: Britta Besemer, Dr.       britta.besemer@med.uni-tuebingen.de   
Sponsors and Collaborators
University of Heidelberg Medical Center
Investigators
Principal Investigator: Hartmut Goldschmidt, Prof. Dr. Med. Klinik V, University Hospital Heidelberg

Responsible Party: Prof. Dr. Hartmut Goldschmidt, Head of Division of Multiple Myeloma, University of Heidelberg Medical Center
ClinicalTrials.gov Identifier: NCT03617731     History of Changes
Other Study ID Numbers: GMMG HD7
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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 acetate
Dexamethasone
Lenalidomide
Thalidomide
Bortezomib
BB 1101
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