AzTrials
AzTrials

Multiple MyelomaPhase 3GMMG-HD6NCT02495922

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

A Phase 3 study testing elotuzumab, Lenalidomide and Bortezomib in people with Multiple Myeloma, run by University of Heidelberg Medical Center at 68 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Multiple Myeloma
What is being tested?
elotuzumab, Lenalidomide and Bortezomib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
564 participants
Where
68 sitesGermany
Study dates
Jun 2015to 24 Jun 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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)

Who cannot join

  • 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.
Show all 20Show fewer
  • 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.

Trial locations and contacts

68 sites in 1 country.

68 sites in 1 country

Germany68 sites

  • Studienzentrum Aschaffenburg

    Aschaffenburg, 63739

  • MVZ Onkologie gGmbH der Klinikum Mittelbaden gGmbH

    Baden-Baden, 76532

  • HELIOS Klinikum, Klinik für Hämatologie, Onkologie und Immunologie

    Berlin, 13125

  • Onkologisches MVZ Berlin Tegel

    Berlin, 13507

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

    Berlin, D-12200

  • Klinikum Bielefeld, Klinik für Hämatologie, Onkologie und Palliativmedizin

    Bielefeld, D-33604

  • Studiengesellschaft Onkologie Bielefeld GbR

    Bielefeld, D-33604

  • Hämatologisch-onkologische Schwerpunktpraxis

    Bochum, 44787

  • Medizinische Universitätsklinik, Knappschaftskrankenhaus

    Bochum, D-44892

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

    Bonn, 53105

  • ZAHO, Zentrum für ambulante Hämatologie und Onkologie

    Bonn, 53113

  • Schwerpunktpraxis für Onkologie/Hämatologie

    Bottrop, 46236

  • Klinikum Chemnitz GmbH, Innere Medizin III

    Chemnitz, D-09116

  • Universitätsklinikum Köln, Klinik I - Innere Medizin

    Cologne, D-50937

  • Onkologisches Studienzentrum Darmstadt

    Darmstadt, 64283

  • Klinikum Darmstadt, Med. Klinik V, Hämatologie/Onkologie

    Darmstadt, D-64283

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

    Duisburg, 47166

  • MVZ Düsseldorf GmbH

    Düsseldorf, 40235

  • Sana Kliniken Düsseldorf GmbH

    Düsseldorf, 40593

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

    Düsseldorf, D-40225

  • Universitätsklinik Erlangen

    Erlangen, 91054

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

    Eschweiler, 52249

  • Universitätsklinikum Essen, Klinik für Hämatologie

    Essen, D-45147

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

    Essen, D-45239

  • Centrum für Hämatologie und Onkologie Bethanien

    Frankfurt am Main, 60389

  • Agaplesion Markus Krankenhaus

    Frankfurt am Main, 60431

  • Universitätsklinikum Frankfurt, Goethe-Universität Medizinische Klinik II

    Frankfurt am Main, 60590

  • Praxis und Tagesklinik Friedrichshafen

    Friedrichshafen, 88045

  • Gemeinschaftspraxis Schmitt/Eulenbuch

    Gerlingen, 70839

  • Justus-Liebig-Universität, Medizinische Klinik IV

    Giessen, 35385

  • Kath. Krankenhaus Hagen gGmbH, Abt. Hämatologie/Onkologie

    Hagen, D-58095

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

    Hamburg, D-20246

  • Asklepios Klinik Hamburg Altona, II. Med. Klinik

    Hamburg, D-22763

  • Evangelisches Krankhaus Hamm gGmbH

    Hamm, 59063

  • Onkologische Schwerpunktpraxis

    Heidelberg, 69115

  • University Hospital Heidelberg, Med. Klinik V

    Heidelberg, D-69120

  • Onkologische Schwerpunktpraxis

    Heilbronn, 74072

  • SLK Kliniken Heilbronn, Med. Klinik III

    Heilbronn, D-74078

  • Universitätsklinikum des Saarlandes, Innere Medizin I

    Homburg, 66421

  • Westpfalz-Klinikum GmbH

    Kaiserslautern, 67655

  • Onkologische Schwerpunktpraxis Karlsruhe

    Karlsruhe, 76135

  • Onkologische Gemeinschaftspraxis Kassel

    Kassel, 34119

  • Praxisklinik für Hämatologie und Onkologie

    Koblenz, D-56068

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

    Lebach, 66822

  • Klinikum Lippe GmbH, Hämatologie-Onkologie

    Lemgo, D-32657

  • Schwerpunktpraxis für Hämatologie und Onkologie

    Ludwigsburg, 71636

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

    Ludwigshafen am Rhein, 67063

  • Internistische Schwerpunktpraxis für Hämatologie und Onkologie

    Mainz, 55122

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

    Mainz, D-55131

  • III. Medizinische Klinik Hämatologie und Internistische Onkologie

    Mannheim, 68167

  • Mannheimer Onkologie Praxis

    Mannheim, D-68161

  • Philipps-Universität Marburg, Hämatologie/Onkologie/Immunologie

    Marburg, 35032

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

    Minden, 32429

  • Krankenhaus Maria Hilf GmbH, Franziskuskrankenhaus, Med. Klinik I

    Mönchengladbach, D-41063

  • Praxis für Hämatologie und internistische Onkologie

    Oberhausen, 46145

  • Internistisch, Onkologische Gemeinschaftspraxis Dres. Balló

    Offenbach, 63065

  • Onkologische Praxis Oldenburg

    Oldenburg, 26121

  • Krankenhaus Barmherzige Brüder, Klinik für Onkologie und Hämatologie

    Regensburg, 93049

  • Klinikum am Steinenberg, Ermstalklinik, Medizinische Klinik I

    Reutlingen, 72764

  • Diakonie-Klinikum Schwäbisch Hall gGmbH, Innere Medizin III

    Schwäbisch Hall, 74523

  • ZAHO-Zentrum für ambulante Hämatologie und Onkologie, Standort Siegburg

    Siegburg, D-53721

  • Diakonie Klinikum Jung-Stilling-Krankenhaus, Medizinische Klinik

    Siegen, 57074

  • Onkologische Schwerpunktpraxis für Onkologie und Gastroenterologie

    Singen, 78224

  • Onkologische Schwerpunktpraxis Speyer

    Speyer, D-67346

  • Klinikum Mutterhaus der Borromäerinnen gGmbH

    Trier, 54290

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

    Tübingen, D-72076

  • Schwarzwald-Baar Klinikum, Klinik für Innere Medizin II

    Villingen-Schwenningen, 78052

  • Rems-Murr-Klinikum gGmbH Winnenden

    Winnenden, 71364

Other trials in Germany

About this study

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

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

Read the 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).

Being tested
elotuzumab, Lenalidomide, Bortezomib, Dexamethasone
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • elotuzumabDrug

    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)

  • LenalidomideDrug

    Also called Revlimid

    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)

  • BortezomibDrug

    Also called Velcade

    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

  • DexamethasoneDrug

    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).

Study groups in NCT02495922
Study groupRoleWhat they receive
A1Active comparatorInduction 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).
Receives: Drug: Lenalidomide; Drug: Bortezomib; Drug: Dexamethasone
A2ExperimentalInduction 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).
Receives: Drug: elotuzumab; Drug: Lenalidomide; Drug: Bortezomib; Drug: Dexamethasone
B1ExperimentalInduction 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).
Receives: Drug: elotuzumab; Drug: Lenalidomide; Drug: Bortezomib; Drug: Dexamethasone
B2ExperimentalInduction 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).
Receives: Drug: elotuzumab; Drug: Lenalidomide; Drug: Bortezomib; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the best of four treatment strategies regarding Progression Free Survival (PFS)

    response evaluation

    Measured: 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 outcomes (9)

  1. overall survival

    survival status

    Measured: 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)

  2. complete response rates after induction

    response evaluation

    Measured: approx. after 3 months (after induction therapy)

  3. complete response rates after consolidation

    response evaluation

    Measured: approx. after 9 months (after consolidation therapy)

  4. Progression Free Survival after end of trial

    response evaluation

    Measured: 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)

  5. best response to treatment during the study

    response evaluation

    Measured: 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.

  6. time to progression, censored at end of the trial

    Response evaluation

    Measured: From date of randomization until the date of first documented progression, assessed up to 80 months

  7. duration of response, censored at end of the trial

    response evaluation

    Measured: assessed up to 80 months

  8. 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

    Measured: 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

  9. Quality of Life assessment

    Questionnaires EORTC-QLQC30 and EORTC-QLQMY20

    Measured: assessed at baseline, after ca. 3 months, 7 months, 9 months, subsequently every 6 months, up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2015 (estimated)
  2. Study startJun 2015
  3. Primary completion24 Jun 2021
  4. Study completion24 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
564 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02495922
Sponsor's protocol ID
GMMG HD6
Acronym
GMMG-HD6
Status last verified
Sep 2021
First submitted
24 Jun 2015
Last updated
10 Sep 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Mai EK, Goldschmid H, Miah K, Bertsch U, Besemer B, Hanel M, Krzykalla J, Fenk R, Schlenzka J, Munder M, Durig J, Blau IW, Huhn S, Hose D, Jauch A, Kunz C, Mann C, Weinhold N, Scheid C, Schroers R, von Metzler I, Schieferdecker A, Thomalla J, Reimer P, Mahlberg R, Graeven U, Kremers S, Martens UM, Kunz C, Hensel M, Benner A, Seidel-Glatzer A, Weisel KC, Raab MS, Salwender HJ; German-speaking Myeloma Multicenter Group (GMMG) HD6 investigators. Elotuzumab, lenalidomide, bortezomib, dexamethasone, and autologous haematopoietic stem-cell transplantation for newly diagnosed multiple myeloma (GMMG-HD6): results from a randomised, phase 3 trial. Lancet Haematol. 2024 Feb;11(2):e101-e113. doi: 10.1016/S2352-3026(23)00366-6.

    PubMed 38302221

  • Maura F, Rajanna AR, Ziccheddu B, Poos AM, Derkach A, Maclachlan K, Durante M, Diamond B, Papadimitriou M, Davies F, Boyle EM, Walker B, Hultcrantz M, Silva A, Hampton O, Teer JK, Siegel EM, Bolli N, Jackson GH, Kaiser M, Pawlyn C, Cook G, Kazandjian D, Stein C, Chesi M, Bergsagel L, Mai EK, Goldschmidt H, Weisel KC, Fenk R, Raab MS, Van Rhee F, Usmani S, Shain KH, Weinhold N, Morgan G, Landgren O. Genomic Classification and Individualized Prognosis in Multiple Myeloma. J Clin Oncol. 2024 Apr 10;42(11):1229-1240. doi: 10.1200/JCO.23.01277. Epub 2024 Jan 9.

    PubMed 38194610

  • Kauer J, Freundt EP, Schmitt A, Weinhold N, Mai EK, Muller-Tidow C, Goldschmidt H, Raab MS, Kriegsmann K, Sauer S. Stem cell collection after lenalidomide, bortezomib and dexamethasone plus elotuzumab or isatuximab in newly diagnosed multiple myeloma patients: a single centre experience from the GMMG-HD6 and -HD7 trials. BMC Cancer. 2023 Nov 21;23(1):1132. doi: 10.1186/s12885-023-11507-9.

    PubMed 37990162

  • 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.

    PubMed 31138244

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing elotuzumab, Lenalidomide and Bortezomib in people with Multiple Myeloma, run by University of Heidelberg Medical Center at 68 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02495922, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in