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NCT02495922 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2021-09-10

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
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.
healthy Volunteers
false
maximum Age
70 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. 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).
    intervention Names
    1. Drug: Lenalidomide
    2. Drug: Bortezomib
    3. Drug: Dexamethasone
    label
    A1
    type
    ACTIVE_COMPARATOR
  2. 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).
    intervention Names
    1. Drug: elotuzumab
    2. Drug: Lenalidomide
    3. Drug: Bortezomib
    4. Drug: Dexamethasone
    label
    A2
    type
    EXPERIMENTAL
  3. 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).
    intervention Names
    1. Drug: elotuzumab
    2. Drug: Lenalidomide
    3. Drug: Bortezomib
    4. Drug: Dexamethasone
    label
    B1
    type
    EXPERIMENTAL
  4. 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 Names
    1. Drug: elotuzumab
    2. Drug: Lenalidomide
    3. Drug: Bortezomib
    4. Drug: Dexamethasone
    label
    B2
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. A2
    2. B1
    3. B2
    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)
    name
    elotuzumab
    type
    DRUG
  2. arm Group Labels
    1. A1
    2. A2
    3. B1
    4. B2
    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)
    name
    Lenalidomide
    other Names
    1. Revlimid
    type
    DRUG
  3. arm Group Labels
    1. A1
    2. A2
    3. B1
    4. B2
    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
    name
    Bortezomib
    other Names
    1. Velcade
    type
    DRUG
  4. arm Group Labels
    1. A1
    2. A2
    3. B1
    4. B2
    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).
    name
    Dexamethasone
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
564
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    response evaluation
    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)
secondary Outcomes
  1. description
    survival status
    measure
    overall survival
    time Frame
    time from randomisation to time of death from any cause. Patients still being alive at the time of the analysis will be censored at the date last known to be alive. (assessed up to 80 months)
  2. description
    response evaluation
    measure
    complete response rates after induction
    time Frame
    approx. after 3 months (after induction therapy)
  3. description
    response evaluation
    measure
    complete response rates after consolidation
    time Frame
    approx. after 9 months (after consolidation therapy)
  4. description
    response evaluation
    measure
    Progression Free Survival after end of trial
    time Frame
    time from randomisation to progression or death from any cause whichever comes first, censored at the end date of the trial (i.e. assessed up to 80 months)
  5. description
    response evaluation
    measure
    best response to treatment during the study
    time Frame
    response assessment after ca. 3 months, 4 months, 7 months, 9 months,11 months, 14 months, and subsequently every 3 months during maintenance treatment, up to 35 months after start of study treatment.
  6. description
    Response evaluation
    measure
    time to progression, censored at end of the trial
    time Frame
    From date of randomization until the date of first documented progression, assessed up to 80 months
  7. description
    response evaluation
    measure
    duration of response, censored at end of the trial
    time Frame
    assessed up to 80 months
  8. description
    toxicity according CTCAE Version 4.0
    measure
    toxicity during induction treatment, consolidation and maintenance treatment with respect to adverse Events of CTCAE grade 3 or higher
    time Frame
    from first administration of study drug until 40 days after last administration of study drug or any drug of the study treatment or upon start of a new subsequent chemotherapy, whichever occurs first
  9. description
    Questionnaires EORTC-QLQC30 and EORTC-QLQMY20
    measure
    Quality of Life assessment
    time Frame
    assessed at baseline, after ca. 3 months, 7 months, 9 months, subsequently every 6 months, up to 36 months
Full 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).
Source references
references
  1. citation
    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.
    pmid
    38302221
    type
    DERIVED
  2. citation
    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.
    pmid
    38194610
    type
    DERIVED
  3. citation
    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.
    pmid
    37990162
    type
    DERIVED
  4. 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.
    pmid
    31138244
    type
    DERIVED
Source notices and limitations
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      1. context exact
        HL in the NCIC study [<a href="#cit/section_6.2">2</a>] at 11 years is equivalent to the survival reported at 11 years in the GHSG's <a href="/clinicaltrials/NCT02495922">HD6</a> (NCT00002561), <a href="/clinicaltrials/NCT00265018">HD10</a> (NCT01399931), and <a href="/clinicaltrials/NCT00264953">HD11</a> (NCT0264953) trials us
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      source title
      Hodgkin Lymphoma Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: February 12, 2025
        datetime
        2025-02-12T12:00:00Z
        display
        February 12, 2025

    Preserved source evidence · Not medical advice