Newly diagnosed symptomatic multiple myeloma MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Revlimid 5 mg
Product Name: Lenalidomide
Product Code: CC-5013
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Current Sponsor code: CC-5013
Co
Sponsors
Ruprecht-Karls-University Heidelberg, Medical Faculty represented by University Hospital Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Confirmed diagnosis of untreated multiple myeloma requiring systemic therapy (updated IMWG criteria for diagnosis of MM, 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 comorbid 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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 424 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 140
Exclusion criteria
Exclusion criteria: - Patient has known hypersensitivity to any drugs given in the protocol, notably bortezomib, lenalidomide, dexamethasone and elotuzumab or to any of the constituent compounds. - 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 - Significant hepatic dysfunction - 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 - Platelet count < 75 x 10^9/l, or, dependent on bone marrow infiltration by plasma cells, platelet count < 30 x 10^9/l - Haemoglobin < 8.0 g/dl, unless related to myeloma - Absolute neutrophil count (ANC) < 1.0 x 10^9/l
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is the determination of the best of four treatment strategies regarding progression-free survival (PFS). The four treatment strategies are 1. (arm A1): VRD (Bortezomib (Velcade) / Lenalidomide (Revlimid) / Dexamethasone) induction, standard intensification, VRD consolidation and lenalidomide maintenance 2. (arm A2): VRD induction, standard intensification, VRD + elotuzumab consolidation and lenalidomide maintenance + elotuzumab 3. (arm B1): VRD + elotuzumab induction, standard intensification, VRD consolidation and lenalidomide maintenance 4. (arm B2): VRD + elotuzumab induction, standard intensification, VRD + elotuzumab consolidation and lenalidomide maintenance + elotuzumab;Secondary Objective: The secondary objectives of this trial are to assess and to compare treatment arms regarding - overall survival (OS) - CR rates after induction therapy - CR rates after consolidation treatment - PFS censored at end of trial - best response to treatment during the study - time to progression (TTP), censored at end of trial - duration of response (DOR), censored at end of trial - toxicity during induction treatment, consolidation and maintenance treatment with respect to adverse events of CTCAE grade > = 3 - Quality of life assessment;Primary end point(s): Progression-free survival (PFS) - defined as time from randomisation to progression or death from any cause whichever occurs first, censored at the end of the trial.;Timepoint(s) of evaluation of this end point: Response evaluation at different time points: - after Induction - after standard intensification - after consolidation - in maintenance every three months - in follow up: every three months until progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - OS defined as 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. - response rates after induction therapy comparing the two arms VRD (A1+A2) vs VRD+elotuzumab (B1+B2). The analysis will be based on the CR rate which is the proportion of patients achieving complete response (CR) to treatment after induction therapy. - CR rates after consolidation therapy - best response during the study - TTP, censored at the end of the trial - DOR, censored at the end of the Trial - Quality of life assessment during induction, consolidation and maintenance therapy Safety will be analysed including - toxicity (CTC grade >= 3) during induction therapy, VRD/VRD+elotuzumab consolidation and lenalidomide/lenalidomide+elotuzumab maintenance therapy, respectively, measured by CTC-AE (v4.0);Timepoint(s) of evaluation of this end point: any time | — |
Countries
Germany
Contacts
Public ContactGMMG Studiensekretariat
GMMG Study Office
Outcome results
None listed