2024-513464-26-00
Active, not recruiting
Phase 3
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 (GMMG-HD7)
Universitaetsklinikum Heidelberg AöR67 sites in 1 country662 target enrollmentStarted: July 31, 2024Last updated:
Overview
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Universitaetsklinikum Heidelberg AöR
- Enrollment
- 662
- Locations
- 67
- Primary Endpoint
- The study will investigate two primary endpoints:(1) minimal residual disease (MRD) negativity after induction (assessed by flow cytometry; sensitivity 1e-5), defined as proportion of patients with negative MRD after induction.
Overview
Brief Summary
The two primary objectives are: (1) to compare the induction regimen (IA vs IB) regarding minimal residual disease (MRD) negativity after induction (assessed by flow cytometry; sensitivity 1e-5), and (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.
Study Design
- Allocation
- Randomized
- Primary Purpose
- Maintenance
- Masking
- None
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients meeting all of the following criteria will be considered for admission to the trial:
- •Ability of patient to understand character and individual consequences of the clinical trial.
- •Provide written informed consent (must be available before enrolment in the trial).
- •Confirmed diagnosis of untreated multiple myeloma requiring systemic therapy.
- •Patient is eligible for high dose therapy and autologous stem cell transplantation.
- •Measurable disease, defined as any quantifiable monoclonal protein value, defined by at least one of the following three measurements:34 • Serum M-protein ≥ 10g/l (for IgA ≥ 5g/l) • Urine light-chain (M-protein) of ≥ 200 mg/24 hours • Serum FLC assay: involved sFLC level ≥ 10 mg/dl and abnormal sFLC ratio
- •Age 18 - 70 years inclusive
- •WHO performance status 0-2
- •Negative pregnancy test at inclusion (females of childbearing potential).
- •All patients must agree on the requirements regarding the lenalidomide pregnancy prevention plan described in section
Exclusion Criteria
- •Patients presenting with any of the following criteria will not be included in the trial:
- •Patients with active, uncontrolled infections
- •Patients with severe renal insufficiency (Creatinine Clearance < 30ml/min)
- •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)
- •Patients with a history of active malignancy during the past 5 years with the exception of the following malignancies after curative therapy: basal cell carcinoma of the skin, squamous cell skin carcinoma, stage 0 cervical carcinoma or any in situ malignancy (A history of an early stage malignancy during the past 5 years may be acceptable. In this case the GMMG study office has to be consulted prior to study inclusion.)
- •Patients with acute diffuse infiltrative pulmonary and/or pericardial disease
- •Autoimmune hemolytic anemia with positive Coombs test or immune thrombocytopenia
- •Platelet count < 75 x 10^9/l (Platelet transfusions are not permitted to improve platelet count prior to study inclusion.)
- •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)
Outcomes
Primary Outcomes
The study will investigate two primary endpoints:(1) minimal residual disease (MRD) negativity after induction (assessed by flow cytometry; sensitivity 1e-5), defined as proportion of patients with negative MRD after induction.
The study will investigate two primary endpoints:(1) minimal residual disease (MRD) negativity after induction (assessed by flow cytometry; sensitivity 1e-5), defined as proportion of patients with negative MRD after induction.
(2) progression-free survival (PFS), defined as time from 2nd randomization (prior to maintenance) to progression or death from any cause whichever occurs first.
(2) progression-free survival (PFS), defined as time from 2nd randomization (prior to maintenance) to progression or death from any cause whichever occurs first.
Secondary Outcomes
- Key Secondary Endpoint: PFS, defined as time from 1st randomization (at study inclusion) to progression or death from any cause whichever occurs first.
- OS defined as time from 1st randomization and from 2nd randomization 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.
- Complete response (CR) rates. The analysis will be based on the CR rate which is the proportion of patients achieving complete response (CR) to treatment adjusted after removal of isatuximab interference in the immunofixation test in the relevant patient subpopulations.
- MRD negativity after high dose therapy, during and after 3 years of maintenance treatment (flow cytometry) defined as the proportion of patients with negative MRD after high dose therapy, during and after 3 years of maintenance treatment (flow cytometry), respectively.
- Sustained MRD-negativity, defined as the maintenance of MRD-negativity (assessed by NGF at a sensitivity of 10-5) >=6 / >=12 months apart (after first occurrence of MRD negativity)
- best response to treatment during the trial (adjusted after removal of isatuximab interference in the immunofixation test in the relevant patient subpopulations).
- PFS 2 (PFS after next line of therapy) from 2nd randomization
- quality of life
Investigators
GMMG Studiensekretariat
Scientific
Universitaetsklinikum Heidelberg AöR
Study Sites (67)
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