Multicenter Phase 2 Study of Subcutaneous Isatuximab Plus Bortezomib, Lenalidomide and Dexamethas… (NCT05889221) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Multicenter Phase 2 Study of Subcutaneous Isatuximab Plus Bortezomib, Lenalidomide and Dexamethasone in the Treatment of Newly Diagnosed Transplant Ineligible Multiple Myeloma
France74 participantsStarted 2023-10-23
Plain-language summary
Isatuximab was developed on a sub-cutaneous (SC) administration format. SC administration is expected to be more convenient for the patient, with a much shorter duration of administration compared to the currently approved IV route.
The SC Isatuximab RP2D fixed dose was determined at 1400 mg in a phase1b assessing SC Isatuximab in combination with pomalidomide and dexamethasone in RRMM patients. A similar activity and a favorable safety administration profile compared to the IV formulation, was shown in this trial, as expected (Moreau et al, ASH 2021; Quach et al, ASCO 2022). This data should be confirmed in the ongoing IRAKLIA/EFC15951 phase 3 study, that compared in the RRMM, isatuximab plus pomalidomide and dexamethasone IV versus SC. Whether isatuximab SC, fixed 1400 mg dose, will show similar efficacy and safety profile as to anti-CD38Rd+V remains to be demonstrated. The investigators have planned to study the combination of SC isatuximab plus VRd (IsVRd) in patients with NDMM NTE in a phase 2 study across IFM (Intergroupe Francophone du Myeloma) centers in France to compare indirectly this data to the data obtained from studies that have studied this association in that population with the IV isatuximab formulation.
Who can participate
Age range65 Years
SexALL
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Inclusion criteria
✓. Must be able to understand and voluntarily sign an informed consent form
✓. Must be able to adhere to the study visit schedule and other protocol requirements
✓. Patient able to swallow the various oral treatments
✓. Life expectancy \> 6 months
✓. Subject, male or female, must be at least ≥ 65 years of age
✓. Must have a Newly diagnosed Multiple Myeloma requiring therapy (SLiM CRAB criteria) (see appendix 18.2) 6.1. Monoclonal plasma cells in the bone marrow ≥10% or presence of a biopsy proven plasmacytoma 6.2. Revised International Myeloma Working Group diagnostic criteria for multiple myeloma
✓. Must have measurable disease as defined by any of the following:
✓. Must be nontransplant eligible 8.1. Newly diagnosed and not considered candidate for high- dose chemotherapy with SCT. 8.2. Subject must have Charlson comorbidity index ≤1 8.3. ECOG ≤2
Exclusion criteria
✕
What they're measuring
1
VGPR Rate
Timeframe: The primary outcoume will be evaluate up to 8 months after the treatment after treatment has begun.
. Subject has a diagnosis of primary systemic amyloidosis, monoclonal gammopathy of undetermined significance, or smouldering multiple myeloma.
✕. Subject has a diagnosis of Waldenström's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.
✕. Subject has prior or current systemic therapy or SCT for multiple myeloma, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment.
✕. Subject has a history of ongoing malignancy (other than multiple myeloma) within 3 years (date of diagnosis of the malignancy) before inclusion in the study treatment (exceptions are malignancies considered cured with minimal risk of recurrence within 3 years, even though the patient receives treatment).
✕. Subject has had radiation therapy within 7 days study treatment\*
✕. Subject has had plasmapheresis within 7 days study treatment \*
✕. Subject is exhibiting clinical signs of meningeal involvement of multiple myeloma.
✕. Known to be seropositive for history of human immunodeficiency virus (HIV).