REST - Replacing Steroids in the Transplant Ineligble
(REST Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byFredrik H Schjesvold, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Oslo University Hospital

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Newly diagnosed multiple myeloma patients ineligible for HD-ASCT will be included in the study. All participants will receive isatuximab in combination with bortezomib, lenalidomide and minimal dexamethasone until disease progression. The primary objective of this study is the MRD negativity rate during and/or after first 18 cycles of study treatment.

Eligibility Criteria

Inclusion Criteria

Voluntary written informed consent.

Participant must be >18 years of age at the time of signing the informed consent.

Newly diagnosed multiple myeloma (IMWG criteria) in-eligible for high-dose therapy and ASCT.

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Treatment Details

Interventions

Bortezomib (Proteasome Inhibitor)
Dexamethasone (Corticosteroid)
Isatuximab (Monoclonal Antibodies)
Lenalidomide (Immunomodulatory Agent)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: NDMM ineligible for transplantExperimental Treatment1 Intervention

All participants will receive isatuximab in combination with bortezomib, lenalidomide and dexamethasone for 2 cycles, followed by isatuximab in combination with bortezomib and lenalidomide for 6 cycles, followed by isatuximab in combination with lenalidomide for 10 cycles, followed by continuous lenalidomide until disease progression. The cycle duration is 28 days. * Isatuximab will be administered IV at a dose of 10 mg/kg * on D1, D8, D15 and D22 during Cycle 1 * on D1 and D15 during Cycles 2-18 * Bortezomib will be administered SC at a dose of 1,3mg/m2 -on D1, D8 and D15 during Cycles 1-8 * Lenalidomide will be administered PO at a dose of 25mg/day (15 mg/day in participants with GFR \<30mL/minute/1.73m2) -on D1 to D21 during all Cycles. * Dexamethasone will be administered PO at a dose of 20 mg -on D1, D8, D15 and D22 during Cycles 1 and 2

Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Velcade for: