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NCT04786028

A Phase 2 Multi-Center, Open Label Study of Isatuximab Added to Standard CyBorD Induction and Lenalidomide Maintenance Treatments in Newly Diagnosed, Transplant Eligible Multiple Myeloma

Active, enrolled Phase 2 Last updated 7 January 2025
What this trial tests

Phase 2 trial testing Isatuximab in Multiple Myeloma in 72 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
8 December 2021
Primary endpoint
1 March 2026
1 June 2027

Quick facts

Lead sponsorCanadian Myeloma Research Group
PhasePhase 2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment72
Start date8 December 2021
Primary completion1 March 2026
Estimated completion1 June 2027
Sites7 locations across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Canadian Myeloma Research Group

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

This is a phase II multi-center, open label, single arm study to evaluate the safety and efficacy of Isatuximab administered intravenously in combination with CyBorD induction treatment and Lenalidomide maintenance treatment in a 28-day long cycle in autologous stem cell transplant-eligible patients.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Immune checkpoint modulators in cancer immunotherapy: recent advances and emerging concepts.
    Wang Y, Zhang H, Liu C, Wang Z, et al · · 2022 · cited 179× · PMID 35978433 · DOI 10.1186/s13045-022-01325-0
  2. Carfilzomib, lenalidomide, and dexamethasone or lenalidomide alone as maintenance therapy after autologous stem-cell transplantation in patients with multiple myeloma (ATLAS): interim analysis of a randomised, open-label, phase 3 trial.
    Dytfeld D, Wróbel T, Jamroziak K, Kubicki T, et al · · 2023 · cited 60× · PMID 36642080 · DOI 10.1016/s1470-2045(22)00738-0
  3. Phase 1b Study of Isatuximab in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone in Newly Diagnosed, Transplant-ineligible Multiple Myeloma Patients.
    Ocio EM, Bringhen S, Martinez-Lopez J, Martinez-Lopez J, et al · · 2023 · cited 4× · PMID 36751513 · DOI 10.1097/hs9.0000000000000829
  4. The Landscape of Currently Enrolling Maintenance Trials in Multiple Myeloma.
    Tariq SM, Abdallah AO, Goodman A, Sborov D, et al · · 2023 · cited 3× · PMID 37133718 · DOI 10.1007/s44228-023-00044-8

Verify or expand the search:

Other trials of Isatuximab

Trials testing the same drug.

Other recruiting trials for Multiple Myeloma

Currently open trials in the same condition.

Other Canadian Myeloma Research Group trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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