Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma

Official Title

A Phase 3 Randomized, Open Label, Multicentre Study of Isatuximab (SAR650984) in Combination With Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With High-risk Smoldering Multiple Myeloma

Summary:

Primary Objectives:

  • Safety run-in: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM)
  • Randomized Phase 3: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to lenalidomide and dexamethasone in participants with high-risk SMM

Secondary Objectives:

Safety run-in

  • To assess overall response rate (ORR)
  • To assess duration of response (DOR)
  • To assess minimal residual disease (MRD) negativity in participants achieving very good partial response (VGPR) or complete response (CR)
  • To assess time to diagnostic (SLiM CRAB) progression or death
  • To assess time to first-line treatment for multiple myeloma (MM)
  • To assess the potential immunogenicity of isatuximab
  • Impact of abnormal cytogenetic subtype

Randomized Phase 3 - Key Secondary Objectives:

To compare between the arms

  • MRD negativity
  • Sustained MRD negativity
  • Second progression-free survival (PFS2)
  • Overall survival

Other Secondary Objectives:

To evaluate in both arms

  • CR rate
  • ORR
  • DOR
  • Time to diagnostic (SLiM CRAB) progression
  • Time to first-line treatment for MM
  • Safety and tolerability
  • Pharmacokinetics (PK)
  • Potential of isatuximab immunogenicity
  • Clinical outcome assessments (COAs)

Trial Description

Primary Outcome:

  • Safety assessment: adverse events (AEs)
  • Plasma concentration of isatuximab: Cmax
  • Receptor density/receptor occupancy (safety run-in)
  • Progression-free survival (PFS) randomized Phase 3
Secondary Outcome:
  • Overall response rate (ORR)
  • Duration of response (DOR)
  • Minimal residual disease (MRD) negativity
  • Time to diagnostic (SLiM CRAB) progression or death
  • Time to first-line treatment for multiple myeloma (MM)
  • Immunogenicity: Incidence of anti-drug antibodies (ADA)
  • Sustained MRD negativity
  • Second PFS (PFS2)
  • Overall survival
  • Complete response rate
  • Safety assessment: adverse events (AEs)
  • Plasma concentration of isatuximab
  • European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
  • EORTC QLQ-MY20
  • EQ-5D-5L
  • Economic questionnaire
  • Patient's Qualitative Assessment of Treatment Version 2 (PQAT-v2)
Study duration is expected to be approximately 10 years, including a 28-day screening period, followed by an up to 36-month treatment period, and a follow-up period of approximately 7 years.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society