Phase 1b/2: Isatuximab, Iberdomide, Bortezomib, Dexamethasone in Transplant Ineligible/Deferred Newly Diagnosed Myeloma

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute

About this trial

This study is to evaluate the combination of isatuximab, iberdomide, bortezomib, and dexamethasone in newly diagnosed multiple myeloma participants who are transplant ineligible or not intended for upfront transplant.

The names of the study drugs used in this research study are:

isatuximab, iberdomide, bortezomib dexamethasone

Eligibility criteria

Qualifiers

Male or female, 18 years of age or older

Ability to understand and the willingness to sign a written informed consent document

NDMM based on IMWG criteria with clonal bone marrow plasma cells >10% or biopsy proven bony or extramedullary disease/plasmacytoma (EMD) with any one or more CRAB-features or myeloma defining events (Rajkumar, 2024). (See Appendix G)

Ineligible for ASCT as assessed by the treating physician or eligible but prefers and agrees to defer ASCT until after induction and maintenance therapy, upon progression or at a later time

Disqualifiers

Corticosteroids for management of MM not to exceed equivalent of 160 mg of dexamethasone in a 2-week period and should be stable 7 days prior to the registration.

Focal palliative radiation for the management of bone pain completed ≥ 7 days prior to registration

Patients with a prior history of serious allergic reactions associated with thalidomide, lenalidomide, or pomalidomide should not receive iberdomide as they could be at higher risk of hypersensitivity.

Resolution of symptoms of prior treatment to ≤ grade 1 or baseline

Trial design

Treatments tested in this trial

  • Isatuximab
  • Iberdomide
  • Bortezomib
  • Dexamethesone

Treatment groups

88 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators