Inobrodib, Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma

This is a Phase II, open-label, multicenter study to evaluate the efficacy and safety of inobrodib in combination with pomalidomide and dexamethasone (InoPd) in patients with relapsed and refractory multiple myeloma (RRMM).

Patients must be 18 years or older and be refractory to least one proteosome inhibitor (PI), one anti-CD38 monoclonal antibody (mAb) and pomalidomide. Patients must also be previously treated with an approved bispecific T-cell engager \[TCE\].

Approximately 100 patients will be treated with 20 mg of inobrodib administered orally twice daily (b.i.d.) 4 days on / 3 days off for each 28-day cycle. Pomalidomide and dexamethasone will be administered as per standard of care (SoC), i.e., with a starting dose of 4 mg orally once daily on Day 1 to 21 of each 28-day cycle for pomalidomide, and 40 mg orally once daily on Days 1, 8, 15 and 22 for each 28-day cycle for dexamethasone. Study treatment should be continued until disease progression, initiation of new anticancer therapy, unacceptable toxicity or the patient meets any criteria for withdrawal from the study.

The primary objective is to assess the efficacy of InoPd in terms of objective response rate (ORR) based on International Myeloma Working Group (IMWG) criteria and assessed by Independent Review Committee (IRC).

• ORR, defined as the percentage of patients with a confirmed PR or better, based on IMWG criteria assessed by Investigator [Time frame: Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)]
• Duration of Response (DoR), defined as the duration of overall response by investigator and ICR [Time frame: Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)]
• Time to Response (TTR), defined as time to confirmed PR or better, by investigator and ICR [Time frame: Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)]
• Very Good Partial Response (VGPR) or better rate, defined as the percentage of patients with a confirmed VGPR or better, based on IMWG criteria and assessed by investigator and ICR [Time frame: Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)]
• Complete Response (CR) or better rate, defined as the percentage of patients with a confirmed CR or better, based on IMWG criteria and assessed by investigator and ICR [Time frame: Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)]
• Progression Free Survival (PFS), defined as the time from enrolment until the earliest date of Progressive Disease (PD), or death due to any cause, and assessed by investigator and ICR [Time frame: Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)]
• Overall Survival (OS), defined as the time from enrolment to the date of death due to any cause [Time frame: Assessed from enrollment to date of death from any cause, until the end of study (up to 48 months)]
• Incidence of treatment-emergent adverse events (TEAEs), vital signs and laboratory abnormalities [Time frame: Assessed from start of treatment until 28 days after end of treatment]