Clinical Trial 23944

• Overview

  Study Title:

  A Phase II, Open-Label, Multicenter Study of Inobrodib in Combination with Pomalidomide and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma

  Summary:

  The purpose of this study is to learn more about the anti-cancer activity of inobrodib, when given in combination with pomalidomide and dexamethasone, in patients with multiple myeloma that has come back following treatment and which no longer responds to available therapies. The study treatment will not be compared to any other treatment and patients will know what treatment they are receiving. This study will also further explore the side effects of inobrodib in combination with these other medicines.

  Objective:

  Primary Objective: To assess the efficacy of InoPd. Secondary Objectives: To further assess the efficacy of InoPd. To assess the safety and tolerability of InoPd.

• Treatments

  Therapies:

  Bioavailable inhibitor; CYP1A2 substrate; CYP2C8 Inhibitor; moderate inducer of CYP3A4.

  Medications:

  CC-4047 (Pomalidomide); Dexamethasone (); Inobrodib (); Pomalidomide ()

• Inclusion Criteria

  Inclusion Criteria:
  • Male or female ≥18 years of age
  • Prior diagnosis of MM as defined according to IMWG criteria and relapsed or refractory to the last line of therapy
  • Eastern Co-operative Oncology Group (ECOG) performance status of 0 to 2
  • Adequate hematological, renal and hepatic function
  • Willingness to use highly effective contraceptive measures (if sexually active) with all sexual partners

• Exclusion Criteria

  Exclusion Criteria:
  • Use of any investigational agent, chemotherapy, immunotherapy or anticancer agent from a previous clinical study within 14 days or 5 half-lives of first dose of study treatment, whichever is shortest; any antibody based therapy within 30 days
  • Prior treatment with p300/CBP bromodomain inhibitors
  • Known or suspected severe allergies to any active or inactive ingredients in the study medications (inobrodib, pomalidomide, dexamethasone) or any prior immunomodulatory drug (lenalidomide, thalidomide)
  • Treatment with medicines or herbal supplements or foods (e.g. strong CYP3A4 inducers or inhibitors) that would interfere with treatment
  • Major surgery within 4 weeks of the first dose of study treatment
  • Live vaccine within 4 weeks of study treatment
  • Active or unresolved adverse events
  • Active malignancies (progressing or requiring change in treatment) in the last 24 months other than multiple myeloma
  • Female patients who are pregnant or breast-feeding at any time during the study
  • Any illness or medical history that would impact safety or compliance with study requirements or impact ability to interpret study data

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