First in Human Dose Escalation of M3258 as a Single Agent and Expansion Study of M3258 in Combination With Dexamethasone
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: M3258; M3258 20 mg
Intervention description: Participants received M3258 at a dose of 10 milligrams (mg) orally, once daily (QD) or twice per week on Day 1 and Day 4 until disease progression.; Participants received M3258 at a dose of 20 mg orally, twice per week on Day 1 and Day 4 until disease progression.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: M3258; Dexamethasone; Pharmacokinetics; Relapsed Refractory Multiple Myeloma

Summary:

      The purpose of this study was to determine the safety, tolerability, pharmacokinetics,
      pharmacodynamics and early efficacy signs of M3258 as a single agent and co-administered with
      dexamethasone in participants with Relapsed Refractory Multiple Myeloma (RRMM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants having Eastern Co-operative Oncology Group (ECOG) Performance Status less
             than or equals to (<=) 1

          -  Adequate hematological, hepatic and renal function as defined in the protocol

          -  Participant must have measurable disease of Multiple Myeloma (MM) and received greater
             than (>) 3 prior lines of therapy for MM including a Proteasome Inhibitors (PI), an
             Immunomodulatory Imide Drug (IMiD) and an anti-CD38 mAb or who are refractory to at
             least PI agent (carfilzomib or bortezomib) and IMiD according to the International
             Myeloma Working Group (IMWG) criteria

          -  Participant must have documented evidence progressive disease as defined by the IMWG
             criteria either on or after their last regimen

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          -  Any condition, including any uncontrolled disease state that in the Investigator's
             opinion constitutes an inappropriate risk or a contraindication for participation in
             the study or that could interfere with the study objectives, conduct, or evaluation.

          -  An active second malignancy or evidence of disease of cancer (other than MM) before
             the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin
             and carcinoma in situ of the cervix, or malignancy that in the opinion of the
             Investigator, with concurrence with the Sponsor's medical monitor, is considered cured
             with minimal risk of recurrence within 3 years).

          -  Cerebrovascular accident/stroke (< 6 months prior enrollment) or neurologic
             instability per clinical evaluation due to tumor involvement of the Central Nervous
             System

          -  Diagnosis of fever within 1 week prior to study intervention administration

          -  Part B: Participants planning to undergo a stem cell transplant should not be enrolled
             to reduce disease burden prior to transplant.

          -  Other protocol defined exclusion criteria could apply