INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Relapsed or Refractory Multiple Myeloma

A Randomized Open-Label Phase 1/2 Study of INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to evaluate the safety and antitumor activity of INCB001158 in combination with daratumumab SC, compared with daratumumab SC alone, in participants with relapsed or refractory multiple myeloma.

Inclusion Criteria:

• Prior diagnosis of multiple myeloma according to IMWG diagnostic criteria.
• Measurable disease at screening.
• Has received at least 3 but not more than 5 prior lines of multiple myeloma treatment, including proteasome inhibitor, immunomodulatory drug, and anti-CD38 therapies.
• Eastern Cooperative Oncology Group performance status of 0 or 1.
• Willing to avoid pregnancy or fathering children.
• Willing to provide fresh and archival bone marrow aspiration and biopsy tissue.

Exclusion Criteria:

• Receipt of any of the following treatment within the indicated interval before the first administration of study drug:

  • Anti-myeloma treatment within 2 weeks or 5 half-lives (whichever is longer).
  • Investigational drug (including investigational vaccines) or invasive investigational medical device within 4 weeks.
  • Autologous stem cell transplant within 12 weeks, or allogeneic stem cell transplant at any time.
  • Plasmapheresis within 4 weeks.
  • Radiation therapy within 2 weeks.
  • Major surgery within 2 weeks, or inadequate recovery from an earlier surgery, or surgery planned during the time the participant is expected to participate in the study or within 2 weeks after the last dose of study treatment.

• Toxicity ≥ Grade 2 from previous anti-myeloma therapy except for stable chronic toxicities (≤ Grade 2) not expected to resolve, such as stable Grade 2 peripheral neuropathy.

• Known additional malignancy (other than multiple myeloma) that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry.

• Laboratory values at screening outside the protocol-defined range.

• Significant concurrent, uncontrolled medical condition including but not limited to known chronic obstructive pulmonary disease (COPD), persistent asthma, or history of asthma within the past 2 years; chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment; acute diffuse infiltrative pulmonary disease; clinically significant or uncontrolled cardiac disease.

• Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or amyloidosis.