Overview

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

Status:
Terminated
Trial end date:
2021-06-29
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Incyte Corporation
Treatments:
Antibodies, Monoclonal
Daratumumab
Criteria
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.