INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Relapsed or Refractory Multiple Myeloma
Stopped early · Phase 1/Phase 2
Conditions studied: Relapsed or Refractory Multiple Myeloma
In brief
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.
Key facts
- Study ID
- NCT03837509
- Run by
- Incyte Corporation
- People needed
- 15
- Starts
- 2019-09-25
- Expected to finish
- 2022-04-05
- Last updated by the study team
- 2025-11-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Southern Cancer Center — Daphne, Alabama, United States
- Arizona Oncology Associates (Wilmot) — Tucson, Arizona, United States
- Rocky Mountain Cancer Centers — Denver, Colorado, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Comprehensive Cancer Centers of Nevada - Twain — Las Vegas, Nevada, United States
- New York Oncology Hematology — Albany, New York, United States
- Lineberger Comprehensive Cancer Center At University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States
- Oncology Hematology Care, Inc — Cincinnati, Ohio, United States
- Texas Oncology-Austin Midtown — Austin, Texas, United States
- Texas Oncology - Fort Worth South Henderson — Fort Worth, Texas, United States
- Texas Oncology San Antonio — San Antonio, Texas, United States
- Texas Oncology - Tyler — Tyler, Texas, United States
- University of Virginia — Charlottesville, Virginia, United States
- Virginia Cancer Specialists-Fairfax — Fairfax, Virginia, United States
- Charite - Universit�Tsmedizin Berlin — Berlin, Germany
- University of Heidelberg — Heidelberg, Germany
- Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii — Mainz, Germany
- Universitatsklinikum Munster — Münster, Germany
- Hospital General Universitari Vall D Hebron — Barcelona, Spain
- Hospital Clinic I Provincial — Barcelona, Spain
- Ico Institut Catala D Oncologia — Barcelona, Spain
- Hospital Universitario Ramon Y Cajal — Madrid, Spain
- Fundacion Jimenez Diaz University Hospital — Madrid, Spain
- Hospital Universitario 12 de Octubre — Madrid, Spain
- Clinica Universidad de Navarra (Cun) — Pamplona, Spain
Full record on ClinicalTrials.gov
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