INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma
About this trial
This is an interventional treatment trial for Relapsed or Refractory Multiple Myeloma focused on measuring Arginase inhibitor, multiple myeloma, Daratumumab
Eligibility 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.
Sites / Locations
- Southern Cancer Center
- Arizona Oncology Associates (Wilmot)
- Rocky Mountain Cancer Centers
- Dana Farber Cancer Institute
- Comprehensive Cancer Centers of Nevada - Twain
- New York Oncology Hematology
- Lineberger Comprehensive Cancer Center At University of North Carolina Chapel Hill
- Oncology Hematology Care, Inc
- Texas Oncology-Austin Midtown
- Texas Oncology - Fort Worth South Henderson
- Texas Oncology San Antonio
- Texas Oncology - Tyler
- University of Virginia
- Virginia Cancer Specialists-Fairfax
- Charite - Universit�Tsmedizin Berlin
- University of Heidelberg
- Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
- Universitatsklinikum Munster
- Hospital General Universitari Vall D Hebron
- Hospital Clinic I Provincial
- Ico Institut Catala D Oncologia
- Hospital Universitario Ramon Y Cajal
- Fundacion Jimenez Diaz University Hospital
- Hospital Universitario 12 de Octubre
- Clinica Universidad de Navarra (Cun)
- Hospital Clinico Universitario de Salamanca
- Hospital Universitario Marques de Valdecilla
- Hospital Universitario Doctor Peset
- Hospital Universitario Y Politcnico de La Fe
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Experimental
INCB001158 + daratumumab SC
Daratumumab monotherapy and crossover to INC001158+ daratumumab SC
INCB001158 monotherapy and crossover to INC001158+ daratumumab SC
INCB001158 + daratumumab
Daratumumab will be administered as monotherapy, once confirmed disease progression participants will be crossed over to INCB001158+daratumumad combination therapy.
INCB001158 will be administered as monotherapy, once confirmed disease progression participants will be crossed over to INCB001158+daratumumad combination therapy.