INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Relapsed or Refractory Multiple Myeloma
NCT ID: NCT03837509
Last Updated: 2025-11-04
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
15 participants
INTERVENTIONAL
2019-09-25
2022-04-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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INCB001158 + daratumumab SC
INCB001158 + daratumumab
Daratumumab SC
Daratumumab 1800 mg co-formulated with rHuPH20 (2000 U/mL) and administered subcutaneously once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and then once every 4 weeks. Daratumumab will be administered either as monotherapy or in combination with INCB001158.
INCB001158
Phase 1: INCB001158 administered orally twice daily at the protocol-defined starting dose, with dose escalation/de-escalation based on protocol-defined toxicity criteria to determine the maximum tolerated dose. INCB001158 is administered in combination with daratumumab SC. Phase 2: INCB001158 administered orally at the recommended dose from Phase 1 either as a monotherapy or in combination with daratumumab SC.
Daratumumab monotherapy and crossover to INC001158+ daratumumab SC
Daratumumab will be administered as monotherapy, once confirmed disease progression participants will be crossed over to INCB001158+daratumumad combination therapy.
Daratumumab SC
Daratumumab 1800 mg co-formulated with rHuPH20 (2000 U/mL) and administered subcutaneously once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and then once every 4 weeks. Daratumumab will be administered either as monotherapy or in combination with INCB001158.
INCB001158 monotherapy and crossover to INC001158+ daratumumab SC
INCB001158 will be administered as monotherapy, once confirmed disease progression participants will be crossed over to INCB001158+daratumumad combination therapy.
INCB001158
Phase 1: INCB001158 administered orally twice daily at the protocol-defined starting dose, with dose escalation/de-escalation based on protocol-defined toxicity criteria to determine the maximum tolerated dose. INCB001158 is administered in combination with daratumumab SC. Phase 2: INCB001158 administered orally at the recommended dose from Phase 1 either as a monotherapy or in combination with daratumumab SC.
Interventions
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Daratumumab SC
Daratumumab 1800 mg co-formulated with rHuPH20 (2000 U/mL) and administered subcutaneously once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and then once every 4 weeks. Daratumumab will be administered either as monotherapy or in combination with INCB001158.
INCB001158
Phase 1: INCB001158 administered orally twice daily at the protocol-defined starting dose, with dose escalation/de-escalation based on protocol-defined toxicity criteria to determine the maximum tolerated dose. INCB001158 is administered in combination with daratumumab SC. Phase 2: INCB001158 administered orally at the recommended dose from Phase 1 either as a monotherapy or in combination with daratumumab SC.
Eligibility Criteria
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Inclusion 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
* 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.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Sven Gogov, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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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
Hospital Clinico Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Hospital Universitario Doctor Peset
Valencia, , Spain
Hospital Universitario Y Politcnico de La Fe
Valencia, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-004076-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 01158-206
Identifier Type: -
Identifier Source: org_study_id
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