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

Part of paid clinical trials in Daphne, Alabama.

Sponsor
Incyte Corporation
Study ID
NCT03837509
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Relapsed or Refractory Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • INCB001158 — DRUG
    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 SC — BIOLOGICAL
    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.

Study Details

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 Dates

Start date
Sep 25, 2019
Status verified
Oct 2025
Primary completion
Apr 5, 2022
Completion
Apr 5, 2022

Study Design

Enrollment
15 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: INCB001158 + daratumumab SC
    INCB001158 + daratumumab
  • Active Comparator: 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.
  • Experimental: 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.

Primary Outcome Measure

Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) [ Time Frame: up to 454 days ]

Locations (14)

FacilityCityStateZIPSite coordinators
Southern Cancer CenterDaphneAlabama36526-
Arizona Oncology Associates (Wilmot)TucsonArizona85711-
Rocky Mountain Cancer CentersDenverColorado80218-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Comprehensive Cancer Centers of Nevada - TwainLas VegasNevada89169-
New York Oncology HematologyAlbanyNew York12206-
Lineberger Comprehensive Cancer Center At University of North Carolina Chapel HillChapel HillNorth Carolina27514-
Oncology Hematology Care, IncCincinnatiOhio45236-
Texas Oncology-Austin MidtownAustinTexas78705-
Texas Oncology - Fort Worth South HendersonFort WorthTexas76104-
Texas Oncology San AntonioSan AntonioTexas78240-
Texas Oncology - TylerTylerTexas75702-
University of VirginiaCharlottesvilleVirginia22903-
Virginia Cancer Specialists-FairfaxFairfaxVirginia22031-

Find similar trials in Daphne, AL

By research site
Southern Cancer Center· Daphne, ALArizona Oncology Associates (Wilmot)· Tucson, AZRocky Mountain Cancer Centers· Denver, CODana Farber Cancer Institute· Boston, MAComprehensive Cancer Centers of Nevada - Twain· Las Vegas, NVNew York Oncology Hematology· Albany, NY

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