Description:
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.
Title
- Brief Title: INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Relapsed or Refractory Multiple Myeloma
- Official Title: A Randomized Open-Label Phase 1/2 Study of INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Participants With Relapsed or Refractory Multiple Myeloma
Clinical Trial IDs
- ORG STUDY ID:
INCB 01158-206
- NCT ID:
NCT03837509
Conditions
- Relapsed or Refractory Multiple Myeloma
Interventions
Drug | Synonyms | Arms |
---|
INCB001158 | | INCB001158 + daratumumab SC |
Daratumumab SC | | Daratumumab monotherapy and crossover to INC001158+ daratumumab SC |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
INCB001158 + daratumumab SC | Experimental | INCB001158 + daratumumab | |
Daratumumab monotherapy and crossover to INC001158+ daratumumab SC | Active Comparator | Daratumumab will be administered as monotherapy, once confirmed disease progression participants will be crossed over to INCB001158+daratumumad combination therapy. | |
INCB001158 monotherapy and crossover to INC001158+ daratumumab SC | Experimental | INCB001158 will be administered as monotherapy, once confirmed disease progression participants will be crossed over to INCB001158+daratumumad combination therapy. | |
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Phase 1: Number of treatment-emergent adverse events with INCB001158 in combination with daratumumab |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. |
Secondary Outcome Measures
Measure: | Time to response |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Defined as the time from the first dose of study drug to the first documented response PR or better, as per IMWG criteria. |
Measure: | Duration of response |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Defined as time from first documented response PR or better, as per IMWG criteria, until date of disease progression or death, whichever occurs first. |
Measure: | Progression-free survival |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | Defined as the duration from the date of first dose of study drug until either progressive disease (PD), as per IMWG criteria, or death, whichever occurs first. |
Measure: | Minimal residual disease |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Defined as the percentage of MRD-negative participants. |
Measure: | Overall survival |
Time Frame: | Up to approximately 3 years |
Safety Issue: | |
Description: | Defined as the time from the first dose of study drug to the first documented response PR or better, as per IMWG criteria. |
Measure: | Phase 2: Number of treatment-emergent adverse events with INCB001158 as monotherapy at RP2D |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug |
Measure: | Phase 2: Compare Number of treatment-emergent adverse events of INCB001158 in combination with daratumumab SC to daratumumab SC monotherapy. |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug |
Measure: | Phase 1: Objective response rate with INCB001158 in combination with daratumumab |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Defined as the proportion of participants with a documented response of partial response (PR) or better, per International Myeloma Working Group (IMWG) criteria |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | Incyte Corporation |
Trial Keywords
- Arginase inhibitor
- multiple myeloma
- Daratumumab
Last Updated
July 2, 2021