Clinical Trials /

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

NCT03837509

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 who have received at least 3 but not more than 5 prior lines of multiple myeloma therapy.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
INCB001158INCB001158 + daratumumab SC
INCB001158INCB001158 monotherapy cross over INCB001158 + daratumumab SC
Daratumumab SCINCB001158 + 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 who have received at least 3 but not more than 5 prior lines of multiple myeloma therapy.

Trial Arms

NameTypeDescriptionInterventions
INCB001158 + daratumumab SCExperimental
  • INCB001158
  • Daratumumab SC
Daratumumab monotherapyActive Comparator
  • Daratumumab SC
INCB001158 monotherapy cross over INCB001158 + daratumumab SCExperimentalINCB001158 monotherapy, then cross over to INCB001158 + daratumumab SC
  • INCB001158
  • Daratumumab SC

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.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • Arginase inhibitor
  • multiple myeloma
  • recombinant human immunoglobulin G monoclonal antibody

Last Updated

October 3, 2019