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

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ClinicalTrials.gov Identifier: NCT03837509
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Multiple Myeloma Drug: INCB001158 Biological: Daratumumab SC Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: An initial equal randomization of participants between INCB001158 in combination with daratumumab SC (Treatment Group A), daratumumab SC monotherapy (Treatment Group B), and INCB001158 monotherapy (Treatment Group C) will be conducted. Participants in the treatment groups B and C at confirmed disease progression will be crossed over to INCB001158 + daratumumab SC. After the equal randomization period, a response adaptive randomization design will be used to compare the objective response rate of Treatment Groups A and B with adjustments to the randomization rate based on the observed objective response rate.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 25, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 20, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Daratumumab

Arm Intervention/treatment
Experimental: INCB001158 + daratumumab SC
INCB001158 + daratumumab
Drug: 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.

Biological: 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.

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.
Biological: 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.

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.
Drug: 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.




Primary Outcome Measures :
  1. Phase 1: Number of treatment-emergent adverse events with INCB001158 in combination with daratumumab [ Time Frame: Up to approximately 2 years ]
    Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.

  2. Phase 2: Objective response rate with INCB001158 in combination with daratumumab compared to daratumumab monotherapy [ Time Frame: Up to approximately 2 years ]
    Defined as the proportion of participants with a documented response of partial response (PR) or better, per International Myeloma Working Group (IMWG) criteria.


Secondary Outcome Measures :
  1. Time to response [ Time Frame: Up to approximately 2 years ]
    Defined as the time from the first dose of study drug to the first documented response PR or better, as per IMWG criteria.

  2. Duration of response [ Time Frame: Up to approximately 2 years ]
    Defined as time from first documented response PR or better, as per IMWG criteria, until date of disease progression or death, whichever occurs first.

  3. Progression-free survival [ Time Frame: Up to approximately 3 years ]
    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.

  4. Minimal residual disease [ Time Frame: Up to approximately 2 years ]
    Defined as the percentage of MRD-negative participants.

  5. Overall survival [ Time Frame: Up to approximately 3 years ]
    Defined as the time from the first dose of study drug to the first documented response PR or better, as per IMWG criteria.

  6. Phase 2: Number of treatment-emergent adverse events with INCB001158 as monotherapy at RP2D [ Time Frame: Up to approximately 2 years ]
    Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug

  7. 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 ]
    Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug

  8. Phase 1: Objective response rate with INCB001158 in combination with daratumumab [ Time Frame: Up to approximately 2 years ]
    Defined as the proportion of participants with a documented response of partial response (PR) or better, per International Myeloma Working Group (IMWG) criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837509


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 globalmedinfo@incyte.com

Locations
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Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Sven Gogov, MD Incyte Corporation
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03837509    
Other Study ID Numbers: INCB 01158-206
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Arginase inhibitor
multiple myeloma
Daratumumab
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Daratumumab
Antineoplastic Agents