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

Overview

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.

SparkCures ID 1015
Trial Phase Phase 1/2
Enrollment 98 Patients
Treatments
Trial Sponsors
  • Incyte Corporation
NCT Identifier

NCT03837509

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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.

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

New York Oncology Hematology

Albany, NY

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

Verified UNC Lineberger Comprehensive Cancer Center - University of North Carolina

SparkCures Verified Accurate, up-to-date information. Learn more


Southern Cancer Center - Providence Hospital

Mobile, AL

Comprehensive Cancer Centers of Nevada (Central Valley)

Paradise, NV

Oncology Hematology Care Inc. (Kenwood)

Deer Park, OH

Texas Oncology - Austin Midtown

Austin, TX

Texas Oncology (Fort Worth)

Fort Worth, TX

Texas Oncology - San Antonio Northeast

San Antonio, TX

Texas Oncology -

Tyler, TX

UVA Cancer Center - University of Virginia Health System

Charlottesville, VA

Alabama
Southern Cancer Center - Providence Hospital

Mobile, AL

Colorado
Massachusetts
Nevada
Comprehensive Cancer Centers of Nevada (Central Valley)

Paradise, NV

New York
New York Oncology Hematology

Albany, NY

North Carolina
Verified UNC Lineberger Comprehensive Cancer Center - University of North Carolina

SparkCures Verified Accurate, up-to-date information. Learn more

Ohio
Oncology Hematology Care Inc. (Kenwood)

Deer Park, OH

Texas
Texas Oncology - Austin Midtown

Austin, TX

Texas Oncology (Fort Worth)

Fort Worth, TX

Texas Oncology - San Antonio Northeast

San Antonio, TX

Texas Oncology -

Tyler, TX

Virginia
UVA Cancer Center - University of Virginia Health System

Charlottesville, VA

International Locations

This trial has active trial locations in countries outside of the United States.

Our system currently only provides clinical trial matching services for myeloma patients in the United States.

You can view this clinical trial's international locations by visiting ClinicalTrials.gov. Please be aware that the government website may include information that is inaccurate and/or out-of-date.

Resources

There are no resources, links or videos to display for this clinical trial.