A Study Of TAK-981 Given With Monoclonal Antibodies In Adults With Relapsed or Refractory Multiple Myeloma

What's the purpose of this trial?

TAK-981 is being tested in combination with anti-CD38 monoclonal antibodies to treat participants who have relapsed or refractory multiple myeloma.  The main aims of the study are to evaluate the safety and efficacy of TAK-981 in combination with anti-CD38 monoclonal antibodies.

This trial is currently open and accepting patients.


What's being studied?

  • Daratumumab is a monoclonal antibody that targets and attaches to the CD38 protein that may be found on multiple myeloma cells.
  • Mezagitamab is a monoclonal antibody that targets and attaches to the CD38 protein that may be found on multiple myeloma cells.
  • TAK-981 is a first-in-class inhibitor of the SUMOylation enzymatic cascade being developed for the treatment of multiple myeloma.

Additional Trial Information

Phase 1/2

Enrollment: 81 patients (estimated)

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You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required. Create your account or call us today for help (888) 828-2206.

Inclusion Criteria:

  1. Participants must have RRMM with measurable disease:
    1. Has measurable disease defined as one of the following:
      • Serum M-protein ≥0.5 g/dL (≥5 g/L).
      • Urine M-protein ≥200 mg/24 hours.
      • In participants without measurable M-protein in serum protein electrophoresis (SPEP) or urine protein electrophoresis (UPEP), a serum free light chain (FLC) assay result with involved FLC level ≥10 mg/dL (≥100 mg/L), provided serum FLC ratio is abnormal.
    2. Has undergone stem cell transplant or is considered transplant ineligible.
    3. Has failed at least 3 prior lines of anti-myeloma treatments and is either refractory, or intolerant to at least 1 IMiD (ie, lenalidomide or pomalidomide [thalidomide excluded]), at least 1 proteasome inhibitor (ie, bortezomib, ixazomib or carfilzomib), and refractory to at least 1 anti-CD38 antibody and who have demonstrated disease progression with the last therapy.
  2. Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
  3. Have recovered to Grade 1 or baseline from all toxicity associated with previous therapy or have the toxicity established as sequela.

Exclusion Criteria:

  1. Received treatment with systemic anticancer treatments within 14 days before the first dose of study drug.
  2. Current participation in another interventional study, including other clinical trials with investigational agents (including investigational vaccines or investigational medical device for disease under study). within 4 weeks of the first dose of TAK-981 and throughout the duration of this trial.
  3. Prior radiation therapy within 14 days of the first dose of TAK-981.
  4. Major surgery within 4 weeks before C1D1. participants should be fully recovered from any surgically related complications.
  5. Plasmapheresis within 28 days of randomization.
  6. Diagnosis of primary amyloidosis, Waldenström's disease, monoclonal gammopathy of undetermined significance or smoldering multiple myeloma (SMM), plasma cell leukemia POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), myelodysplastic syndrome, or myeloproliferative syndrome.
  7. With disease where the only measurable parameter is plasmacytoma.
  8. Second malignancy within the previous 3 years, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, cervical carcinoma in situ, resected colorectal adenomatous polyps, breast cancer in situ, or other malignancy for which the participant is not on active anticancer therapy.
  9. Prior treatment with more than 1 anti-CD38 antibody.
  10. Requires the use of drugs known to prolong the corrected QT interval (QTc) (during Phase 1 only).
  11. History of QT interval with Fridericia's correction (QTcF) >480 ms.
  12. History of human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C infection.
  13. Systemic infection requiring systemic antibiotic therapy.
  14. Active or history pneumonitis.
  15. Receipt of any live vaccine within 4 weeks of initiation of study drug.
  16. Receiving strong or moderate Cytochrome P450 (CYP3A4/5) inhibitors or inducers.
  17. History of unstable cardiac comorbidities in the following 6 months.
View Additional Criteria

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arizona

Mayo Clinic (Scottsdale)

Scottsdale, AZ

Not Yet Accepting

California

University of California Davis Comprehensive Cancer Center

Sacramento, CA

Not Yet Accepting

Florida

Mayo Clinic (Jacksonville)

Jacksonville, FL

Not Yet Accepting

Georgia

Winship Cancer Institute of Emory University

Atlanta, GA

Not Yet Accepting

Indiana

Indiana University Health

Indianapolis, IN

Not Yet Accepting

Massachusetts

Dana-Farber Cancer Institute

Boston, MA

Not Yet Accepting

Minnesota

Mayo Clinic (Rochester)

Rochester, MN

Not Yet Accepting

Nebraska

Nebraska Cancer Specialists (Omaha)

Omaha, NE

Not Yet Accepting

North Carolina

Wake Forest Baptist Comprehensive Cancer Center Wake Forest School of Medicine

Winston-Salem, NC

Not Yet Accepting

Ohio

TriHealth Cancer Institute (Good Samaritan Hospital)

Cincinnati, OH

Not Yet Accepting

Texas

Baylor Charles A. Sammons Cancer Center Baylor Scott & White Health

Dallas, TX

Not Yet Accepting

Texas Oncology

Tyler, TX

Not Yet Accepting

Wisconsin

Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Not Yet Accepting
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