Multiple Myeloma Support + Trials

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 will happen during the trial?

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.

Inclusion Criteria:

Participants must have RRMM with measurable disease:
- 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.
Has undergone stem cell transplant or is considered transplant ineligible.
Has failed at least 3 prior lines of anti-myeloma treatments and is either refractory, or intolerant to at least 1 immunomodulatory drug ( 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.
Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Have recovered to Grade 1 or baseline from all toxicity associated with previous therapy or have the toxicity established as sequela.

Exclusion Criteria:

Received treatment with systemic anticancer treatments within 14 days before the first dose of study drug.
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.
Prior radiation therapy within 14 days of the first dose of TAK-981.
Major surgery within 4 weeks before C1D1. participants should be fully recovered from any surgically related complications.
Plasmapheresis within 28 days of randomization.
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.
With disease where the only measurable parameter is plasmacytoma.
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.
Prior treatment with more than 1 anti-CD38 antibody.
Requires the use of drugs known to prolong the corrected QT interval (QTc) (during Phase 1b only).
History of QT interval with Fridericia's correction (QTcF) >480 ms.
History of human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C infection.
Systemic infection requiring systemic antibiotic therapy.
Active or history pneumonitis.
Receipt of any live vaccine (eg, varicella, pneumococcus) within 4 weeks of initiation of study drug.
Receiving strong or moderate Cytochrome P450 (CYP) 3A4/5 inhibitors or inducers.
History of unstable cardiac comorbidities in the following 6 months.

Additional Trial Information

Phase 1/2

Enrollment: 81 patients (estimated)

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Interested in this trial?

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What's the purpose of this trial?

What will happen during the trial?

You may be able to join this trial if you:

Additional Trial Information

Trial Locations

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Arizona

Open and Accepting

Florida

Open and Accepting

Georgia

Not Yet Accepting

Indiana

Open and Accepting

Maryland

Not Yet Accepting

Minnesota

Open and Accepting

Nebraska

Open and Accepting

New York

Open and Accepting

Ohio

Open and Accepting

Texas

Open and Accepting

Open and Accepting

Wisconsin

Open and Accepting