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

  • STATUS
    Recruiting
  • End date
    Oct 2, 2025
  • participants needed
    81
  • sponsor
    Takeda
Updated on 11 July 2021

Summary

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.

Participants will be on this combination treatment for 28-day cycles. They will continue with this treatment until disease progression or unacceptable toxicity.

Description

The drug being tested in this study is called TAK-981. TAK-981 in combination with an anti-CD38 monoclonal antibody is being tested to treat people who have RRMM. The study will include a dose escalation phase and a dose expansion phase.

The study will enroll approximately 81 patients, approximately 30 participants in the dose escalation phase (Part 1) approximately 15 participants in (Part 2) and up to 36 participants in dose expansion phase (Part 2). Participants will receive escalating doses of TAK-981 in combination of fixed doses as follows:

  • Phase 1, Part 1 - Dose Escalation: Arm A - TAK-981 Twice Weekly (BIW) + Mezagitamab
  • Phase 1, Part 1 - Dose Escalation: Arm B - TAK-981 Weekly (QW) + Mezagitamab
  • Phase 1, Part 2 - Dose Escalation: TAK-981 + Daratumumab and Hyaluronidase-fihj

Once RP2D is determined in Phase 1, participants with RRMM will be enrolled in Phase 2.

Phase 2 - Dose Expansion: TAK-981 + Daratumumab and Hyaluronidase-fihj or Mezagitamab

This multi-center trial will be conducted in North America. The overall time to participate in this study is 48 months. Participants will make multiple visits to the clinic, and progression-free survival follow-up for maximum up to 12 months after last dose of study drug.

Details
Condition Relapsed and/or Refractory Multiple Myeloma (RRMM), Relapsed and/or Refractory Multiple Myeloma (RRMM), Relapsed and/or Refractory Multiple Myeloma (RRMM), Relapsed and/or Refractory Multiple Myeloma (RRMM), Relapsed and/or Refractory Multiple Myeloma (RRMM), Relapsed and/or Refractory Multiple Myeloma (RRMM), Relapsed and/or Refractory Multiple Myeloma (RRMM), Relapsed and/or Refractory Multiple Myeloma (RRMM)
Treatment TAK-981, Daratumumab and Hyaluronidase-fihj, Mezagitamab
Clinical Study IdentifierNCT04776018
SponsorTakeda
Last Modified on11 July 2021

Eligibility

Yes No Not Sure

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 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, Waldenstrm'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 1 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 within 4 weeks of initiation of study drug
\. Receiving strong or moderate Cytochrome P450 (CYP3A4/5) inhibitors or
inducers
\. History of unstable cardiac comorbidities in the following 6 months
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