A Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-573 in Participants With Refractory Multiple Myeloma

Overview

The drug being tested in this study is called TAK-573. TAK-573 is being tested to treat participants who have refractory MM. The study consists of 2 Phases, 1 and 2a. The study will enroll approximately 51 and 18 participants in Phase 1 and 2a respectively.

Participants will be randomly assigned (by chance, like flipping a coin) to one of the following treatment groups in each Phase:

  • Phase 1: TAK-573 0.001 mg/kg

  • Phase 1: TAK-573 0.01 mg/kg

  • Phase 1: TAK-573 0.1 mg/kg

  • Phase 1: TAK-573 0.2 mg/kg

  • Phase 1: TAK-573 0.4 mg/kg

  • Phase 1: TAK-573 0.8 mg/kg

  • Phase 1: TAK-573 1.6 mg/kg

  • Phase 1: TAK-573 3 mg/kg

  • Phase 1: TAK-573 6 mg/kg

  • Phase 1: TAK-573 10 mg/kg

  • Phase 1: TAK-573 15 mg/kg

  • Phase 2: TAK-573 TBD

The Phase 1 portion of the study will follow a 3+3 dose escalation design to evaluate once-weekly administration of TAK-573 for DLT and to determine the maximum tolerated dose (MTD) for assessments in Phase 2a. This multi-center trial will be conducted in the United States. The maximum treatment duration in this study is up to 12 months and overall time to participate in the study is approximately up to 40 months. Participants will make 31 visits to the clinic, and will be contacted every 12 weeks for post treatment follow-up. Participants will be followed up for survival until death, loss to follow-up, consent withdrawal, or study termination by the sponsor, whichever occurs first.

SparkCures ID 907
Trial Phase Phase 1/2
Enrollment 69 Patients
Treatments
Trial Sponsors
  • Takeda Oncology
NCT Identifier

NCT03215030

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:

  1. Has MM defined by the IMWG criteria with evidence of disease progression and:
    • Is in need of additional myeloma therapy as determined by the investigator.
    • Has previously received at least 3 lines of myeloma therapy.
    • Is either refractory to or intolerant of at least one protesome inhibitor and a least one immunomodulatory drug.

    In addition, after the MTD is defined, must also be either refractory to or intolerant of at least one anti-CD38 monoclonal antibody.

  2. For participants in MTD cohort expansion and Phase 2 only: participant has measurable disease.
  3. During dose escalation only, participants not meeting the above criteria for measurable disease should, at least, have measurable bone marrow plasmacytosis (greater than or equal to [>=] 10%) and/or plasmacytoma (>=1 centimeter [cm] in diameter) detected by physical examination or imaging.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

Exclusion Criteria:

  1. Has polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma, solitary plasmacytoma, amyloidosis, Waldenström macroglobinemia or immunoglobulin M (IgM) myeloma, or lymphoplasmacytic lymphoma (LPL).
  2. Has sensory or motor neuropathy of >= National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) Grade 3.
  3. Who have received autologous stem cell transplant (SCT) 60 days before first infusion of TAK-573 or participants who have received allogeneic SCT 6 months before first infusion. Graft-versus-host disease that is active or requires ongoing systemic immunosuppression.
  4. Has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE less than or equal to (<=) Grade 1 or baseline, except for sensory or motor neuropathy which should have recovered to <=Grade 2 or baseline.
  5. Has clinical signs of central nervous system (CNS) involvement of MM.

US Trial Locations

Accepting Patients

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

Not Currently Accepting Patients

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

Georgia
Verified Winship Cancer Institute of Emory University -

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Ohio
Pennsylvania
Washington

Resources

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