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

  • STATUS
    Recruiting
  • days left to enroll
    23
  • participants needed
    151
  • sponsor
    Millennium Pharmaceuticals, Inc.
Updated on 28 January 2021
measurable disease
bone marrow procedure
dexamethasone
proteasome inhibitor
refractory multiple myeloma
plasmacytosis
plasmacytoma
immunomodulatory imide drug

Summary

The purpose of this study is to determine the safety and tolerability of single agent TAK-573 in participants with relapsed/refractory MM in Phase 1, and to provide a preliminary evaluation of the clinical activity of TAK-573 as a single agent and in combination with dexamethasone in participants with relapsed/refractory MM in Phase 2.

Description

The drug being tested in this study is called TAK-573 as single agent and in combination with dexamethasone. The study will determine the safety and tolerability of TAK-573 as single agent and in combination with dexamethasone in participants with relapsed/refractory MM. The study consists of 2 Phases, 1 and 2.

The study will enroll approximately 51 and 100 participants in Phase 1 and 2 respectively. Participants will be randomly assigned to one of the following treatment groups in each

Phase
  • Phase 1 Schedule A: TAK-573 0.001 to 14 mg/kg
  • Phase 1 Schedule B: TAK-573 TBD
  • Phase 1 Schedule C: TAK-573 TBD
  • Phase 1 Schedule D: TAK-573 TBD
  • Phase 2: TAK-573 TBD

The Phase 1 portion of the study will follow a 3+3 dose escalation design to evaluate once-weekly up to 4 different schedules of administration of TAK-573 starting at 0.001 mg/kg for DLT evaluation and to determine the maximum tolerated dose (MTD) or an optimal biological dose (OBD) for assessments in Phase 2.

The Phase 2 will further assess the safety profile of TAK-573 and its efficacy at MTD or OBD.

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.

Details
Condition Multiple Myeloma, Lymphoproliferative Disorder, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment Dexamethasone, TAK-573
Clinical Study IdentifierNCT03215030
SponsorMillennium Pharmaceuticals, Inc.
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Has MM defined by the IMWG criteria with evidence of disease progression and
In need of additional myeloma therapy as determined by the investigator
Has previously received at least 3 lines of myeloma therapy (example, containing an Immunomodulatory imide drug [IMid], a proteasome inhibitor [PI], an alkylating agent, and/or an anti-CD38 as single agents or in combination)
Has either refractory to or intolerant of at least one proteasome inhibitor and a least one immunomodulatory drug
For participants in MTD/OBD cohort expansion and Phase 2 only: participant has measurable disease
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 percent [%]) and/or plasmacytoma (>=1 centimeter [cm] in diameter) detected by physical examination or imaging
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion Criteria

Has polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma, solitary plasmacytoma, amyloidosis, Waldenstrom macroglobinemia or immunoglobulin M (IgM) myeloma, or lymphoplasmacytic lymphoma (LPL)
Has sensory or motor neuropathy of NCI CTCAE >=Grade 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
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
Has clinical signs of central nervous system involvement of MM
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