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

• Status: Recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Millennium Pharmaceuticals, Inc.
• Treatments: Dexamethasone

Criteria

Inclusion Criteria:

1. 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.

2. For participants in MTD/OBD 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 percent [%]) 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 1.

Exclusion Criteria:

1. 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).

2. Has sensory or motor neuropathy of 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 involvement of MM.