CompletedPhase 1

A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM)

United States50 participantsStarted 2019-07-29

Plain-language summary

The purpose of this original study is to determine the recommended phase 2 dose (RP2D) of TAK-079 when administered to participants with NDMM in combination with the backbone treatment regimen. The purpose of the safety/access cohort is to provide continued access to TAK-079 to participants previously enrolled to a TAK-079 parent study and to evaluate the long-term safety profile of TAK-079.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Must have previously untreated multiple myeloma (MM) as defined by the IMWG criteria requiring treatment according to the investigator.
✓. Are appropriate candidates for either the VRd or Rd backbone antimyeloma therapy according to the investigator.
✓. Must have measurable disease defined by at least 1 of the following:
✓. Participants receiving lenalidomide must be able to take concurrent prophylactic anticoagulation per standard clinical practice as directed by the investigator.
✓. Life expectancy \>3 months.
✓. Eastern Cooperative Oncology Group (ECOG) performance status score less than or equal to (\<=) 2.

Exclusion criteria

✕. Prior systemic therapy for MM.
✕. Current participation in another interventional study, including other clinical trials with investigational agents (including investigational vaccines or investigational medical device) within 4 weeks of the first dose of TAK-079 or any agent in the backbone regimen and throughout the duration of this trial.
✕. Prior radiation therapy within 14 days of the first dose of TAK-079 or any backbone regimen agents.
✕. Major surgery within 4 weeks before Cycle 1 Day 1 (kyphoplasty is not considered major surgery). Participants should be fully recovered from any surgically related complications.
✕

What they're measuring

Treatment Phase: RP2D of TAK-079

Timeframe: Up to Cycle 1 (Cycle length is equal to [=] 28 days)

Safety Extension Phase: Number of Participants Reporting one or More Serious Adverse Events (SAEs)

Timeframe: From first dose up to 30 days after the last dose of study drug (up to 4 years)

Safety Extension Phase: Number of Participants With Grade 3 or Higher Treatment-emergent Adverse Events (TEAEs)

Timeframe: From first dose up to 30 days after the last dose of study drug (up to 4 years)

Safety Extension Phase: Number of Participants Who Require Dose Modification

Timeframe: From first dose up to 30 days after the last dose of study drug (up to 4 years)

Safety Extension Phase: Number of Participants With TEAEs Leading to Treatment Discontinuation

Timeframe: From first dose up to 30 days after the last dose of study drug (up to 4 years)

Trial details

NCT IDNCT03984097

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-25

View on ClinicalTrials.gov More Multiple Myeloma trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Must have previously untreated multiple myeloma (MM) as defined by the IMWG criteria requiring treatment according to the investigator.
✓. Are appropriate candidates for either the VRd or Rd backbone antimyeloma therapy according to the investigator.
✓. Must have measurable disease defined by at least 1 of the following:
✓. Participants receiving lenalidomide must be able to take concurrent prophylactic anticoagulation per standard clinical practice as directed by the investigator.
✓. Life expectancy \>3 months.
✓. Eastern Cooperative Oncology Group (ECOG) performance status score less than or equal to (\<=) 2.

Exclusion criteria

✕. Prior systemic therapy for MM.
✕. Current participation in another interventional study, including other clinical trials with investigational agents (including investigational vaccines or investigational medical device) within 4 weeks of the first dose of TAK-079 or any agent in the backbone regimen and throughout the duration of this trial.
✕. Prior radiation therapy within 14 days of the first dose of TAK-079 or any backbone regimen agents.
✕. Major surgery within 4 weeks before Cycle 1 Day 1 (kyphoplasty is not considered major surgery). Participants should be fully recovered from any surgically related complications.
✕