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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years

Sex

ALL

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.