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TAK-079 for Multiple Myeloma

Phase 1

Waitlist Available

Research Sponsored by Takeda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have previously untreated multiple myeloma (MM) as defined by the IMWG criteria requiring treatment according to the investigator

Eastern Cooperative Oncology Group (ECOG) performance status score less than or equal to (<=) 2

Must not have

Plasmapheresis within 28 days of randomization

Known severe allergic or anaphylactic reactions to human recombinant proteins or excipients used in the TAK-079 formulation or agents in the backbone regimen (lenalidomide, bortezomib, dexamethasone) as per the respective prescribing information or for TAK-079, as outlined in the current investigator's brochure (IB)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Approved for 60 Other Conditions

No Placebo-Only Group

Summary

This trial is testing a new drug, TAK-079, for people with multiple myeloma who have already tried other treatments. The goal is to find the best dose of the new drug to give people, and to see how well it works and how safe it is.

Who is the study for?

This trial is for adults with newly diagnosed Multiple Myeloma who have measurable disease, can take blood clot prevention meds if on lenalidomide, and have a life expectancy over 3 months. They must not have had prior MM therapy (except certain cases), recent major surgery or radiation, other clinical trials within 4 weeks, severe allergies to study drugs, active infections or certain other cancers.

What is being tested?

The trial tests the safety and optimal dose of TAK-079 combined with standard myeloma treatments like Lenalidomide and Dexamethasone. It also offers continued access to TAK-079 for those previously in related studies and assesses long-term safety.

What are the potential side effects?

Possible side effects include allergic reactions to the drug components, potential impact on organ function due to the disease's nature or treatment complications. Specific side effects of TAK-079 are not listed but may be similar to those of immunotherapies such as fatigue or infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have multiple myeloma needing treatment, as per IMWG criteria, and haven't been treated yet.

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I can take care of myself but might not be able to do heavy physical work.

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I was previously treated with TAK-079 in a Takeda study and the study is closed or about to close.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had plasmapheresis in the last 28 days.

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I am not allergic to the medication TAK-079 or its components.

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I have been diagnosed with a specific blood or bone marrow condition.

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I haven't needed strong antibiotics for a serious infection in the last 14 days.

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My multiple myeloma shows signs of affecting the lining of my brain.

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I am not currently in another study or haven't been in one for the last 4 weeks.

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I have not had major surgery in the last 4 weeks and have recovered from any surgery-related issues.

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I was disqualified from the main study due to not meeting its treatment criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Treatment Phase: RP2D of TAK-079

Secondary study objectives

Treatment Phase: Number of Participants With Grade 3 or Higher TEAEs

Treatment Phase: Overall Response Rate (ORR)

Side effects data

From 2022 Phase 2 trial • 36 Patients • NCT04159805

17%

Pyrexia

Depression

Diplopia

Suicidal ideation

Atrioventricular block first degree

Malaise

Conjunctivitis allergic

Dysarthria

Dyspnoea exertional

Fatigue

Injection site pain

Muscular weakness

Paraesthesia

Influenza like illness

Lymphocyte count decreased

Myasthenia gravis

Parosmia

Periorbital oedema

Visual impairment

100%

80%

60%

40%

20%

Study treatment Arm

TAK-079 Placebo-matching

TAK-079 300 mg

TAK-079 600 mg

Awards & Highlights

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Treatment Phase: TAK-079 and VRdExperimental Treatment5 Interventions

TAK-079 subcutaneously, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter, along with bortezomib, subcutaneously, once on Days 1, 8, and 15, for a maximum of 8 cycles, lenalidomide, orally, once daily for 21 days, and dexamethasone, orally or intravenously, once on Days 1, 8, 15 and 22 in each 28-day treatment until PD or unacceptable toxicity, withdrawal of consent, death, or termination of the study by sponsor for up to 2 years. The dosage of dexamethasone can be reduced for participants who are \>75 years, have poorly controlled diabetes, or had prior intolerance to or AE from corticosteroid therapy.

Group II: Treatment Phase: TAK-079 and LenDexExperimental Treatment4 Interventions

TAK-079, subcutaneously, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter, along with lenalidomide, orally, once daily for 21 days and dexamethasone, orally or intravenously, once on Days 1, 8, 15 and 22 in each 28-day treatment until progressive disease (PD) or unacceptable toxicity, withdrawal of consent, death, or termination of the study by sponsor for up to 2 years. The dosage of dexamethasone can be reduced for participants who are greater than (\>) 75 years, have poorly controlled diabetes, or had prior intolerance to or AE from corticosteroid therapy.

Group III: Safety Extension Phase: TAK-079 and, if applicable, backbone therapy (LenDex, VRd, or PomDex)Experimental Treatment5 Interventions

TAK-079 dosing and, if applicable, backbone therapy will be administered as per the schedule outlined in the parent study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

FDA approved

Mezagitamab

Not yet FDA approved

Dexamethasone

FDA approved