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Number of Visits: Unknown

Duration: Up to 2 years

50 Participants Needed

TAK-079 for Multiple Myeloma

Recruiting at 8 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Takeda

Must be taking: Antimyeloma therapy

Must not be taking: Investigational agents

Disqualifiers: HIV, Hepatitis B/C, Amyloidosis, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently in another interventional study or have had certain treatments like radiation therapy or major surgery recently.

How does the drug TAK-079 differ from other treatments for multiple myeloma?

TAK-079 is unique because it targets the TAK1 protein, which plays a key role in the survival and drug resistance of multiple myeloma cells. By inhibiting TAK1, this drug not only aims to kill cancer cells but also helps prevent bone destruction, offering a dual benefit for patients.¹ ² ³ ⁴ ⁵

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

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.

Inclusion Criteria

I can take blood thinners while on lenalidomide as advised.

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

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

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Exclusion Criteria

Your heart's electrical activity, as shown on a test called an ECG, should not have a specific measurement (QTcF) higher than 470 milliseconds. If the machine shows a higher value, a qualified person should double-check it on another test.

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

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

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TAK-079 in combination with LenDex or VRd. TAK-079 is administered subcutaneously once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter.

Up to 2 years

Safety Extension

Participants who have previously received and tolerated TAK-079-based parent study will continue to the extension study to evaluate the long-term safety profile of TAK-079.

Up to 4 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

TAK-079

Trial Overview 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.

Participant Groups

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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Findings from Research

Monoclonal antibodies like daratumumab and elotuzumab, especially when combined with other treatments, have shown high response rates and improved survival in patients with relapsed and refractory multiple myeloma, highlighting their efficacy in targeting specific plasma cell proteins.

CAR T cell therapy, particularly targeting B-cell maturation antigen (BCMA), has demonstrated dramatic remissions in patients with difficult-to-treat multiple myeloma, although it can lead to significant side effects like cytokine release syndrome and neurotoxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hematologic Malignancies: Plasma Cell Disorders.Dhodapkar, MV., Borrello, I., Cohen, AD., et al.[2019]