Modakafusp Alfa for Multiple Myeloma

(iinnovate-2 Trial)

Recruiting at 68 trial locations

Overseen By Takeda Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Takeda

Must be taking: Lenalidomide

Must not be taking: Strong CYP3A4 inducers

Disqualifiers: Other MM studies, Primary amyloidosis, CNS involvement, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years for Group 1, up to 5 years for Groups 2 and 3

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called modakafusp alfa, given with other medications, to treat patients with multiple myeloma. The goal is to find the safest and most effective dose. The study focuses on patients who need ongoing treatment or have not responded to previous treatments.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids greater than 10 mg/dL of prednisone or equivalent, you may not be eligible to participate.

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

Adults with Multiple Myeloma who've had a stem cell transplant within the past 12 months and are MRD positive post-transplant. They should have good organ function, an ECOG status of 0-2, and no progression after initial therapy. Excluded are those in other MM trials, treated with modakafusp alfa before, or with certain medical conditions like severe allergies to trial drugs or active hepatitis B/C or HIV.

Inclusion Criteria

My organ functions are within the required range for the study.

I had a stem cell transplant for multiple myeloma within the last 6 months.

I have not had a bone marrow or organ transplant.

Exclusion Criteria

My heart's electrical cycle is longer than normal.

My multiple myeloma has spread to my brain or meninges.

I haven't had cancer, except for specific low-risk types, in the last 3 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive modakafusp alfa in combination with other drugs based on their assigned group until disease progression, unacceptable toxicity, or other discontinuation criteria are met.

Up to 2 years for Group 1, up to 5 years for Groups 2 and 3

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Treatment Details

Interventions

• Modakafusp alfa

Trial Overview The study is testing modakafusp alfa combined with other myeloma treatments (Carfilzomib, Lenalidomide etc.) to find the highest safe dose. Participants will receive increasing doses of modakafusp alfa through IV until they reach a dose that's effective without harmful side effects.

Participant Groups

Group I: Group 3 (RRMM Triplets) Arm D: Modakafusp alfa + Daratumumab + Pomalidomide Experimental Treatment 3 Interventions

Modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with Daratumumab injection subcutaneously on Days 1, 8, 15 and 22 of Cycles 1 and 2, further followed by on Days 1 and 15 of Cycles 3 to 6, thereafter on Day 1 on a 28-day (4-week) treatment cycle along with Pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.

Group II: Group 3 (RRMM Triplets) Arm A: Modakafusp alfa + Pomalidomide + Bortezomib Experimental Treatment 3 Interventions

Modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with Pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle along with Bortezomib injection subcutaneously on Days 8, 15 and 22 for the first 8 cycles and subsequently on Days 8 and 22 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.

Group III: Group 2 (RRMM Doublets) Arm 4: Modakafusp alfa + Carfilzomib Experimental Treatment 2 Interventions

Modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with Carfilzomib IV, on Day 1, 8 and 15 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. This arm is closed for enrollment after 3 participants were enrolled.

Group IV: Group 2 (RRMM Doublets) Arm 3: Modakafusp alfa + Bortezomib Experimental Treatment 2 Interventions

Modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with Bortezomib injection subcutaneously on Days 8, 15, and 22 for the first 8 cycles and subsequently on Days 8 and 22 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.

Group V: Group 2 (RRMM Doublets) Arm 2: Modakafusp alfa + Pomalidomide Experimental Treatment 2 Interventions

Modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with Pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.

Group VI: Group 1 (MM Maintenance) Arm 1: Modakafusp alfa + Lenalidomide Experimental Treatment 2 Interventions

Modakafusp alfa, infusion intravenously (IV), once on Day 1, once every 4 weeks (Q4W), in combination with Lenalidomide capsules orally once daily continuously on Days 1 to 28, in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or to a maximum of 2 years for MRD \[-\] negative participants, whichever occurs first. Participants who remain MRD positive with demonstrated clinical benefit after 2 years of maintenance therapy may continue treatment beyond 2 years with agreement of the sponsor/designee.

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