Modakafusp Alfa for Multiple Myeloma
(iinnovate-2 Trial)

Recruiting in Palo Alto (17 mi)

+68 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Takeda

No Placebo Group

Breakthrough Therapy

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.

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.

See 7 more

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.

See 7 more

Treatment Details

Interventions

Modakafusp alfa (Immunotherapy)

Trial OverviewThe 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

6Treatment groups

Experimental Treatment

Group I: Group 3 (RRMM Triplets) Arm D: Modakafusp alfa + Daratumumab + PomalidomideExperimental Treatment3 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 + BortezomibExperimental Treatment3 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 + CarfilzomibExperimental Treatment2 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 + BortezomibExperimental Treatment2 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 + PomalidomideExperimental Treatment2 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 + LenalidomideExperimental Treatment2 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.