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Immunotherapy

Modakafusp Alfa for Multiple Myeloma (iinnovate-2 Trial)

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
No prior allogeneic hematopoietic stem cell transplant or solid organ transplant
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at screening
Must not have
Chronic condition requiring the use of systemic corticosteroids >10 mg/dL of prednisone or equivalent, in addition to any required corticosteroids for the treatment of MM
Known severe allergic or anaphylactic reactions to human recombinant proteins or excipients used in the modakafusp alfa formulation or to the study combination agents, the study medications, their analogs, or excipients in the various formulations of any agent per the prescribing information
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include reactions related to infusion such as fever or chills, allergic responses to components in the drug mixtures used including skin rashes or breathing difficulties, and general symptoms like fatigue. Organ inflammation could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not had a bone marrow or organ transplant.
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I am able to care for myself and perform daily activities.
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I have multiple myeloma as diagnosed by standard criteria.
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My cancer is still detectable after stem cell transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I take more than 10 mg/dL of prednisone or equivalent for a chronic condition, not including my MM treatment.
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I am not allergic to any ingredients in the medication or its similar drugs.
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My heart's electrical cycle is longer than normal.
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My multiple myeloma has spread to my brain or meninges.
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I have been diagnosed with a specific blood or bone marrow condition.
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I have been treated with modakafusp alfa before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 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
Number of Participants With Dose-limiting Toxicities (DLTs)
Secondary study objectives
Duration of Response (DOR)
Group 1: Duration of MRD Negativity Status at a Threshold of 10^-5 in Participants Achieving MRD Negativity
Group 1: Percentage of Participants with MRD Negativity Status at a Threshold of 10^-5
+11 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pomalidomide
2011
Completed Phase 2
~1060
Modakafusp alfa
2022
Completed Phase 2
~290
Lenalidomide
2005
Completed Phase 3
~2240
Bortezomib
2005
Completed Phase 3
~1410
Carfilzomib
2017
Completed Phase 3
~1430
Daratumumab
2014
Completed Phase 3
~2380

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Multiple Myeloma include monoclonal antibodies, proteasome inhibitors, and immunomodulatory drugs. Monoclonal antibodies, such as daratumumab, target specific proteins on the surface of myeloma cells, marking them for destruction by the immune system. Proteasome inhibitors, like bortezomib, block the proteasome's function, leading to the accumulation of toxic proteins within cancer cells, causing cell death. Immunomodulatory drugs, such as lenalidomide, enhance the immune system's ability to fight cancer and inhibit the growth of myeloma cells. These mechanisms are crucial as they target the cancer cells directly or enhance the body's natural defenses, offering multiple pathways to control and potentially eradicate the disease.
The importance of dose and schedule in cancer chemotherapy: epithelial ovarian cancer.Sorafenib for the treatment of multiple myeloma.

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,240 Previous Clinical Trials
4,149,456 Total Patients Enrolled
50 Trials studying Multiple Myeloma
15,384 Patients Enrolled for Multiple Myeloma
Study DirectorStudy DirectorTakeda
1,290 Previous Clinical Trials
502,497 Total Patients Enrolled
25 Trials studying Multiple Myeloma
4,681 Patients Enrolled for Multiple Myeloma

Media Library

Modakafusp alfa (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05556616 — Phase 1
Multiple Myeloma Research Study Groups: Group 1 (MM Maintenance) Arm 1: Modakafusp alfa + Lenalidomide, Group 2 (RRMM Doublets) Arm 2: Modakafusp alfa + Pomalidomide, Group 2 (RRMM Doublets) Arm 3: Modakafusp alfa + Bortezomib, Group 2 (RRMM Doublets) Arm 4: Modakafusp alfa + Carfilzomib, Group 3 (RRMM Triplets) Arm A: Modakafusp alfa + Pomalidomide + Bortezomib, Group 3 (RRMM Triplets) Arm D: Modakafusp alfa + Daratumumab + Pomalidomide
Multiple Myeloma Clinical Trial 2023: Modakafusp alfa Highlights & Side Effects. Trial Name: NCT05556616 — Phase 1
Modakafusp alfa (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05556616 — Phase 1
~5 spots leftby Dec 2025