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CAR T-cell Therapy

Modakafusp Alfa for Multiple Myeloma (iinnovate-1 Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Millennium Pharmaceuticals, Inc.

Eligibility Criteria Checklist

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

Must have

For Parts 1 and 2: Has previously received at least 3 lines of myeloma therapy (for example, containing an Immunomodulatory imide drug [IMiD], a proteasome inhibitor [PI], an alkylating agent, and/or an anti-CD38 as single agents or in combination)

For Parts 1 and 2: Is either refractory to or intolerant of at least 1 PI and at least 1 IMiD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 90 months

Awards & highlights

iinnovate-1 Trial Summary

This trial will test the safety and efficacy of modakafusp alfa in people with relapsed or refractory multiple myeloma.

Who is the study for?

This trial is for adults with relapsed/refractory Multiple Myeloma who've had at least 3 prior treatments, including an IMiD and a PI. They must show disease progression needing further therapy and have measurable disease markers. Exclusions include hepatitis B or C infection, central nervous system MM involvement, certain other cancers within the last 3 years, or recent stem cell transplants.Check my eligibility

What is being tested?

The study tests Modakafusp alfa's safety and optimal dosing alone or with Dexamethasone in three parts: finding a safe dose without harmful side effects; assessing its effectiveness alone or with standard-dose Dexamethasone; determining the best dose considering risks and benefits. It's administered intravenously at two different doses.See study design

What are the potential side effects?

Potential side effects of Modakafusp alfa may include reactions related to infusion into the vein, immune system complications affecting various organs, fatigue, blood disorders like anemia or clotting issues, as well as increased susceptibility to infections.

iinnovate-1 Trial Eligibility Criteria

Inclusion Criteria

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

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I have had at least 3 different treatments for myeloma.

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I have not responded to or cannot tolerate at least one proteasome inhibitor and one immunomodulatory drug.

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My condition worsened despite treatments with specific cancer drugs.

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I have undergone at least 3 different treatments for myeloma.

iinnovate-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 90 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 90 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 90 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1: Percentage of Participants Reporting one or More Grade 3 TEAEs

Part 1: Percentage of Participants Reporting one or More Serious Adverse Events (SAEs)

Part 1: Percentage of Participants Reporting one or More Treatment Emergent Adverse Events (TEAEs)

+9 more

Secondary outcome measures

Part 1 and 2: Percentage of Participants With Dose-limiting Toxicities (DLTs)- Like Events

Part 1: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp alfa

Part 1: AUC∞: Area Under the Serum Concentration-time Curve from Time 0 to Infinity for Modakafusp alfa

+38 more

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915

Deep Vein Thrombosis

Cerebrospinal fluid leak

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Ondansetron

Aprepitant

iinnovate-1 Trial Design

7Treatment groups

Experimental Treatment

Group I: Part 3 (Dose Extension): Modakafusp alfa 240 mgExperimental Treatment1 Intervention

Participants will receive modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.

Group II: Part 3 (Dose Extension): Modakafusp alfa 120 mgExperimental Treatment1 Intervention

Participants will receive modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.

Group III: Part 2 (Dose Expansion): Modakafusp alfa TBD + Dexamethasone 40 mgExperimental Treatment2 Interventions

Dose(s) for Phase 2 will be based on safety and tolerability results from the preceding Phase 1 dose escalation cohorts. Participants in Phase 2 cohorts will receive modakafusp alfa TBD as a single agent. Participants in at least 1 cohort will receive modakafusp alfa TBD and modakafusp alfa TBD and dexamethasone 40 mg, orally, once weekly of each 28-day treatment cycle until treatment discontinuation.

Group IV: Part 1 (Dose Escalation) Schedule D: Modakafusp alfa TBDExperimental Treatment1 Intervention

Modakafusp alfa TBD, infusion, IV, once every 4 weeks (Q4W) on Day 1 of each 28-day treatment cycle until treatment discontinuation. The starting dose will be decided by the investigators and sponsor representatives based on all available clinical information.

Group V: Part 1 (Dose Escalation) Schedule C: Modakafusp alfa TBDExperimental Treatment1 Intervention

Modakafusp alfa TBD, infusion, IV, once every 3 weeks (Q3W) on Day 1 of each 21-day treatment cycle until treatment discontinuation. The starting dose will be decided by the investigators and sponsor representatives based on all available clinical information.

Group VI: Part 1 (Dose Escalation) Schedule B: Modakafusp alfa TBDExperimental Treatment1 Intervention

Modakafusp alfa TBD, infusion, IV, once every 2 weeks (Q2W) on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation. The starting dose will be decided by the investigators and sponsor representatives based on all available clinical information.

Group VII: Part 1 (Dose Escalation) Schedule A: Modakafusp alfa 0.001 Up to 14 mg/kgExperimental Treatment1 Intervention

Modakafusp alfa 0.001 up to 14 milligram per kilogram (mg/kg), infusion, intravenously (IV), once every week (Q1W) on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2590

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Millennium Pharmaceuticals, Inc.Lead Sponsor

404 Previous Clinical Trials

46,578 Total Patients Enrolled

82 Trials studying Multiple Myeloma

9,726 Patients Enrolled for Multiple Myeloma

TakedaLead Sponsor

1,202 Previous Clinical Trials

4,177,926 Total Patients Enrolled

50 Trials studying Multiple Myeloma

17,897 Patients Enrolled for Multiple Myeloma

Medical Director Clinical ScienceStudy DirectorMillennium Pharmaceuticals, Inc.

197 Previous Clinical Trials

62,911 Total Patients Enrolled

8 Trials studying Multiple Myeloma

2,352 Patients Enrolled for Multiple Myeloma

Media Library

Modakafusp alfa (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03215030 — Phase 1 & 2

Multiple Myeloma Research Study Groups: Part 1 (Dose Escalation) Schedule C: Modakafusp alfa TBD, Part 1 (Dose Escalation) Schedule B: Modakafusp alfa TBD, Part 1 (Dose Escalation) Schedule A: Modakafusp alfa 0.001 Up to 14 mg/kg, Part 2 (Dose Expansion): Modakafusp alfa TBD + Dexamethasone 40 mg, Part 1 (Dose Escalation) Schedule D: Modakafusp alfa TBD, Part 3 (Dose Extension): Modakafusp alfa 120 mg, Part 3 (Dose Extension): Modakafusp alfa 240 mg

Multiple Myeloma Clinical Trial 2023: Modakafusp alfa Highlights & Side Effects. Trial Name: NCT03215030 — Phase 1 & 2

Modakafusp alfa (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03215030 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other investigations have been conducted for the evaluation of TAK-573?

"Presently, there are 553 active clinical trials testing the effects of TAK-573 with 144 in their final phase. These studies span 18625 different locations, however a majority are held within Mishawaka, Indiana."

Answered by AI

Are there any remaining slots available for this experiment?

"The clinical trial, first published on October 4th 2017 is currently enrolling participants according to information hosted by clinicialtrials.gov. The listing was last amended on November 10th 2022."

Answered by AI

In how many facilities is this experiment being conducted?

"This medical trial is enrolling patients at multiple locations including Baptist Cancer Center - Memphis - Walnut Grove in Memphis, Tennessee; Swedish Medical Center in Seattle, Washington; and Duke University Medical Center in Durham, North carolina amongst 36 other sites."

Answered by AI

For how many participants is this clinical trial recruiting?

"Researchers need to recruit 336 eligible patients for the trial, who can partake from various sites such as Baptist Cancer Center - Memphis - Walnut Grove in Tennessee and Swedish Medical Center in Washington."

Answered by AI

In what ways is TAK-573 typically employed by clinicians?

"Physicians often turn to TAK-573 for treating ophthalmia, sympathetic. Additionally, this pharmaceutical agent can be applied in the management of eye branch retinal vein occlusion and macular edema."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma

2017. "A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03215030.

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