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Immunotherapy

Modakafusp Alfa + Daratumumab for Multiple Myeloma (iinnovate-3 Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Takeda

Eligibility Criteria Checklist

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

Must have

For participants in the Phase 1 Dose Escalation only: Must have received at least 3 prior lines of therapy, including at least 1 proteasome inhibitor (PI), 1 immunomodulatory imide drug (IMiD), and 1 anti-CD38 monoclonal antibody (mAb) drug; or who are triple refractory to a PI, an IMiD, and an anti-CD38 mAb drug, regardless of the number of prior line(s) or therapy

Documented multiple myeloma (MM) diagnosis per IMWG criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 months

Awards & highlights

iinnovate-3 Trial Summary

This trial will study the safety and effectiveness of a new drug given with an existing drug to find the best dose for treating cancer.

Who is the study for?

Adults with relapsed or refractory multiple myeloma who have tried at least three prior therapies, including specific inhibitors and antibodies, can join this trial. They must show disease progression after the last treatment but had some positive response to previous therapy. Good physical condition is required (ECOG 0-2), and they should not have severe heart issues, certain viral infections, or require high-dose steroids.Check my eligibility

What is being tested?

The study tests Modakafusp Alfa combined with Daratumumab in adults with multiple myeloma to find a safe dosage and understand Modakafusp Alfa's properties. The trial has two phases: one for determining the best dose and another for further evaluation of that dose.See study design

What are the potential side effects?

While the specific side effects are not listed here, generally such treatments may cause immune reactions, infusion-related symptoms like fever or chills, fatigue, bone marrow suppression leading to low blood counts which increases infection risk.

iinnovate-3 Trial Eligibility Criteria

Inclusion Criteria

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

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I've had at least 3 treatments including a PI, an IMiD, and an anti-CD38 drug, or my condition didn't improve with these treatments.

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I have been diagnosed with multiple myeloma.

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My blood or urine tests show signs of disease.

iinnovate-3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 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

Therapeutic procedure

Phase 1: Number of Participants with Dose Limiting Toxicities (DLT)

Phase 2a: Overall Response Rate (ORR)

Secondary outcome measures

Phase 1 and Phase 2a: Duration of Measurable [Minimal] Residual Disease (MRD) Negativity

Phase 1 and Phase 2a: Duration of Response (DOR)

Phase 1 and Phase 2a: Number of Participants With Anti-drug Antibodies

+27 more

iinnovate-3 Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase 2a Dose Finding: Modakafusp Alfa (DL2) + DaratumumabExperimental Treatment2 Interventions

Modakafusp alfa at dose level 2 (DL2) [selected from Phase 1 Dose Escalation] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.

Group II: Phase 2a Dose Finding: Modakafusp Alfa (DL1) + DaratumumabExperimental Treatment2 Interventions

Modakafusp alfa at dose level 1 (DL1) [selected from Phase 1 Dose Escalation] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.

Group III: Phase 1 Dose EscalationExperimental Treatment2 Interventions

Modakafusp alfa 60 to 240 mg, infusion, intravenously, once every 4 weeks (Q4W) with daratumumab 1800 mg, subcutaneously (SC), once weekly (QW) in Cycles 1 and 2, twice weekly (Q2W) in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daratumumab

2014

Completed Phase 3

~1860

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor

1,202 Previous Clinical Trials

4,178,204 Total Patients Enrolled

50 Trials studying Multiple Myeloma

18,175 Patients Enrolled for Multiple Myeloma

Study DirectorStudy DirectorTakeda

1,207 Previous Clinical Trials

489,622 Total Patients Enrolled

25 Trials studying Multiple Myeloma

7,472 Patients Enrolled for Multiple Myeloma

Media Library

Daratumumab (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05590377 — Phase 1 & 2

Multiple Myeloma Research Study Groups: Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab, Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab, Phase 1 Dose Escalation

Multiple Myeloma Clinical Trial 2023: Daratumumab Highlights & Side Effects. Trial Name: NCT05590377 — Phase 1 & 2

Daratumumab (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05590377 — Phase 1 & 2

Frequently Asked Questions

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

Are there current openings for this clinical trial?

"As confirmed by clinicaltrials.gov, this experiment has been actively recruiting since its publication on the 3rd of January 2023 with last edit occuring on December 23 2022."

Answered by AI

What is the total sample size of this clinical research?

"To move forward with this medical trial, 58 patients need to be enrolled that meet the predetermined inclusion criteria. Potential participants can register from Cedars-Sinai Medical Center in Los Angeles or James R Berenson, MD Inc. located in West Hollywood."

Answered by AI

In what number of health care facilities is this experiment currently being conducted?

"This trial is enrolling patients in Cedars-Sinai Medical Center, James R Berenson MD Inc., and Fort Wayne Medical Oncology & Hematology Inc. as well as 17 additional sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Modakafusp Alfa Together With Daratumumab Adults With Relapsed or Refractory Multiple Myeloma

2023. "A Study of Modakafusp Alfa Together With Daratumumab Adults With Relapsed or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05590377.