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Monoclonal Antibodies

TAK-981 + Mezagitamab + Daratumumab + Hyaluronidase-fihj for Multiple Myeloma

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
Has failed at least 3 prior lines of anti-myeloma treatments and is either refractory, or intolerant to at least 1 immunomodulatory drug (IMiD), at least 1 proteasome inhibitor, and refractory to at least 1 anti-CD38 antibody and who have demonstrated disease progression with the last therapy
Has undergone stem cell transplant or is considered transplant ineligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial is testing TAK-981, a potential new cancer treatment, in combination with existing anti-CD38 monoclonal antibodies (mAbs) for people with multiple myeloma that has returned or does not respond to treatment. The goal is to see if the combination is safe and effective, and to find the best dose.

Eligible Conditions
  • Relapsed or Refractory Multiple Myeloma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have tried at least three different treatments for myeloma and your disease has not responded well to at least one immunomodulatory drug, one proteasome inhibitor, and one anti-CD38 antibody.
Select...
You have had a stem cell transplant, or you cannot have a stem cell transplant.
Select...
You have recovered from any side effects of previous treatment, or the side effects are known to be permanent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs)
Phase 1b: Number of Participants with Treatment Emergent Adverse Events (TEAEs), By Severity at Each Dose Level
Phase 2: Overall Response Rate (ORR) (Response of Atleast Partial Response [PR]) as Assessed by the Investigator's Based on International Myeloma Working Group (IMWG) Criteria
Secondary outcome measures
AUCt: Area Under the Plasma Concentration-time Curve from Time 0 to Time t Over the Dosing Interval for TAK-981
AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-981
CL: Total Clearance After Intravenous Administration for TAK-981
+18 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase 2 - Dose Expansion: TAK-981 + Daratumumab and Hyaluronidase-fihj or MezagitamabExperimental Treatment3 Interventions
TAK-981 at RP2D as determined in Phase 1b. Mezagitamab at a fixed dose of 600 mg SC injection or Daratumumab and Hyaluronidase-fihj at a fixed dose of 1800 mg weekly in Cycles 1 and 2 (each cycle is of 28 days), followed by every 2 weeks in Cycle 3 through 6, followed by every 4 weeks up to Cycle 24 or until disease progression unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
Group II: Phase 1b, Part 2 - Lead-in Cohort: TAK-981 + Daratumumab and Hyaluronidase-fihjExperimental Treatment2 Interventions
Daratumumab and hyaluronidase-fihj: 1800 mg SC injection QW once weekly in Cycles 1 and 2 , (each cycle is of 28 days) followed by every 2 weeks in Cycle 3 through 6 , followed by every 4 weeks up to Cycle 24 until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. TAK-981: As per dose and schedule of TAK-981 defined in Phase 1b Part 1.
Group III: Phase 1b, Part 1 - Dose Escalation: Arm B - TAK-981 Weekly (QW) + MezagitamabExperimental Treatment2 Interventions
Mezagitamab: A fixed dose of 600 mg SC injection once weekly in Cycles 1 and 2 (each cycle is of 28 days), followed by once every 2 weeks from Cycle 3 through 6, then every 4 weeks up to Cycle 24 or until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. TAK-981: Escalating doses of TAK-981 QW IV infusion on Days 1, 8, 15, and 22 in Cycles 1 and 2 (each cycle is of 28 days), followed by every 2 weeks in Cycles 3 through 6, followed by once every 4 weeks. up to Cycle 24 or until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
Group IV: Phase 1b, Part 1 - Dose Escalation: Arm A - TAK-981 Twice Weekly (BIW) + MezagitamabExperimental Treatment2 Interventions
Mezagitamab: A fixed dose of 600 mg subcutaneous (SC) injection once weekly in Cycles 1 and 2 (each cycle is of 28 days), followed by once every 2 weeks in Cycle 3 through 6, then every 4 weeks up to Cycle 24 or until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. TAK-981: Escalating doses of TAK-981 BIW intravenous (IV) infusion on Days 1, 4, 8, 11 and 15 in Cycle 1 and 2 (each Cycle is of 28 days) followed by every 2 weeks in Cycles 3 through 6, followed by once every 4 weeks up to Cycle 24 or until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mezagitamab
2018
Completed Phase 2
~50
TAK-981
2020
Completed Early Phase 1
~20

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,198 Previous Clinical Trials
4,178,326 Total Patients Enrolled
50 Trials studying Multiple Myeloma
18,226 Patients Enrolled for Multiple Myeloma
Medical DirectorStudy DirectorTakeda
2,769 Previous Clinical Trials
8,062,173 Total Patients Enrolled
25 Trials studying Multiple Myeloma
6,971 Patients Enrolled for Multiple Myeloma
Study DirectorStudy DirectorTakeda
1,202 Previous Clinical Trials
489,605 Total Patients Enrolled
25 Trials studying Multiple Myeloma
7,503 Patients Enrolled for Multiple Myeloma

Media Library

Daratumumab and Hyaluronidase-fihj (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04776018 — Phase 1 & 2
Multiple Myeloma Research Study Groups: Phase 1b, Part 1 - Dose Escalation: Arm B - TAK-981 Weekly (QW) + Mezagitamab, Phase 1b, Part 2 - Lead-in Cohort: TAK-981 + Daratumumab and Hyaluronidase-fihj, Phase 1b, Part 1 - Dose Escalation: Arm A - TAK-981 Twice Weekly (BIW) + Mezagitamab, Phase 2 - Dose Expansion: TAK-981 + Daratumumab and Hyaluronidase-fihj or Mezagitamab
Multiple Myeloma Clinical Trial 2023: Daratumumab and Hyaluronidase-fihj Highlights & Side Effects. Trial Name: NCT04776018 — Phase 1 & 2
Daratumumab and Hyaluronidase-fihj (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04776018 — 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 medical condition is TAK-981 most often used to treat?

"TAK-981 is the most common treatment for cell transplants. However, it can also be used to help with other conditions like immunomodulation, increased absorption and dispersion of other drugs, and urography."

Answered by AI

What is the clinical evidence for TAK-981?

"TAK-981 was first researched at Mayo Clinic in 2012 and, as of now, 55 trials have completed. Out of the 152 active trials, a significant portion are being conducted in Winston-Salem, North carolina."

Answered by AI

How many individuals are included in the total sample size for this research?

"That is accurate. The information available on clinicaltrials.gov says that this study is looking for patients right now. The trial was first posted on 4/20/2021 and was last updated on 1/6/2022. In total, they need 81 people to enroll at 15 different hospitals or clinics."

Answered by AI

Are numerous hospitals in the city participating in this experiment?

"There are 18 enrolment sites for this study, including Wake Forest University School of Medicine - PPDS in Winston-Salem, North carolina, University of California at Davis in Sacramento, California, and Indiana University in Indianapolis, Indiana."

Answered by AI
~7 spots leftby Mar 2025