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TAK-981 + Mezagitamab + Daratumumab + Hyaluronidase-fihj for Multiple Myeloma
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.
- Relapsed or Refractory Multiple Myeloma
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have had HIV, hepatitis B, or hepatitis C in the past.You have a widespread infection that needs antibiotics to treat.You are taking certain medications that affect the way your body processes other drugs.You have certain blood-related conditions like primary amyloidosis or smoldering multiple myeloma.The only way to measure the disease is through the presence of plasmacytoma.You have had another type of cancer within the past 3 years, except for certain specific types that have been treated or are not actively being treated.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.You have been treated with more than one type of anti-CD38 antibody beforeYou are taking medications that can affect your heart's electrical activity during Phase 1b of the trial.You have a history of having a certain heart rhythm measurement (QTcF) that is too long.You have had heart problems that were not stable in the past 6 months.You must have a specific type of multiple myeloma with measurable signs of the disease.You have had a stem cell transplant, or you cannot have a stem cell transplant.You currently have or have had a lung inflammation called pneumonitis.You have had a procedure called plasmapheresis in the last 28 days.You have recovered from any side effects of previous treatment, or the side effects are known to be permanent.
- Group 1: Phase 1b, Part 1 - Dose Escalation: Arm B - TAK-981 Weekly (QW) + Mezagitamab
- Group 2: Phase 1b, Part 2 - Lead-in Cohort: TAK-981 + Daratumumab and Hyaluronidase-fihj
- Group 3: Phase 1b, Part 1 - Dose Escalation: Arm A - TAK-981 Twice Weekly (BIW) + Mezagitamab
- Group 4: Phase 2 - Dose Expansion: TAK-981 + Daratumumab and Hyaluronidase-fihj or Mezagitamab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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