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Talquetamab for Multiple Myeloma (MonumenTAL-1 Trial)
MonumenTAL-1 Trial Summary
This trial will study whether talquetamab can help treat people with multiple myeloma that has gotten worse after other treatments or that never responded to other treatments.
MonumenTAL-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMonumenTAL-1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.MonumenTAL-1 Trial Design
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Who is running the clinical trial?
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- My multiple myeloma can be measured by tests.I have not had a stroke or seizure in the last 6 months.Side effects from my past cancer treatments have mostly gone away.Women who could become pregnant need to have a negative pregnancy test before starting the study.I have been treated with CAR-T or T cell therapy.My multiple myeloma diagnosis follows international guidelines.I can take care of myself and am up and about more than half of my waking hours.I have taken a high dose of steroids recently.
- Group 1: Part 3: Cohort C (Talquetamab)
- Group 2: Part 3: Cohort B (Talquetamab)
- Group 3: Part 3: Cohort D (Talquetamab)
- Group 4: Part 3: Cohort A (Talquetamab)
- 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
How many healthcare facilities are currently conducting this research?
"Patients can join this trial at various medical centres, including the University of Alabama Birmingham in Birmingham, Arkansas for Medical Sciences in Little Rock, and Rochester Medical Center in Rochester. Additionally, there are 13 other sites that are also participating."
Are there any records of further experimentation involving Talquetamab?
"Talquetamab was first investigated in 2017 at Hosp. Clinico Univ. de Salamanca, with no completed trials to-date. Currently, 6 active studies are underway primarily located within Birmingham, Alabama."
Has Talquetamab received governmental sanction as a therapeutic option?
"While clinical data has not yet established efficacy, Talquetamab's safety is supported by prior research and thus it receives a rating of 2."
Is this experiment still open to additional participants?
"Affirmative. Clinicaltrials.gov's data confirms that this clinical trial, first posted on February 1st 2021, is actively recruiting participants. 320 patients must be recruited from 13 different healthcare institutions across the country."
What is the sample size of this clinical experiment?
"This medical trial requires 320 consenting individuals that meet the requisite criteria. Participating patients can join from various parts of the country, such as University of Alabama Birmingham in Birmingham or University of Arkansas for Medical Sciences in Little Rock."
Has this experiment been attempted previously?
"Talquetamab has been subject to clinical trials since 2017, the first of which was supported by Janssen Research & Development. After Phase 1 approval in 2017 following a study involving 260 participants, 6 current studies are taking place across 40 cities and 14 countries globally."
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