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Talquetamab for Multiple Myeloma (MonumenTAL-1 Trial)
MonumenTAL-1 Trial Summary
This trial is to study the safety of Talquetamab and to find the best dose for future trials.
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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- I have taken a lot of steroids, like prednisone, recently.Women who could become pregnant must have a negative pregnancy test before starting the study.I haven't had any live vaccines recently and won't until after the trial.Side effects from my past cancer treatments have mostly gone away.I am fully active or can carry out light work.My multiple myeloma has affected or is suspected to affect my brain or spinal cord.My multiple myeloma diagnosis follows international guidelines.My multiple myeloma is measurable and I've tried all treatments without success or couldn't tolerate them.You have high levels of specific proteins in your blood or urine that indicate multiple myeloma.I had a stem cell transplant recently and am not on immunosuppressants.My multiple myeloma has worsened despite treatment, or I couldn't tolerate the treatments.
- Group 1: Part 1: Dose Escalation (Talquetamab) - Intravenous (IV)
- Group 2: Part 2: Dose Expansion (Talquetamab)
- Group 3: Part 1: Dose Escalation (Talquetamab) - Subcutaneous (SC)
- 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
Is there any availability to join this experiment?
"Affirmative, this clinical trial is still recruiting patients. It was initially advertised on December 16th 2017 and the original post has been edited as recently as December 1st 2022."
Are there any precedent investigations concerning the effects of Talquetamab?
"Initially studied in 2017 at the Hosp. Clinico Univ. de Salamanca, talquetamab has seen 6 active studies since then; a plethora of these investigations are taking place out of Duarte, California with nary any completed trials on record."
Does this trial explore new methods of treatment?
"Since 2017, Talquetamab has become an increasingly common medical research topic. Initially studied by Janssen Research & Development LLC in a clinical trial with 260 participants, it was granted Phase 1 Drug Approval shortly afterwards. Nowadays there are 6 active studies taking place across 14 countries and 40 cities worldwide."
What is the geographic scope of this research project?
"Those interested in taking part of this clinical trial have the option to register at City of Hope, located in Duarte; Sarah Cannon Research Institute (Nashville); University of Alabama Birmingham (Birmingham) and 4 other locations."
How many individuals are being admitted to this clinical research?
"In order for the trial to be properly conducted, 260 participants who meet all of its eligibility criteria must be recruited. Janssen Research & Development, LLC is responsible for executing this study and has chosen City of Hope in Duarte, California and Sarah Cannon Research Institute in Nashville Tennessee as two locations where it will take place."
Has Talquetamab received regulatory endorsement from the FDA?
"Talquetamab was assigned a score of 1 due to the fact that it is currently being tested in Phase I trials, and so there exists limited evidence for its safety or efficacy."
What are the prospective results of this medical examination?
"According to Janssen Research & Development, LLC., the principal outcome being measured over a 28-day span is safety and tolerability as ascertained by the number of participants experiencing adverse events. As well, this trial will evaluate several secondary outcomes such as time to response (TTR), antibody formation against talquetamab, and overall response rate (ORR)."
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