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Monoclonal Antibodies

Talquetamab for Multiple Myeloma (MonumenTAL-1 Trial)

Phase 1
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2.10 years
Awards & highlights

MonumenTAL-1 Trial Summary

This trial is to study the safety of Talquetamab and to find the best dose for future trials.

Who is the study for?
This trial is for adults with multiple myeloma that's gotten worse after standard treatments or who couldn't handle those treatments. They must understand the study and agree to participate, have a good performance status (able to carry out daily activities), and meet specific disease measurement criteria. Women able to have children need a negative pregnancy test.Check my eligibility
What is being tested?
The trial is testing Talquetamab, aiming to find the safest dose for Phase 2 trials. It has two parts: first, increasing doses to find what's safe (Dose Escalation), then giving this safe dose to more people (Dose Expansion) to confirm its safety.See study design
What are the potential side effects?
Specific side effects of Talquetamab aren't listed here, but generally in such trials patients may experience immune reactions, fatigue, nausea, or other drug-related issues which will be closely monitored throughout the study.

MonumenTAL-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My multiple myeloma diagnosis follows international guidelines.
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My multiple myeloma is measurable and I've tried all treatments without success or couldn't tolerate them.
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My multiple myeloma has worsened despite treatment, or I couldn't tolerate the treatments.

MonumenTAL-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2.10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2.10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Part 1: Dose-limiting Toxicity (DLT)
Secondary outcome measures
Part 1 and Part 2: Biomarker Assessment
Part 1: Number of Participants with Talquetamab Antibodies
Part 1: Talquetamab Serum Concentrations
+5 more

MonumenTAL-1 Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 2: Dose Expansion (Talquetamab)Experimental Treatment1 Intervention
Participants will receive IV infusion or SC injection of Talquetamab at each putative recommended Phase 2 dose(s) (RP2D[s]) as determined in Part 1.
Group II: Part 1: Dose Escalation (Talquetamab) - Subcutaneous (SC)Experimental Treatment1 Intervention
Participants will receive Talquetamab SC. The dose levels will be selected to identify safe and tolerable putative RP2D(s).
Group III: Part 1: Dose Escalation (Talquetamab) - Intravenous (IV)Experimental Treatment1 Intervention
Participants will receive IV infusion of Talquetamab at minimum anticipated biologic effect level (MABEL)-based starting dose until the completion of the end of treatment visit. Subsequent dose levels will be selected based on the review of all available data including, but not limited to, pharmacokinetic, pharmacodynamic, safety, and preliminary antitumor activity data.

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
974 Previous Clinical Trials
6,383,966 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,585 Total Patients Enrolled

Media Library

Talquetamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03399799 — Phase 1
Blood Cancers Research Study Groups: Part 1: Dose Escalation (Talquetamab) - Intravenous (IV), Part 2: Dose Expansion (Talquetamab), Part 1: Dose Escalation (Talquetamab) - Subcutaneous (SC)
Blood Cancers Clinical Trial 2023: Talquetamab Highlights & Side Effects. Trial Name: NCT03399799 — Phase 1
Talquetamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03399799 — Phase 1

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI
~44 spots leftby Mar 2025