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Monoclonal Antibodies

Teclistamab for Multiple Myeloma

Phase 2
Recruiting
Research Sponsored by SCRI Development Innovations, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has documented diagnosis of MM according to the IMWG diagnostic criteria (Rajkumar 2011)
Has an ECOG performance status (Oken 1982) of 0 to 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months of teclistamab treatment
Awards & highlights

Study Summary

This trial tests a new drug to treat multiple myeloma, a type of cancer.

Who is the study for?
Adults over 18 with Multiple Myeloma who've had at least four prior treatments, including specific therapies (PI, IMiD, CD38 antibody), can join. They must be in good health otherwise, not pregnant or planning to become so, and agree to use contraception. Participants need a body weight over 35 kg and must stay close to the trial site for monitoring after initial doses.Check my eligibility
What is being tested?
The study is testing Teclistamab given as an outpatient treatment for Multiple Myeloma patients. It's a phase II trial which means they're looking at how effective this drug is and what side effects it has when administered outside of a hospital setting.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system like inflammation in different parts of the body (CRS), changes in mental status (ICANS), infections, bleeding due to coagulopathy issues, heart problems such as arrhythmias or heart failure, and lung issues like reduced airflow.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with multiple myeloma.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am informed about the side effects of teclistamab and have someone to watch over me.
Select...
I have had 4 or more treatments for my multiple myeloma, including specific types of therapy.
Select...
My body weight is over 35 kg.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months of teclistamab treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months of teclistamab treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of CRS of any grade during the first two cycles
Secondary outcome measures
Duration of response (DOR)
Healthcare resource utilization in the outpatient setting
Incidence of All grade and Grade ≥3 ICANS
+17 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Teclistamab and TocilizumabExperimental Treatment2 Interventions
Participants will receive the recommended dosage of Teclistamab according to the TECVAYLI™ USPI (step-up dosing followed by weekly treatment dosing).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tocilizumab
2012
Completed Phase 4
~1840

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCIndustry Sponsor
976 Previous Clinical Trials
6,384,642 Total Patients Enrolled
70 Trials studying Multiple Myeloma
19,412 Patients Enrolled for Multiple Myeloma
SCRI Development Innovations, LLCLead Sponsor
191 Previous Clinical Trials
13,513 Total Patients Enrolled
9 Trials studying Multiple Myeloma
321 Patients Enrolled for Multiple Myeloma
Robert Rifkin, MDStudy ChairSCRI Development Innovations, LLC

Frequently Asked Questions

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

Is it feasible for interested parties to join this trial at present?

"According to information hosted on clinicaltrials.gov, the medical trial is currently in search of volunteers and has been since 9/30/2023, with its most recent update occurring on 9/6/2023."

Answered by AI

How have Teclistamab and Tocilizumab been demonstrated to be hazard-free for patients?

"The risk associated with Teclistamab and Tocilizumab, due to the Phase 2 trial status, is estimated at a score of 2. This signifies that there are some safety data available but no efficacy trials conducted yet."

Answered by AI

What is the scope of involvement in this research experiment?

"Janssen Research & Development, LLC are the sponsors of this trial and require 50 suitable participants to initiate. The study will be facilitated from Oncology Associates of Oregon in Eugene, Oregon and Virginia Oncology Associates located in Norfolk, Virginia."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Outpatient Administration of Teclistamab for Multiple Myeloma
2023. "Outpatient Administration of Teclistamab for Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05972135.
~29 spots leftby Jan 2025
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