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Limited-duration Teclistamab for Multiple Myeloma

Phase 2
Recruiting
Led By Alfred Garfall, MD
Research Sponsored by Abramson Cancer Center at Penn Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must not have known diagnoses of systemic amyloidosis or POEMS syndrome.
≥3 prior lines of therapy (with lines-of-therapy delineated according to IWMG guidelines)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months after teclistamab discontinuation
Awards & highlights

Study Summary

This trial will study how stopping teclistamab (anti-BCMAxCD3 bispecific antibody) after 6-9 months of treatment affects cancer relapse in patients with a very good partial response. Potential benefits include reduced risk of infection & tumor features that predict durable response.

Who is the study for?
This trial is for adults over 18 with multiple myeloma who've had at least three prior treatments, including a proteasome inhibitor, thalidomide analog, and anti-CD38 antibody. They should have responded well to teclistamab therapy (achieving ≥VGPR) without disease progression when enrolling. Patients must not have systemic amyloidosis or POEMS syndrome and should be in good physical condition.Check my eligibility
What is being tested?
The study tests if patients can safely stop taking teclistamab after a very good response instead of continuing indefinitely. Participants will be monitored closely for signs of the cancer returning. The goal is to see if this approach is as effective as continuous treatment while potentially reducing side effects and resistance.See study design
What are the potential side effects?
While specific side effects are not listed here, stopping teclistamab may reduce risks like infections and prevent the cancer from becoming resistant due to less exposure to the drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have systemic amyloidosis or POEMS syndrome.
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I have had 3 or more treatments for my condition.
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I have responded well to teclistamab therapy without my condition worsening.
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I am 18 or older and can sign a consent form.
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I started teclistamab treatment 6-9 months ago and have been receiving at least 1.5 mg/kg/month.
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My condition did not improve after treatment with proteasome inhibitors and drugs similar to thalidomide.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months after teclistamab discontinuation
This trial's timeline: 3 weeks for screening, Varies for treatment, and six months after teclistamab discontinuation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Failure free at six months following teclistamab discontinuation
Secondary outcome measures
Mean percent change in peripheral blood studies
Quality of life
Rate and type of clinical complications of progressive disease
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Off Drug SurveillanceExperimental Treatment1 Intervention
Participants will stop receiving teclistamab and will be monitored closely for growth of their multiple myeloma. Participants will restart teclistamab if their multiple myeloma starts to grow.

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,569 Total Patients Enrolled
8 Trials studying Multiple Myeloma
260 Patients Enrolled for Multiple Myeloma
Alfred Garfall, MDPrincipal InvestigatorPenn Medicine
7 Previous Clinical Trials
169 Total Patients Enrolled
6 Trials studying Multiple Myeloma
149 Patients Enrolled for Multiple Myeloma

Media Library

Off Drug Surveillance (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05932680 — Phase 2
Multiple Myeloma Research Study Groups: Off Drug Surveillance
Multiple Myeloma Clinical Trial 2023: Off Drug Surveillance Highlights & Side Effects. Trial Name: NCT05932680 — Phase 2
Off Drug Surveillance (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05932680 — Phase 2

Frequently Asked Questions

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

Is Off Drug Surveillance recognized by the FDA as a viable option?

"Considering the lack of available clinical data regarding efficacy, Off Drug Surveillance received a score of 2 due to its minimal safety evidence from Phase 2 trials."

Answered by AI

Is this research currently accessible to participants?

"That is correct. According to the information accessible on clinicaltrials.gov, this medical experiment was first publicized on July 5th 2023 and is actively recruiting patients for participation. Currently, 75 participants are sought from a single location."

Answered by AI

How many persons have enrolled in the experiment?

"Indeed, according to the information on clinicaltrials.gov, this experiment is actively seeking participants. It was first published on July 5th 2023 and recently revised on July 25th 2023. The team are aiming to recruit 75 patients from 1 medical centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Limited-duration Teclistamab
2023. "Limited-duration Teclistamab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05932680.
~44 spots leftby Jun 2025
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