Myeloma Multiple study: Off Drug Surveillance
Official title Limited-duration Teclistamab
ClinicalTrials.gov ID: NCT05932680
What this study is testing
- What it's testing
- This study is testing whether stopping teclistamab after 6 to 9 months works as well as keeping it going. It looks at how well the medicine works and how safe it is.
- Who it's for
- You may be able to join if you have multiple myeloma and your cancer has shrunk a lot after 6 to 9 months of teclistamab.
- What's involved
- You would stop taking teclistamab. The team would watch you closely to see if the cancer comes back.
- Time commitment
- The study lasts about 6 months after you stop the medicine.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must be age ≥18 and able to give written, informed consent.
- Participants must have initiated teclistamab (first full dose) 6-9 months prior to enrollment and received an average teclistamab dose of at least...
- Participants must have received a teclistamab dose within 4 weeks prior to enrollment.
- Participants must have had measurable disease according to IMWG criteria within 1 month prior to teclistamab initiation or first full teclistamab dose
- Participants must have achieved a confirmed VGPR or better to teclistamab therapy at any assessment prior to enrollment and have ongoing response...
See the full eligibility criteria
- Participants must be age ≥18 and able to give written, informed consent.
- Participants must have initiated teclistamab (first full dose) 6-9 months prior to enrollment and received an average teclistamab dose of at least 1.5 mg/kg/month since the date of the first 1.5 mg/kg dose.
- Participants must have received a teclistamab dose within 4 weeks prior to enrollment.
- Participants must have had measurable disease according to IMWG criteria within 1 month prior to teclistamab initiation or first full teclistamab dose
- Participants must have achieved a confirmed VGPR or better to teclistamab therapy at any assessment prior to enrollment and have ongoing response (i.e., no disease progression) at time of enrollment per IMWG consensus...
- ≥3 prior lines of therapy (with lines-of-therapy delineated according to IWMG guidelines)
- Refractory to both a proteasome inhibitor and a thalidomide analog.
- Participants must have had an ECOG performance status of 0-2 at time of teclistamab initiation; in addition, ECOG performance status must be 0-1 at time of enrollment.
- Participants must not have known diagnoses of systemic amyloidosis or POEMS syndrome.
The study team makes the final eligibility decision.
Where it is enrolling
- Little Rock, Arkansas, United States
- Iowa City, Iowa, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Little Rock, Arkansas, United States; Iowa City, Iowa, United States; New York, New York, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.