Myeloma MultiplePhase 2NCT05932680
Limited-duration Teclistamab
A Phase 2 study testing Off Drug Surveillance in people with Myeloma Multiple, run by Abramson Cancer Center at Penn Medicine at 5 sites in United States.
Trial summary
This is a single-arm, non-inferiority study in which patients who have achieved a very good partial response (VGPR) or better, according to International Myeloma Working Group (IMWG) response criteria, following 6 to 9 months of treatment with teclistamab, a B-cell maturation antigen (BCMA)-directed T-cell engager… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloma Multiple
- What is being tested?
- Off Drug Surveillance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 5 sitesUnited States
- Study dates
- 5 Jul 2023to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 criteria (Appendix 14.3).
- Prior to initiating teclistamab, participants must have received therapy with a proteasome inhibitor, thalidomide analog (lenalidomide or pomalidomide), and an anti-CD38 antibody and meet one of the following criteria:
Show all 10Show fewer
- ≥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.
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Francesca Nugent, 319-356-1727, francesca-nugent@uiowa.edu
Hira Shaikh, MD
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Carolina Schinke, MD, 501-686-8230, CDSchinke@uams.edu
Carolina Schinke, MD
- Recruiting
Columbia University
New York, New York, 10032-3702
George Mellgard, 212-342-5162, sym9026@nyp.org
Rajshekar Chakraborty, MD
- Recruiting
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Alfred Garfall, MD, 215-349-8334, alfred.garfall@pennmedicine.upenn.edu
- Recruiting
Thomas Jefferson University, Honickman Center
Philadelphia, Pennsylvania, 19107
Ariel Kobylak, 267-408-7961, Ariel.Kobylak@jefferson.edu
Lizza Waugh, Elizabeth.Waugh@jefferson.edu
About this study
Official title: Phase 2, Single-Arm, Non-Inferiority Study Of Limited-Duration Teclistamab For Relapsed Refractory Multiple Myeloma
This is a single-arm, non-inferiority study in which patients who have achieved a very good partial response (VGPR) or better, according to International Myeloma Working Group (IMWG) response criteria, following 6 to 9 months of treatment with teclistamab, a B-cell maturation antigen (BCMA)-directed T-cell engager (anti-BCMAxCD3 bispecific antibody), will be offered monitored drug discontinuation. Teclistamab is typically dosed on a regular schedule (every 1-4 weeks) indefinitely until disease progression ("continuous therapy"). Here, a limited-duration regimen will be studied in which patients achieving ≥VGPR after 6-9 months of standard teclistamab dosing will discontinue therapy and resume if laboratory or clinical parameters suggest early disease progression ("limited-duration therapy"). Patients will enter the clinical trial protocol after completing 6-9 months of standard teclistamab monotherapy and achieving ≥VGPR. The study's hypothesis is that the failure probability six months after stopping teclistamab in this patient population will be non-inferior compared to that of historical controls treated with continuous therapy. Reducing drug exposure may be beneficial by reducing risk of infection and reducing anti-BCMA selective pressure toward generation of BCMA-negative relapses. Analysis of minimal residual disease (MRD), tumor features, and bone marrow microenvironment parameters, which will be pursued as exploratory correlative analyses in this study, may identify factors that predict durable response to limited-duration therapy and thereby enable more precise selection of patients likely to benefit from this approach. A subset of patients will be enrolled on a biomarker study for analysis of these exploratory endpoints.
- Conditions
- Myeloma Multiple
- Being tested
- Off Drug Surveillance
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Off Drug SurveillanceOther
After stopping teclistamab, participants will be monitored monthly by standard serum paraprotein studies for disease progression. Participants will resume teclistamab at time of disease progression. After Teclistamab therapy re-initiation on-study, monthly response assessments and data for other study endpoints will be obtained. All participants will undergo peripheral blood collection for correlative research studies at baseline and every two months on-study. Participants who enroll on the biomarker sub-study will undergo bone marrow examination and peripheral blood collection for correlative studies at study entry, at time of disease progression and at six months from enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Off Drug Surveillance | Experimental | 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. Receives: Other: Off Drug Surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure free at six months following teclistamab discontinuation
Failure-free survival is defined as the rate of evaluable individuals who have not experienced any of the following predefined failure events within 6 months of discontinuing teclistamab. Failure is defined as earliest occurrence of any of the following: Participants who progress by IMWG criteria after discontinuing teclistamab, failure to achieve at least minimal response within 90 days after reinitiating teclistamab or failure to resume teclistamab within 90 days of IMWG-defined disease progression. Participants who reinitiate teclistamab due to rise in disease markers before IMWG criteria for disease progression are met, disease progression by IMWG criteria after reinitiation of teclistamab. Initiation of non-teclistamab systemic multiple myeloma therapy. Failure date will be defined as the date of initiating subsequent therapy. Death due to complications of multiple myeloma, teclistamab therapy, or infection
Measured: Six months after teclistamab discontinuation
Secondary outcomes (8)
Time to progression and progression-free survival
Time-to-progression and progression-free survival by IMWG criteria from time of teclistamab discontinuation, using the best response to initial teclistamab course as the baseline for scoring disease progression.
Measured: Two years after teclistamab discontinuation.
Time-to-treatment failure
Time-to-treatment failure as defined in the primary endpoint
Measured: Two years after teclistamab discontinuation
Re-initiation rate
Proportion of subjects who re-initiate teclistamab within six months following discontinuation
Measured: Six months after teclistamab discontinuation
Rate of response to teclistamab re-initiation
Among subjects with IMWG-defined measurable disease at time of teclistamab re-initiation, overall response rate (PR or better) and clinical benefit rate (minimal response or better) to teclistamab upon re-initiating therapy.
Measured: Two years after teclistamab discontinuation
Rate of infectious complications
Frequency of infectious complications from time of teclistamab discontinuation.
Measured: 12 months after teclistamab discontinuation
Rate and type of clinical complications of progressive disease
Frequency of the type and rate of clinical complications of progressive disease (e.g., new osteolytic lesions) from time of teclistamab discontinuation through 6 months post-discontinuation.
Measured: Six months after teclistamab discontinuation
Quality of life
QOL is measured using the MM-FACT instrument. Health-related quality of life (HRQoL) as measured by Functional Assessment of Cancer Therapy - Multiple Myeloma (FACT-MM) questionnaire score at enrollment and monthly post-enrollment assessments. The higher the score, the better the quality of life. Two scores will be derived - FACT-MM Trial Outcome Index (TOI) (range: 0-112) and FACT-MM total score (range: 0-164).
Measured: Two years after teclistamab discontinuation
Mean percent change in peripheral blood studies
Mean percent change in peripheral blood cell counts, immunoglobulin levels, and T cell counts (total and CD4/CD8 subsets) from the time of enrollment through teclistamab resumption and through the end-of-study.
Measured: Two years after teclistamab discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start5 Jul 2023
- Primary completionJan 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myeloma MultipleStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Teclistamab is the study drug. The intervention is the cessation of the drug.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alfred Garfall, MD, Principal investigator, Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932680
- Sponsor's protocol ID
- UPCC 08423
- Other IDs
- IRB 853459
- Status last verified
- Oct 2026
- First submitted
- 8 Jun 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Razzo BM, Midha S, Portuguese AJ, Grajales-Cruz AF, De Menezes Silva Corraes A, Costello P, Liu Y, Sperling AS, Nadeem O, Dima D, Banerjee R, Cowan AJ, Afrough A, Anderson LD Jr, Lieberman-Cribbin A, Kaur G, Goyal A, Atrash S, Ferreri CJ, Voorhees PM, Pasvolsky O, Lee HC, Patel KK, Julian KL, Forsberg PA, Herr MM, Chhabra S, Parrondo RD, Lin Y, Chen A, Susanibar-Adaniya SP, Khouri J, Raza S, Anwer F, Vazquez-Martinez M, Castaneda Puglianini O, Sborov DW, Davis JA, Rossi A, Shune L, Bhurtel J, Hwang WT, Hansen DK, Sidana S, Garfall AL, Richard S. Real-World Experience with Teclistamab for Relapsed/Refractory Multiple Myeloma from the US Myeloma Immunotherapy Consortium. Blood Cancer Discov. 2025 Nov 3;6(6):561-571. doi: 10.1158/2643-3230.BCD-24-0354.
PubMed 40629516
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Single-Arm, Non-Inferiority Study Of Limited-Duration Teclistamab For Relapsed Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05932680
- Acronym / sponsor ID
- UPCC 08423
- Conditions
- Myeloma Multiple
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm, non-inferiority study in which patients who have achieved a very good partial response (VGPR) or better, according to International Myeloma Working Group (IMWG) response criteria, following 6 to 9 months of treatment with teclistamab, a B-cell maturation antigen (BCMA)-directed T-cell engager (anti-BCMAxCD3 bispecific antibody), will be offered monitored drug discontinuation. Teclistamab is typically dosed on a regular schedule (every 1-4 weeks) indefinitely until disease progression ("continuous therapy"). Here, a limited-duration regimen will be studied in which patients achieving ≥VGPR after 6-9 months of standard teclistamab dosing will discontinue therapy and resume if laboratory or clinical parameters suggest early disease progression ("limited-duration therapy"). Patients will enter the clinical trial protocol after completing 6-9 months of standard teclistamab monotherapy and achieving ≥VGPR. The study's hypothesis is that the failure probability six months after stopping teclistamab in this patient population will be non-inferior compared to that of historical controls treated with continuous therapy. Reducing drug exposure may be beneficial by reducing risk of infection and reducing anti-BCMA selective pressure toward generation of BCMA-negative relapses. Analysis of minimal residual disease (MRD), tumor features, and bone marrow microenvironment parameters, which will be pursued as exploratory correlative analyses in this study, may identify factors that predict durable response to limited-duration therapy and thereby enable more precise selection of patients likely to benefit from this approach. A subset of patients will be enrolled on a biomarker study for analysis of these exploratory endpoints.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Teclistamab is the study drug. The intervention is the cessation of the drug.
| Arm | Type | Receives |
|---|---|---|
| Off Drug Surveillance | Experimental | Other: Off Drug SurveillanceParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 criteria (Appendix 14.3).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Off Drug SurveillanceAfter stopping teclistamab, participants will be monitored monthly by standard serum paraprotein studies for disease progression. Participants will resume teclistamab at time of disease progression. After Teclistamab therapy re-initiation on-study, monthly response assessments and data for other study endpoints will be obtained. All participants will undergo peripheral blood collection for correlative research studies at baseline and every two months on-study. Participants who enroll on the biomarker sub-study will undergo bone marrow examination and peripheral blood collection for correlative studies at study entry, at time of disease progression and at six months from enrollment. | Other | Off Drug Surveillance |
Primary outcome
Failure free at six months following teclistamab discontinuation
Time frame: Six months after teclistamab discontinuation
Failure-free survival is defined as the rate of evaluable individuals who have not experienced any of the following predefined failure events within 6 months of discontinuing teclistamab. Failure is defined as earliest occurrence of any of the following: Participants who progress by IMWG criteria after discontinuing teclistamab, failure to achieve at least minimal response within 90 days after reinitiating teclistamab or failure to resume teclistamab within 90 days of IMWG-defined disease progression. Participants who reinitiate teclistamab due to rise in disease markers before IMWG criteria for disease progression are met, disease progression by IMWG criteria after reinitiation of teclistamab. Initiation of non-teclistamab systemic multiple myeloma therapy. Failure date will be defined as the date of initiating subsequent therapy. Death due to complications of multiple myeloma, teclistamab therapy, or infection
8 secondary outcomes
Time to progression and progression-free survival
Time frame: Two years after teclistamab discontinuation.
Time-to-treatment failure
Time frame: Two years after teclistamab discontinuation
Re-initiation rate
Time frame: Six months after teclistamab discontinuation
Rate of response to teclistamab re-initiation
Time frame: Two years after teclistamab discontinuation
Rate of infectious complications
Time frame: 12 months after teclistamab discontinuation
Rate and type of clinical complications of progressive disease
Time frame: Six months after teclistamab discontinuation
Quality of life
Time frame: Two years after teclistamab discontinuation
Mean percent change in peripheral blood studies
Time frame: Two years after teclistamab discontinuation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Derived from this study: PubMed 40629516Razzo BM, Midha S, Portuguese AJ, Grajales-Cruz AF, De Menezes Silva Corraes A, Costello P, Liu Y, Sperling AS, Nadeem O, Dima D, Banerjee R, Cowan AJ, Afrough A, Anderson LD Jr, Lieberman-Cribbin A, Kaur G, Goyal A, Atrash S, Ferreri CJ, Voorhees PM, Pasvolsky O, Lee HC, Patel KK, Julian KL, Forsberg PA, Herr MM, Chhabra S, Parrondo RD, Lin Y, Chen A, Susanibar-Adaniya SP, Khouri J, Raza S, Anwer F, Vazquez-Martinez M, Castaneda Puglianini O, Sborov DW, Davis JA, Rossi A, Shune L, Bhurtel J, Hwang WT, Hansen DK, Sidana S, Garfall AL, Richard S. Real-World Experience with Teclistamab for Relapsed/Refractory Multiple Myeloma from the US Myeloma Immunotherapy Consortium. Blood Cancer Discov. 2025 Nov 3;6(6):561-571. doi: 10.1158/2643-3230.BCD-24-0354.
Related trials for Myeloma Multiple
RecruitingPhase 1
FT836 CAR T-cell Therapy in Combination With Daratumumab in Patients With Relapsed and/or Refractory Multiple Myeloma
Relapse Multiple Myeloma, Refractory Multiple Myeloma
RecruitingObservational study
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Brain Cancer, Breast Cancer
RecruitingPhase 3
A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)
High Risk Smoldering Multiple Myeloma (HR-SMM)
RecruitingPhase 2
Study of HBI0101 (NXC-201) CAR-T Therapy in Multiple Myeloma and Light-Chain Amyloidosis
Multiple Myeloma, Refractory to Standard Treatment, Multiple Myeloma, Relapsed
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alfred Garfall, MD principal investigator
Penn Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Off Drug Surveillance in people with Myeloma Multiple, run by Abramson Cancer Center at Penn Medicine at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leonard Fiannaca, MS (215-662-3173, Leonard.Fiannaca@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure free at six months following teclistamab discontinuation (time frame: Six months after teclistamab discontinuation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05932680, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.