Trial · NCT05572515
A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
NCT05572515, Phase 3, Active not recruiting, Janssen Research & Development, LLC
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma. Trials, record NCT05572515. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05572515
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
- NCT number
- NCT05572515
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 614 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Multiple Myeloma
- Interventions
- Teclistamab, Pomalidomide, Bortezomib, Dexamethasone, Carfilzomib
- First posted
- 2022-10-07
- Last updated
- 2026-11-04
- Other registries' IDs
- eudract:2022-000928-37
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Progression-free Survival (PFS) | Up to 9 years | PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the International myeloma working group (IMWG) 2016 response criteria, or death due to any cause, whichever occurs first. |
| Primary | Part 2: Number of Participants Reporting Cytokine Release Syndrome (CRS) Cases by Severity | Up to 9 years | Severity for CRS will be graded as follows: Grade 1: Fever (Temperature greater than or equal to \[\>=\] 38°C); Grade 2: Fever (Temperature \>=38°C) with either: hypotension and/or hypoxia requiring low-flow nasal cannula or blow-by; Grade 3: Fever (Temperature \>=38°C) with either: hypotension and/or hypoxia requiring high-flow nasal cannula, facemask, nonrebreather mask, or Venturi mask; Grade 4: Fever (Temperature \>=38°C) with either: hypotension requiring multiple vasopressors (excluding vasopressin), and/or hypoxia requiring positive pressure and Grade 5: Death. |
| Secondary | Part 1 and 2: Overall Response (Partial Response [PR] or Better) | Up to 9 years | Overall response (PR or better) is defined as participants who have a PR or better prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria. |
| Secondary | Part 1 and 2: Very Good Partial Response (VGPR) or Better Response | Up to 9 years | VGPR or better (Stringent Complete Response \[sCR\]+Complete Response \[CR\]+VGPR) is defined as participants who achieve a VGPR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria. |
| Secondary | Part 1 and 2: Complete Response (CR) or Better Response | Up to 9 years | CR or better response is defined as participants who achieve a CR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 criteria. |
| Secondary | Part 1: Duration of Response (DOR) | Up to 9 years | DOR is defined as the time interval between the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG 2016 response criteria or death due to any cause, whichever occurs first. |
| Secondary | Part 1: Time to Next Treatment (TTNT) | Up to 9 years | TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment. |
| Secondary | Part 1: Progression-free Survival on Next-line Therapy (PFS2) | Up to 9 years | PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as progressive disease as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first. |
| Secondary | Part 1: Overall Survival (OS) | Up to 9 years | OS is defined as the time from the date of randomization to the date of the participant's death due to any cause. |
| Secondary | Part 1 and 2: Number of Participants with Adverse Events (AEs) by Severity | Up to 9 years | Number of participants with AEs by Severity will be reported. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42212933 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05572515
GET https://conductscience.org/api/trials/v1/NCT05572515/registered?page=2