Trial · NCT07463807
Testing the Investigational Medication Combination of Teclistamab and Pomalidomide Compared to the Usual Treatment (Carfilzomib, Pomalidomide, and Dexamethasone) for Patients With Multiple Myeloma Who Have Relapsed Shortly After Treatment
NCT07463807, Phase 1, Phase 2, Recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Testing the Investigational Medication Combination of Teclistamab and Pomalidomide Compared to the Usual Treatment (Carfilzomib, Pomalidomide, and Dexamethasone) for Patients With Multiple Myeloma Who Have Relapsed Shortly After Treatment. Trials, record NCT07463807. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07463807
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Testing the Investigational Medication Combination of Teclistamab and Pomalidomide Compared to the Usual Treatment (Carfilzomib, Pomalidomide, and Dexamethasone) for Patients With Multiple Myeloma Who Have Relapsed Shortly After Treatment
- NCT number
- NCT07463807
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 162 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Multiple Myeloma, Refractory Multiple Myeloma
- Interventions
- Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Carfilzomib, Computed Tomography, Dexamethasone, FDG-Positron Emission Tomography, Fludeoxyglucose F-18, Pomalidomide, Teclistamab
- First posted
- 2026-03-11
- Last updated
- 2026-10-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of dose limiting toxicities (Phase Ib) | During cycle 2 (cycle length = 28 days) | Will be defined by the toxicities (per National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\] 5.0)possibly, probably, or definitely related to the combination regimen after the teclistamab dose is stable and the combination of teclistamab and pomalidomide has been administered for one full cycle. |
| Primary | Rate of minimal residual disease negativity (Phase II) | After 9 cycles of treatment (cycle length = 28 days) | Will be determined by the Adaptive Biotechnologies clonoSEQ, registered trademark, assay results. Analysis will be a comparison using Cochran-Mantel-Haenszel (CMH) test, stratified on prior autologous stem cell transplant, CD38 antibody refractory and high risk at registration. The CMH estimate of odds ratio with 80% confidence interval (CI) and p-value will be reported. The treatment effect will be evaluated in select subgroups including stratification factors as well as PI-exposed or not and 1st or 2nd relapse. Additionally, logistic regression will be used to assess the treatment effect after adjusting for known prognostic factors. |
| Secondary | Progression-free survival | From randomization until the earlier of progression or death due to any cause or censored at date of last disease evaluation, assessed up to 10 years | Will be estimated in the eligible and randomized population using the Kaplan-Meier method and compared between arms using the stratified log-rank test. Stratified cox proportional hazards (PH) regression will be used to produce the treatment hazard ratio (HR; Arm C/Arm D) along with the 90% CI, provided PH assumption is valid. Sensitivity analyses excluding untreated patients will be conducted. |
| Secondary | Overall survival | From randomization to death due to any cause, or censored at date last known alive, assessed up to 10 years | Will be estimated in the eligible and randomized population using the Kaplan-Meier method and compared between arms using the stratified log-rank test. Stratified cox PH regression will be used to produce the treatment HR (Arm C/Arm D) along with the 90% CI, provided PH assumption is valid. Sensitivity analyses excluding untreated patients will be conducted. |
| Secondary | Incidence of adverse events (AE) | Up to 30 days after last dose of study treatment | Will be graded according to NCI CTCAE v 5.0 and classified by Medical Dictionary for Regulatory Activities system organ class. Maximum grade toxicity by AE type will be tabulated. Summaries (count and percentages) will be reported by AE type by arm. Rates of maximum grade 3 or higher (including grade 5) non-hematologic, hematologic and overall toxicity will be calculated along with 90% CIs. AEs will be further analyzed by arm in subsets of serious adverse events per protocol, lethal AEs and treatment-emergent adverse events status. |
| Secondary | Best response | By cycles 12 and 24 (cycle length = 28 days) | Will be based on International Myeloma Working Group uniform criteria and will include rates of partial response (PR), very good PR, complete response (CR) and stringent CR. |
Source ClinicalTrials.gov
Outcomes0
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180820 | ECOG-ACRIN Network Group Operations Center | ODwyer, Peter J; SCHNALL, MITCHELL D. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT07463807
GET https://conductscience.org/api/trials/v1/NCT07463807/registered