Trial · NCT06465316
Testing Teclistamab (TECVAYLI) in Combination With Iberdomide for Relapsed or Refractory Multiple Myeloma
NCT06465316, Phase 1, Recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing Teclistamab (TECVAYLI) in Combination With Iberdomide for Relapsed or Refractory Multiple Myeloma. Trials, record NCT06465316. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06465316
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing Teclistamab (TECVAYLI) in Combination With Iberdomide for Relapsed or Refractory Multiple Myeloma
- NCT number
- NCT06465316
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 26 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Multiple Myeloma, Refractory Multiple Myeloma
- Interventions
- Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Iberdomide, Magnetic Resonance Imaging, Positron Emission Tomography, Teclistamab
- First posted
- 2024-06-18
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended phase 2 dose (RP2D) of iberdomide when combined with teclistamab | At 28 days | The RP2D will be defined as the pharmacologically optimal dose of iberdomide that can be combined with teclistamab and will be selected based on all available pharmacokinetic, pharmacodynamic, target engagement, efficacy, safety and tolerability data. |
| Primary | Maximum tolerated dose (MTD) of iberdomide when combined with teclistamab | At 28 days | The MTD will be is defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 8 new patients). |
| Secondary | Incidence of adverse events (AEs) | Up to 4 weeks after last dose of study treatment | AEs will be described and graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine patterns. The relationship of the AEs to the study treatment will be taken into consideration. |
| Secondary | Overall response rate (ORR) | Up to 2 years after last dose of study treatment | The ORR will be estimated by the total number of patients who achieve a stringent complete response, complete response, very good partial response, or partial response divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true overall response rate will be calculated. |
| Secondary | Minimal residual disease (MRD) negativity | Up to 2 years after last dose of study treatment | MRD negativity will be summarized descriptively at each specified timepoint. |
| Secondary | Progression-free survival (PFS) | From registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 2 years after last dose of study treatment | The distribution of PFS will be estimated using the method of Kaplan-Meier. |
| Secondary | Time to progression | From registration to the earliest date of documentation of disease progression, assessed up to 2 years after last dose of study treatment | The distribution of time to progression will be estimated using the method of Kaplan-Meier. |
| Secondary | Duration of response (DOR) | From earliest documentation of disease response to disease progression, assessed up to 2 years after last dose of study treatment | The distribution of DOR will be estimated using the method of Kaplan-Meier. |
| Secondary | Overall survival (OS) | From registration to death due to any cause, assessed up to 2 years after last dose of study treatment | The distribution of OS will be estimated using the method of Kaplan-Meier. |
| Other | Tumor immune microenvironment | Up to 2 years after last dose of study treatment | Flow cytometry will be utilized to assess the tumor immune microenvironment in the bone marrow and peripheral blood at baseline and during active treatment at specified time points. Values over time will be summarized graphically and descriptively. Paired sample approaches (Wilcoxon signed rank test) will be used to assess differences over time. The relationship between changes over time in each measure with response outcome measures will be explored using Wilcoxon's rank sum test. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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.
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 |
|---|---|---|---|---|---|
| UM1CA186709 | Dana-Farber/Harvard Cancer Center Experimental Therapeutics Clinical Trials Network Site (DF/HCC ETCTN Site) | SHAPIRO, GEOFFREY I.; FLAHERTY, KEITH T; KUFE, DONALD W. | DANA-FARBER CANCER INST | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
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.
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/NCT06465316
GET https://conductscience.org/api/trials/v1/NCT06465316/registered