Trial · NCT06348108
Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
NCT06348108, Phase 1, Recruiting, Alfred Chung, MD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma. Trials, record NCT06348108. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06348108
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
- NCT number
- NCT06348108
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 32 participants, estimated
- Lead sponsor
- Alfred Chung, MD
- Conditions
- Multiple Myeloma, Refractory Multiple Myeloma, Relapsed Multiple Myeloma
- Interventions
- Talquetamab, Iberdomide, Dexamethasone, Bone Marrow Biopsy
- First posted
- 2024-04-04
- Last updated
- 2026-03-13
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of participants reporting treatment-emergent adverse events (AEs) (Dose Escalation Cohorts) | Up to 1 cycle (Cycles are 28 days in length) | Safety will be evaluated for the population of participants who received at least one dose of study drug. Treatment-emergent AEs will be graded by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
| Primary | Proportion of participants experiencing Dose-Limiting Toxicity (DLTs) (Dose Escalation Cohorts) | Up to 1 cycle (Cycles are 28 days in length) | Maximum tolerated dose (MTD) will be defined as the highest dose at which no more than one instance of DLT is observed among 6 participants treated. |
| Primary | Recommended phase 2 dose (RP2D) (Dose Escalation Cohorts) | Up to 1 cycle (Cycles are 28 days in length) | RP2D will be defined as the MTD to be evaluated in the expansion cohort based on safety and preliminary activity of at least 2 dose levels (6 patients treated/dose level). |
| Primary | Proportion of participants experiencing Dose-Limiting Toxicity (DLTs) (Dose Expansion Cohort) | Up to 3 years | The frequency, type, and severity (grade) of each DLT will be reported |
| Primary | Objective response rate (ORR) (Dose Expansion Cohort) | Up to 3 years | ORR will be defined as all responses greater than or equal to a partial response (PR) (i.e., PR, very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) per International Myeloma Working Group (IMWG) definition). Under Simon's two-stage design, final efficacy evaluation for the primary endpoint will calculate the uniformly minimum variance unbiased estimator, p-value and 95% CI for the response rates. |
| Secondary | Objective response rate (ORR) (Dose Escalation Cohorts) | Up to 3 years | ORR will be defined as all responses greater than or equal to a partial response (i.e., PR, VGPR, CR, or sCR per IMWG definition). Will be summarized using frequency and percentage, along with 95% CIs. |
| Secondary | Number of participants achieving VGPR or CR and MRD (negative (-)) response | Up to 3 years | MRD will be defined as achieving ≥ VGPR and MRD (-) response will be defined as having \< 1 multiple myeloma clone per 100,000 bone marrow cells (10-5) by next-generation sequencing (NGS) (clono sequence (seq); 10-5). Will be reported for the entire population and for those treated at the MTD. |
| Secondary | Proportion of participants with treatment-related adverse events | Up to 3 years | Toxicity will be measured by CTCAE version 5.0; cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome (ICANS) will be assessed according to the American Society for Transplantation and Cellular Therapy guidelines; neurological treatment-emergent adverse events that are not assessed as ICANS should be graded per CTCAE version 5.0 and managed by per institutional guidelines. |
| Secondary | Changes in scores on the European Organization for Research and Treatment of Cancer - Quality of Life questionnaire (EORTC-QLQ-C30) over time | Up to 3 years | The functional domains measure the quality of life in Physical functioning, Role functioning, Emotional functioning, Cognitive functioning, Social functioning. Scores consists of responses to items with responses ranging from 1="Not at all" to 4="Very Much". The raw score is calculated by estimating the mean of the items that make up each domains with a resulting total range of 1 - 4. These scores are then transformed to standardized scale score, so that scores range from 0 to 100. A high score for the functional domains represents a high level of functioning. |
| Secondary | Changes in scores on the EORTC QLQ- Multiple Myeloma Questionnaire (EORTC-QLQ-M20) over time | Up to 3 years | The EORTC QLQ-MY20 is a 20-item questionnaire that is designed to measure the quality of life of people with multiple myeloma. Scores consists of responses to items addressing multiple myeloma-related symptoms and quality of life issues with responses ranging from 1="Not at all" to 4="Very Much". The raw score is calculated by estimating the mean of the items that make up each domains with a resulting total range of 1 - 4. These scores are then transformed to standardized scale score, so that scores range from 0 to 100. A high score for the functional domains represents a high level of functioning. |
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.
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/NCT06348108
GET https://conductscience.org/api/trials/v1/NCT06348108/registered