Trial · NCT06465316
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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. |
| Other | Soluble B-cell maturation antigen levels | At baseline | Values over time will be summarized graphically and descriptively. Paired sample approaches (Wilcoxon signed rank test) for these types of quantitative measures 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT06465316/registered