Trial · NCT06179888
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of dose-limiting toxicities (safety run-in) | The first 3 months of therapy | |
| Primary | Progression-free survival (PFS) (randomized phase II) | From randomization to the time of progression and/or death, assessed up to 4 years | Final analyses will use log-rank test statistics to compare the PFS distributions between the treatment arms. Will also evaluate differences in PFS between the treatment arms using a stratified log-rank test. In addition, the methods of Kaplan and Meier will be used to graphically evaluate these distributions as well as to estimate the median PFS and corresponding 95% confidence intervals. Further, will also estimate the 1- and 2-year PFS rates for each treatment arm along with corresponding 95% confidence intervals. Finally, Cox proportional hazards models will be used to evaluate the impact of treatment arm on PFS. |
| Secondary | Incidence of adverse events | Up to 4 years | Adverse events will be collected and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 criteria. For CTCAE data, the maximum grade for each type of adverse will be recorded for each patient, and described using frequency tables. All-cause adverse events will be summarized as well as treatment-related adverse events, with particular focus on grade 3+ non-hematologic adverse events and grade 4+ hematologic events. Frequency tables will be reviewed to identify patterns. The overall adverse event severity will be compared between treatment arms using a chi-square test (or Fisher's exact test if the data in contingency table is sparse). |
| Secondary | Number of treatment cycles received (tolerability) | Up to 4 years | Will be summarized. |
| Secondary | Proportion of patients with dose modifications, omissions, and/or delays (tolerability) | Up to 4 years | Will be summarized. |
| Secondary | Proportion of patients who go off treatment due to adverse events | Up to 4 years | Will be summarized. |
| Secondary | Overall survival (OS) | From randomization until death from any cause, assessed up to 4 years | The Kaplan-Meier method will be used to estimate OS for each treatment arm, with 1- and 2-year OS estimates and OS medians along with their 95% confidence intervals. For the comparison of the treatment arms, will use a one-sided log-rank test to compare the OS distributions between treatment arms. Will also evaluate the influence of arm on OS using stratified and unstratified multivariable Cox proportional hazards models. |
| Secondary | Best response achieved while on study | Up to 4 years | Will calculate these rates by treatment arm along with corresponding 95% binomial confidence intervals. Logistic regression models may also be used to assess differences in the ability to deepen or convert to a response between treatment arms. Minimal residual disease (MRD) will be assessed as an aspect of response assessment. |
| Secondary | Proportion of patients who improve their status | After randomization, up to 4 years | Will calculate these rates by treatment arm along with corresponding 95% binomial confidence intervals. Logistic regression models may also be used to assess differences in the ability to deepen or convert to a response between treatment arms. MRD will be assessed as an aspect of response assessment. |
| Other | MRD-negativity rate | At start of maintenance and at one year post-initiation of maintenance or observation | Will evaluate and identify patients in MRD-negative complete response (CR)/stringent CR (sCR) versus patients who are not in MRD-negative CR/sCR, both from pre-registration (before start of maintenance iberdomide vs. active monitoring) and at the follow-up time points. These will be summarized as proportions within each of the randomization arms at each time point. Assuming that the number of MRD-negative CR/sCR patients is binomially distributed, will calculate corresponding 95% binomial confidence intervals for these rates as well. |
| Other | Sustained MRD-negativity rate | Up to 4 years | Will evaluate and identify patients in MRD-negative CR/sCR versus patients who are not in MRD-negative CR/sCR, both from pre-registration (before start of maintenance iberdomide vs. active monitoring) and at the follow-up time points. These will be summarized as proportions within each of the randomization arms at each time point. Assuming that the number of MRD-negative CR/sCR patients is binomially distributed, will calculate corresponding 95% binomial confidence intervals for these rates as well. |
| Other | Rate of conversion from MRD-positive to MRD-negative | Up to 4 years | Will assess the proportion of patients who had detectable disease at randomization who were able to achieve MRD-negative CR/sCR status after treatment with iberdomide. |
| Other | Peripheral blood immunophenotype | Before and during maintenance therapy or observation | Continuous measures of immune cell subsets will be evaluated using side-by-side boxplots to show differences between treatment arms, and two-sample t-tests will be used to assess quantitative differences in the mean levels of these measures between arms. |
| Other | Persistence of chimeric antigen receptor T-cells | At cycle 12 | |
| Other | B-cell maturation antigen (BCMA) protein expression | Up to 4 years | Will evaluate protein expression by immunohistochemistry on myeloma cells from patients that have relapsed/recurrent disease. Will summarize the BCMA expression status at baseline and evaluate how these associate with PFS using Cox regression models, to evaluate how treatment arm may modify this influence. Changes in this status can be captured both graphically as well as a time-dependent covariate in the model for PFS. In a similar manner, will also evaluate expression intensity. This will be done in those with BCMA expression present, but also across all patients. Differences in changes in these expression intensity levels before versus after study registration monitoring will be compared between treatment arms. Changes in this status will also be evaluated and how these may differ between patients treated with maintenance iberdomide vs. active monitoring using logistic generalized estimating equation models. |
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.
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GET https://conductscience.org/api/trials/v1/NCT06179888/registered