Trial · NCT05981209
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The recommended phase 2 dose of mezigdomide (CC-92480) in combination with elotuzumab and dexamethasone | Up to 28 days (Cycle 1) | The dose limiting toxicity (DLT) will be defined as one or more of the following toxicities considered to be at least possibly related to the study drug, occurring during cycle 1 of therapy. Furthermore, inability to take \>= 75% of the planned CC-92480 doses, or receive cycle 2 day 1 doses due to a drug-related adverse event occurring in cycle 1 will be considered a DLT. |
| Primary | Incidence of adverse events | Up to 2 years | Adverse events and toxicities of the combination regimen will be summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Toxicities will be assessed overall, as well as by dose level. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. The incidence of severe (grade 3+) adverse events or toxicities will be described. Will also assess tolerability of the regimen through assessing the number of patients who required dose modifications and/or dose delays. In addition, will capture the proportion of patients who go off treatment due to adverse reactions. All patients who have received at least one dose of any of the study regimen will be evaluable for toxicity. |
| Secondary | Time to progression (TTP) | From start of treatment until objective tumor progression; with death as a competing risk, assessed at 1 year | Primary evaluation of antitumor activity of study treatment will be assessed according to IMWG response criteria. For TTP, cumulative incidence rates will be calculated and compared using Gray's test accounting for competing risks. |
| Secondary | Time to response (TTR) | From start of treatment until measurement criteria are first met for PR, very good partial response (VGPR), or complete response (CR) (whichever status is recorded first), assessed at 1 year | Primary evaluation of antitumor activity of study treatment will be assessed according to IMWG response criteria. For TTR, cumulative incidence rates will be calculated and compared using Gray's test accounting for competing risks |
| Secondary | Duration of response (DOR) | From the time measurement criteria are first met for partial response or better (whichever status is recorded first) until the first date of progressive disease or death, assessed at 1 year | DOR will be computed for subjects whose best response is either PR, VGPR, or CR. Primary evaluation of antitumor activity of study treatment will be assessed according to IMWG response criteria. DOR will be analyzed using the Kaplan-Meier method. The probability of survival and median DOR will be calculated together with 95% CIs, and log-rank test will be used for the comparison between patient subgroups. |
| Secondary | Very good partial response (VGPR) or better rates | From start of treatment until disease progression or death, assessed at 1 year | Primary evaluation of antitumor activity of study treatment will be assessed according to IMWG response criteria. VGPR will be analyzed using the Kaplan-Meier method. The probability of survival and median DOR will be calculated together with 95% CIs, and log-rank test will be used for the comparison between patient subgroups. |
| Secondary | Complete Response (CR) | From start of treatment until disease progression or death, assessed at 1 year | Primary evaluation of antitumor activity of study treatment will be assessed according to IMWG response criteria. CR will be analyzed using the Kaplan-Meier method. The probability of survival and median DOR will be calculated together with 95% CIs, and log-rank test will be used for the comparison between patient subgroups. |
| Secondary | Progression free survival (PFS) | From start of treatment until disease progression or death, assessed at 1 year | Primary evaluation of antitumor activity of study treatment will be assessed according to IMWG response criteria. PFS will be analyzed using the Kaplan-Meier method. The probability of survival and median PFS will be calculated together with 95% CIs, and log-rank test will be used for the comparison between patient subgroups. |
| Secondary | Overall survival (OS) | From start of treatment to the date of his or her death, assessed at 1 year | Primary evaluation of antitumor activity of study treatment will be assessed according to IMWG response criteria. OS will be analyzed using the Kaplan-Meier method. The probability of survival and median OS will be calculated together with 95% CIs, and log-rank test will be used for the comparison between patient subgroups. |
| Secondary | Minimal residual disease (MRD) | At final study visit, up to 2 years | Planned for patients suspected of attaining CR. MRD negativity is associated with superior outcomes compared to MRD positivity. |
| Secondary | Changes in lymphocyte subsets with therapy | Up to 2 years | Changes in expression of these markers across time will be explored by dose level graphically. Relationships between changes in lymphocyte subsets, total number and ratio of regulatory T cells will be explored graphically (e.g. side-by-side boxplots) and with quantitative summaries, compared using Mann-Whitney test or Fisher exact test depending on the data type of expression data. |
| Secondary | Changes in immunophenotype of multiple myeloma cells | Up to 2 years | Correlative studies including the changes in expression of these markers across time will be explored by dose level graphically. |
| Secondary | Changes in expression of CRBN, Ikaros, and Aiolos with therapy | Up to 2 years | Changes in expression of these markers across time will be explored by dose level graphically. |
| Secondary | Quality of life (QOL) | At baseline and monthly until study completion, up to 2 years | Measured with the Patient-Reported Outcomes Measurement Information System Global 10 Quality of Life Survey and The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Multiple Myeloma20. A repeated measures linear mixed model will be fit to all QOL scores. The model will include all time points (baseline as reference session 0 and 1-6 or higher for each monthly measure), and a patient-level random effect. A p-value for the difference between baseline QOL and QOL at the end of the study will be obtained from the model, and if the positive difference with p-value is \< 0.05 QOL will be seen as improved. |
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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