Trial · NCT06948084
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Minimal residual disease (MRD) negativity | After 6 cycles of treatment (cycle length = 28 days), assessed at 6 months | Will be determined by the Adaptive Biotechnologies clonoSEQ assay result. Analysis will be performed using Cochran-Mantel-Haenszel (CMH) test, stratified on prior anti-CD38 antibody therapy and investigator's choice of therapy if assigned to Arm A. MRD-negative status requires both MRD negativity and achievement of complete response. Will be summarized using descriptive statistics by treatment arm with two-sided exact binomial 80% confidence intervals (CI), Clopper-Pearson. The corresponding CMH odds ratio (OR) estimate with an 80% CI, and p-value will be reported. Logistic regression will be used to assess the treatment effect within subgroups including but not limited to age 70 status, prior anti-CD38 antibody therapy and high-risk by fluorescence in situ hybridization status. |
| Secondary | Incidence of adverse events (AEs) | Up to 6 cycles (cycle length = 28 days) and overall assessed up to 10 years | Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) and classified by Medical Dictionary for Regulatory Activities (MedDRA) system organ class. Maximum grade toxicity by AE type will be tabulated. Summaries (count and percentages) will be reported by AE type by arm. |
| Secondary | Incidence of grade 3 or higher hematologic and/or non-hematologic AEs | Up to 6 cycles (cycle length = 28 days) and overall assessed up to 10 years | Will be graded according to the NCI CTCAE and classified by MedDRA system organ class. Maximum grade toxicity by AE type will be tabulated. Summaries (count and percentages) will be reported by AE type by arm. Rates of maximum grade 3 or higher (including grade 5) non-hematologic, hematologic and overall toxicity will be calculated along with 90% CIs. AEs will be further analyzed by arm in subsets of serious AEs per protocol, lethal AEs and treatment-emergent AEs status. |
| Secondary | Progression-free survival (PFS) | From randomization until the earlier of progression or death due to any cause, assessed up to 10 years | PFS will be estimated in the treated population using the Kaplan-Meier method and compared between arms using the stratified log-rank test. Stratified cox proportional hazards (PH) regression will be used to produce the treatment hazard ratio (HR) along with the 90% CI, provided PH assumption is valid. Sensitivity analyses excluding untreated patients will be conducted. |
| Secondary | Overall survival (OS) | From randomization to death due to any cause, assessed up to 10 years | OS will be estimated in the treated population using the Kaplan-Meier method and compared between arms using the stratified log-rank test. Stratified cox PH regression will be used to produce the treatment HR along with the 90% CI, provided PH assumption is valid. Sensitivity analyses excluding untreated patients will be conducted. |
| Secondary | Response rates | After 6 cycles of treatment (cycle length = 28 days) and overall, assessed up to 10 years | Will be reported by treatment arm. Rates of stringent complete response (CR) or better, very good partial response (VGPR) or better and partial response (PR) or better will be computed along with 90% CIs in all treated patients. Stratified CMH test will be used to test the difference in VGPR or better rates between arms. Sensitivity analyses excluding untreated patients will be conducted. |
| Other | Event-free survival | From randomization until the earlier of non-protocol therapy, progression, or death due to any cause, assessed up to 10 years | |
| Other | Time to progression | From randomization to time of documented progression or censored at date of last disease evaluation if alive or death not due to disease progression, assessed up to 10 years | |
| Other | Duration of treatment | From randomization to treatment end, or censored at the date of last treatment, assessed up to 10 years | |
| Other | Cumulative dose intensity | Up to 24 months (cycle length = 28 days) | Will be defined as the sum of all doses taken across all cycles. Will be characterized using descriptive statistics. |
| Other | Number of dose modifications (DM) | Up to 6 cycles (cycle length = 28 days) and overall, assessed up to 10 years | The number of DMs, DM status (planned versus unplanned) and reason for DM by cycle and overall treatment will be characterized using descriptive statistics. Reasons off treatment and every DM will also be tabulated. |
| Other | Relative dose intensity | Up to 6 cycles (cycle length = 28 days) and overall, assessed up to 10 years | Will be defined as the dose received as percentage of planned dose of each cycle. Will be characterized using descriptive statistics. |
| Other | Incidence of venous thromboembolism (VTE) | Up to 10 years | The cumulative incidence of VTE overall and within dichotomized risk groups will be assessed using Fine and Gray model with and without adjustment for age and competing risk of death. To assess the impact of thrombosis on survival, incidence of VTE will be treated as a time-dependent covariate in Cox PH regression models of survival follow-up. Computed HR and 90% CI will be reported. Additionally, landmark (LM) analyses with patients alive classified by occurrence of VTE after 6 cycles of treatment based on Kaplan Meier from that timepoint will be conducted. |
| Other | Incidence of arterial thrombotic events (ATE) | Up to 10 years | The cumulative incidence of ATE overall and within dichotomized risk groups will be assessed using Fine and Gray model with and without adjustment for age and competing risk of death. To assess the impact of thrombosis on survival, incidence of ATE will be treated as a time-dependent covariate in Cox PH regression models of survival follow-up. Computed HR and 90% CI will be reported. Additionally, LM analyses with patients alive classified by occurrence of ATE after 6 cycles of treatment based on Kaplan Meier from that timepoint will be conducted. |
| Other | Incidence of clinically significant bleeding events | Up to 10 years | Will be assessed according to concurrent thromboprophylaxis type and dose. |
| Other | Venous thromboembolism risk | At baseline and at time of VTE, assessed up to 24 months | IMPEDE and SAVED risk scores will be calculated. Patients will be classified into 3 risk groups (low, intermediate, high) and dichotomized (low vs. intermediate-high) based on IMPEDE risk score while patients will be classified into 2 risk groups (low and high) based on SAVED risk score. Descriptive statistics will be used to characterize IMPEDE and SAVED risk variables and scores. The accuracy of IMPEDE and SAVED risk models will be assessed based on positive predictive value. |
| Other | Thromboprophylaxis | Up to 24 months (cycle length = 28 days) | Descriptive statistics (count and percentages) will be used to characterize thromboprophylaxis strategies (type and dose). |
| Other | Impact of MRD-negative status on PFS and OS | After 6 cycles (cycle length = 28 days) | Kaplan Meier plots will be produced by MRD-negative status as defined in this study. Alternative definitions of MRD-negative status and MRD levels will also be assessed. MRD assessment will also be evaluated in the context of disease response based on standard International Myeloma Working Group (IMWG) criteria. The proportion of patients with marrow MRD-negative status will be cross-tabulated with IMWG response categories (PR, VGPR, CR, stringent complete response). Sensitivity analyses excluding untreated patients will be conducted. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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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