Trial · NCT07891871
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of early severe treatment-related toxicity during step-up dosing | Time Period between 2024-2028 | Incidence of early severe treatment-related toxicity during step-up dosing, defined as: * Grade ≥3 CRS and/or ICANS, and/or * Unplanned hospital admission during step-up phase |
| Primary | Incidence of serious infection during treatment | Time Period between 2024-2028 | Incidence of serious infection during treatment, defined as: • Infection requiring hospital admission, ICU admission, or resulting in death |
| Secondary | Supportive care and infection-related management | Time Period between 2024-2028 | • Utilisation of immunoglobulin replacement therapy (IVIG/SCIG), including initiation, duration, and treatment intensity |
| Secondary | Subgroup and implementation variation analyses | Time Period between 2024-2028 | Associations between outcomes and: * Renal impairment * Prior BCMA-directed therapy exposure and refractoriness * Prior immunomodulatory (pomalidomide) refractoriness * Hospital type (tertiary centre vs district general hospital) * Socioeconomic deprivation index * Age and frailty (using simplified IMWG frailty score) * Ethnicity * Subsequent lines of therapy, including use of other bispecific antibodies |
| Secondary | Disease response and survival outcomes | Time Period between 2024-2028 | a. Overall Response Rate (ORR) • Proportion of participants achieving a partial response or better, including VGPR and complete response (CR), according to standard disease response criteria. |
| Secondary | Disease response and survival outcomes | Time Period between 2024-2028 | b: Progression-Free Survival (PFS) • Time from initiation of treatment to disease progression or death from any cause. |
| Secondary | Disease response and survival outcomes | Time Period between 2024-2028 | c: Progression-Free Survival 2 (PFS2) • Time from initiation of treatment to second disease progression or death from any cause. |
| Secondary | Disease response and survival outcomes | Time Period between 2024-2028 | d: Overall Survival (OS) • Time from initiation of treatment to death from any cause. |
| Secondary | Healthcare resource utilisation | Time Period between 2024-2028 | a: Hospitalisation Rate • Proportion of participants requiring hospital admission during step-up dosing and the early treatment period. |
| Secondary | Healthcare resource utilisation | Time Period between 2024-2028 | b: Length of Hospital Stay • Total number of inpatient bed-days per participant during the study period. |
| Secondary | Healthcare resource utilisation | Time Period between 2024-2028 | c: Emergency Admission Rate • Number or proportion of participants requiring emergency admission related to CRS, ICANS, or infection. |
| Secondary | Healthcare resource utilisation | Time Period between 2024-2028 | d: Treatment Setting • Proportion of treatment episodes delivered in the inpatient versus ambulatory/outpatient setting |
| Secondary | Treatment exposure, dosing and delivery intensity | Time Period between 2024-2028 | a: Delivered Dose Intensity • Proportion of planned treatment delivered over the treatment period. |
| Secondary | Treatment exposure, dosing and delivery intensity | Time Period between 2024-2028 | b: Treatment Duration • Time from first to last treatment administration. |
| Secondary | Treatment exposure, dosing and delivery intensity | Time Period between 2024-2028 | c: Dose Delays • Number and duration of treatment delays. |
| Secondary | Treatment exposure, dosing and delivery intensity | Time Period between 2024-2028 | d: Dose Modifications • Frequency of dose reductions, omissions, interruptions, or schedule modifications. |
| Secondary | Treatment exposure, dosing and delivery intensity | Time Period between 2024-2028 | e: Treatment Discontinuation • Proportion of participants permanently discontinuing treatment and reason for discontinuation. |
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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