Trial · NCT07285239
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 | MRD Negative Status | Up to 86 months | MRD negative status, defined as achieving MRD negativity at 10-5 sensitivity threshold assessed by NGS at least once during the time of confirmed CR or better response per IMWG criteria by Independent Review Committee (IRC); MRD negativity is determined by the Adaptive Biotechnologies clonoSEQ® assay result |
| Primary | Progression-Free Survival (PFS) | Up to 86 months | PFS, defined as the time from the date of randomization to the date of first documented disease progression per IMWG criteria by IRC or death from any cause in the absence of progression, whichever occurs first |
| Secondary | Overall Survival (OS) | Up to 86 months | OS, defined as the time from the date of randomization until the date of death due to any cause |
| Secondary | Best Response of Complete Response (CR) | Up to 86 months | Defined as confirmed CR or better per IMWG criteria by IRC |
| Secondary | Best Response of Very Good Partial Response (VGPR) | Up to 86 months | Defined as confirmed VGPR, CR or better per IMWG criteria by IRC |
| Secondary | Overall Response Rate (ORR) | Up to 86 months | Defined as confirmed PR, VGPR, CR or better per IMWG criteria by IRC |
| Secondary | Duration of Response (DoR) | Up to 86 months | DoR, defined as the time from first documented evidence of partial response (PR) or better until progression (PD) or death due to PD (among participants who achieve confirmed PR or better) by IRC |
| Secondary | MRD Negative Status at 12-Month | Up to 86 months | Defined as achieving MRD negativity at 10-5 sensitivity threshold assessed by NGS in participants achieving confirmed CR or better response per IMWG criteria by Independent Review Committee (IRC) after 12 (+/-3) months; MRD negativity is determined by the Adaptive Biotechnologies clonoSEQ® assay result |
| Secondary | Sustained MRD (sMRD) Negative Status | Up to 86 months | sMRD, defined as achieving MRD negative status at 10-5 sensitivity threshold assessed by NGS at least twice, a minimum of 1 year apart and with no MRD positive result in between, during the time of confirmed CR or better response per IMWG criteria by IRC |
| Secondary | Adverse Events (AEs) | While on study treatment and up to 70 days after the last dose of study medication | Worst Grade 3 or Higher Treatment-Related Non-Hematologic and Overall Toxicity based on CTCAE v6.0 |
| Secondary | AEs Leading to Dose Modifications | While on study treatment and up to 70 days after the last dose of study medication | AEs or Grade ≥ 2 Corneal Events Leading to Dose Modifications or Treatment Discontinuation |
| Secondary | Corneal Events | While on study treatment and up to 70 days after the last dose of study medication | Incidence of Grade ≥ 3 Corneal Events (Keratopathy Visual Acuity (KVA) scale) |
| Secondary | Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Up to 86 months | Frequency and Score of Selected PRO-CTCAE Attributes |
| Secondary | Health-Related Quality of Life (HRQoL) | Up to 86 months | Change from Baseline in HRQoL as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), European Organisation for Research and Treatment of Cancer Quality of Life Multiple Myeloma Questionnaire (EORTC QLQ-MY20), and Functional Assessment of Cancer Therapy - Multiple Myeloma (FACT MM) Subscale |
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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GET https://conductscience.org/api/trials/v1/NCT07285239/registered