Trial · NCT04818372
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose escalation: Number of Participants with a Dose-Limiting Toxicity (DLT) | Up to 21 days after the first dose | |
| Primary | Dose escalation and Dose expansion: Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 | Up to 30 days after the last dose of CM313 or until the start of subsequent anticancer therapy, if earlier | |
| Primary | Dose expansion: To evaluate the activity of CM313 in combination with Rd/Dexamethasone as assessed by overall response rate (ORR) in RRMM patients | Up to 24 months | ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria. |
| Secondary | Dose escalation: AUC to the last quantifiable concentration [AUC(0-last)], over the dosing interval [AUC(0-tau)], extrapolated to infinity [AUC(0-inf), time to Cmax (tmax), apparent half-life (t1/2), systemic clearance (CL). | 21 days after the first dose | |
| Secondary | Dose escalation and Dose expansion: AUC(0-last), AUC(0-tau), Cmax, t1/2, systemic clearance (CL), volume of distribution (Vz, Vss), minimum concentration (Cmin), Ctrough, accumulation ratios for Cmax and AUC(0-tau) for multiple doses | up to 24 months | |
| Secondary | Dose escalation and Dose expansion: Incidence of anti-CM313 | up to 24 months | |
| Secondary | Dose escalation: Overall Response Rate (ORR) | up to 24 months | ORR is defined as the proportion of participants who have a partial response (PR) or better according to the IMWG criteria. |
| Secondary | Dose escalation and Dose expansion: Clinical Benefit Rate (CBR) | up to 24 months | CBR is defined as the proportion of participants who have a minimal response (MR) or better according to the IMWG criteria. |
| Secondary | Dose escalation and Dose expansion: Duration of Response (DOR) | From the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) (up to 24 months) | DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of PD, per IMWG criteria.or better according to the IMWG criteria. |
| Secondary | Dose escalation and Dose expansion: Time to Response (TTR) | From the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) (up to 24 months) | TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better. |
| Secondary | Dose escalation and Dose expansion: Progression-Free Survival (PFS) | up to 24 months | PFS is defined as time from date of first dose of study drug to date of first documented PD, per IMWG criteria, or death due to any cause, whichever occurs first. |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT04818372/registered