Trial · NCT05455320
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | Up to 6 years 6 months | PFS is defined as time from the date of randomization to the first documentation of disease progression, or death due to any cause, whichever is reported first. |
| Secondary | Overall Response (Partial Response [PR] or Better) | Up to 6 years 6 months | Overall response (PR or better) is defined as percentage of participants who have a PR or better per International Myeloma Working Group (IMWG) criteria. |
| Secondary | Very Good Partial Response (VGPR) or Better Rate | Up to 6 years 6 months | VGPR or better rate is defined as the percentage of participants who achieve a VGPR or better according to IMWG response criteria. |
| Secondary | Complete Response (CR) or Better Rate | Up to 6 years 6 months | CR or better rate is defined as the percentage of participants who achieve CR or better according to IMWG response criteria. |
| Secondary | Overall Minimal Residual Disease (MRD) Negative CR | Up to 6 years 6 months | MRD-negative CR is defined as proportion of participants with CR or stringent CR who achieve MRD negativity at a threshold of 10\^-5 at any timepoint after the first dose of study drug and before disease progression or start of subsequent antimyeloma therapy. |
| Secondary | Overall Survival (OS) | Up to 6 years 6 months | OS is defined as the time from the date of randomization to the date of the participant's death. |
| Secondary | Progression-free Survival on Next-line Therapy (PFS2) | Up to 6 years 6 months | PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as progressive disease as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first. |
| Secondary | Time to Next Therapy (TTNT) | Up to 6 years 6 months | TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment. |
| Secondary | Number of Participants with Adverse Events (AEs) | Up to 6 years 6 months | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. |
| Secondary | Number of Participants with AEs by Severity | Up to 6 years 6 months | Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). |
| Secondary | Serum Concentrations of Talquetamab | Up to 6 years 6 months | Serum concentrations of talquetamab will be reported. |
| Secondary | Serum Concentrations of Daratumumab | Up to 6 years 6 months | Serum concentrations of daratumumab will be reported. |
| Secondary | Number of Participants with Presence of Anti-Drug Antibodies (ADAs) to Talquetamab | Up to 6 years 6 months | Number of participants with presence ADAs to talquetamab will be reported. |
| Secondary | Number of Participants With Presence of Anti-Drug Antibodies (ADAs) to Daratumumab | Up to 6 years 6 months | Number of participants with presence of ADAs to daratumumab will be reported. |
| Secondary | Time to Worsening in Symptoms, Functioning, and Overall Health-Related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) | Up to 6 years 6 months | The MySIm-Q is a disease-specific PRO assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30). |
| Secondary | Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by PROMIS Short Form Version 2.0 -Physical Functioning 8c | Up to 6 years 6 months | The Patient-reported Outcomes Measurement Information System (PROMIS) Short Form Version 2.0 -Physical Function 8c is an 8-item fixed--length short form derived from the PROMIS Physical Function item bank. |
| Secondary | Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 | Up to 6 years 6 months | Time to worsening in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported. |
| Secondary | Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by PRO-CTCAE | Up to 6 years 6 months | The National Cancer Institute's (NCI) PRO-CTCAE is an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability. |
| Secondary | Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L) | Up to 6 years 6 months | The EQ-5D-5L is a generic measure of health status. For purposes of this study, the EQ-5D-5L will be used to generate utility scores for use in cost-effectiveness analyses. |
| Secondary | Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by Patient Global Impression - Severity (PGI-S) | Up to 6 years 6 months | The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and PROMIS SF PF 8c in this population. |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05455320/registered