Trial · NCT05050097
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | Up to 1 year and 10 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. |
| Primary | Number of Participants with AEs by Severity | Up to 1 year and 10 months | Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to AE. |
| Primary | Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters | Up to 1 year and 6 months | Number of participants with clinically significant abnormalities in laboratory parameters such as hematology and serum chemistry will be reported. |
| Primary | Number of Participants with Dose Limiting Toxicity (DLT) | Up to 49 days | Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity of grade 3 or higher, clinical laboratory abnormalities, or hematologic toxicity. |
| Secondary | Overall Response Rate (ORR) | Up to 1 year and 10 months | ORR is defined as the percentage of participants who achieve partial response (PR) or better according to the International Myeloma Working Group (IMWG) 2016 criteria. Response to treatment will be evaluated by the investigator based on IMWG criteria. |
| Secondary | Very Good Partial Response (VGPR) or Better Response Rate | Up to 1 year and 10 months | VGPR or better response rate is defined as the percentage of participants who achieve a VGPR or better response (stringent complete response \[sCR\] + complete response \[CR\] +VGPR) according to the IMWG 2016 criteria. |
| Secondary | Complete Response (CR) or Better Response Rate | Up to 1 year and 10 months | CR or better response rate is defined as the percentage of participants who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria. |
| Secondary | Stringent Complete Response (sCR) | Up to 1 year and 10 months | sCR rate is defined as the percentage of participants who achieve an sCR according to the IMWG 2016 criteria. |
| Secondary | Duration of Response | Up to 1 year and 10 months | Duration of response is defined as time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG 2016 criteria, or death due to disease progression, whichever occurs first. |
| Secondary | Time to Response | Up to 1 year and 10 months | Time to response is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant has met all criteria for PR or better. |
| Secondary | Serum Concentration of Talquetamab | Up to 1 year and 10 months | Serum samples will be analyzed to determine concentrations of talquetamab. |
| Secondary | Serum Concentration of Daratumumab | Up to 1 year and 10 months | Serum samples will be analyzed to determine concentrations of daratumumab for treatment regimens B and D. |
| Secondary | Number of Participants with Anti-Drug Antibodies to Talquetamab | Up to 1 year and 10 months | Number of participants with anti-drug antibodies to talquetamab will be reported. |
| Secondary | Number of Participants with Anti-Drug Antibodies to Daratumumab | Up to 1 year and 10 months | Number of participants with anti-drug antibodies to daratumumab will be reported for treatment regimens B and D. |
| Secondary | Number of Participants with Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20) | Up to 1 year and 10 months | Number of participants with anti-drug antibodies to rHuPH20 will be reported. |
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.
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GET https://conductscience.org/api/trials/v1/NCT05050097/registered