Trial · NCT04722146
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants with Incidence of Adverse Events (AEs) | Up to 2 year and 5 months | An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. |
| Primary | Number of Participants with AEs by Severity | Up to 2 year and 5 months | Number of participants with AEs by severity will be reported. |
| Primary | Number of Participants with Abnormalities in Laboratory Values | Up to 2 year and 5 months | Number of participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported. |
| Primary | Number of Participants with Dose-Limiting Toxicity (DLT) | Up to Cycle 2 Day 21 (each cycle is of 28 days for Treatment Regimen A and 21 days for Treatment Regimen B) | The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non hematological toxicity of Grade 3 or higher. |
| Secondary | Overall Response Rate (ORR) | Up to 2 year and 5 months | ORR is defined as the proportion of participants who achieve partial response (PR) or better according to the international myeloma working group (IMWG) 2016 criteria. |
| Secondary | Very Good Partial Response (VGPR) or Better Response Rate | Up to 2 year and 5 months | VGPR or better response rate is defined as the proportion 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 2 year and 5 months | CR or better response rate is defined as the proportion of participants who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria. |
| Secondary | Stringent Complete Response (sCR) Rate | Up to 2 year and 5 months | sCR rate is defined as the proportion of participants who achieve an sCR according to the IMWG 2016 criteria. |
| Secondary | Duration of Response | Up to 2 year and 5 months | Duration of response is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG criteria. |
| Secondary | Time to Response | Up to 2 year and 5 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 Concentrations of Teclistamab | Up to 2 year and 5 months | Serum concentrations of teclistamab will be reported. |
| Secondary | Serum Concentrations of Daratumumab | Up to 2 year and 5 months | Serum concentrations of daratumumab will be reported. |
| Secondary | Serum Concentrations of Nirogacestat | Up to 2 year and 5 months | Serum concentration of nirogacestat will be reported. |
| Secondary | Number of Participants with Presence of Anti-Drug Antibodies to Teclistamab | Up to 2 year and 5 months | Number of participants with anti-drug antibodies to teclistamab will be reported for all treatment regimens. |
| Secondary | Number of Participants with Presence of Anti-Drug Antibodies to Daratumumab | Up to 2 year and 5 months | Number of participants with anti-drug antibodies to daratumumab will be reported for Treatment Regimen A, B, E and F. |
| Secondary | Number of Participants with Presence of Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20) | Up to 2 year and 5 months | Number of participants with anti-drug antibodies to rHuPH20 will be reported for Treatment Regimen A, B, E and F. |
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/NCT04722146/registered