Trial · NCT06768489
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Number of Participants with Dose-limiting Toxicity (DLT) | Up to 28 days | DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity. |
| Primary | Number of Participants with Adverse Events (AEs) by Severity | Up to 3 Years and 3 months | An AE is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. 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 adverse event. |
| Primary | Number of Participants with Clinically Significant Laboratory Abnormalities | Up to 3 Years and 3 months | Participants with clinically significant laboratory abnormalities (hematology and chemistry) will be reported. |
| Secondary | Percentage of Participants With Overall Response Rate | Up to 3 Years and 3 months | Overall response rate is defined as percentage of participants with newly diagnosed multiple myeloma (NDMM), relapsed or refractory multiple myeloma (R/R MM), or high-risk smoldering multiple myeloma (SMM) who have a partial response (PR) or better evaluated by the investigator as per international myeloma working group (IMWG) 2016 criteria. |
| Secondary | Percentage of Participants With Very Good Partial Response (VGPR) or Better Response Rate | Up to 3 Years and 3 months | VGPR or better response rate is defined as the percentage of participants with NDMM, R/R MM, or high-risk SMM who achieve a VGPR or better response (stringent complete response \[sCR\]+ complete response \[CR\]+VGPR) according to the IMWG 2016 criteria. |
| Secondary | Percentage of Participants With CR or Better Response Rate | Up to 3 Years and 3 months | CR or better response rate is defined as the percentage of participants with NDMM R/R MM, or high-risk SMM who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria. |
| Secondary | Percentage of Participants With sCR or Better Response Rate | Up to 3 Years and 3 months | sCR rate is defined as the percentage of participants with NDMM R/R MM, or high-risk SMM who achieve an sCR according to the IMWG 2016 criteria. |
| Secondary | Duration of Response (DOR) | Up to 3 Years and 3 months | DOR 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), as per IMWG 2016 response criteria, or death due to progression, whichever occurs first in participants with NDMM, R/R MM, or high-risk SMM. |
| Secondary | Time to Response (TTR) | Up to 3 Years and 3 months | TTR is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participants with NDMM, R/R MM, or high-risk SMM has met all criteria for PR or better as defined by IMWG 2016 response criteria. |
| Secondary | Percentage of Participants With Hematologic Response As Defined by International Amyloidosis Consensus Criteria | Up to 3 Years and 3 months | Hematologic response is defined as percentage of participants with newly diagnosed amyloid light chain (ND AL) amyloidosis who achieve complete response, very good partial response, partial response, no response and progression as defined by International amyloidosis consensus criteria present in the protocol will be reported. |
| Secondary | DOR as Defined by International Amyloidosis Consensus Criteria | Up to 3 Years and 3 months | DOR 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), as per International amyloidosis consensus criteria, or death due to progression, whichever occurs first in participants with ND AL amyloidosis. |
| Secondary | TTR as Defined by International Amyloidosis Consensus Criteria | Up to 3 Years and 3 months | TTR is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant with ND AL amyloidosis has met all criteria for PR or better as defined by International amyloidosis consensus criteria. |
| Secondary | Serum Concentration of JNJ-79635322 and Daratumumab | Up to 3 Years and 3 months | Serum samples will be analyzed to determine concentrations of JNJ-79635322 and daratumumab. |
| Secondary | Area Under the Serum Concentration Time Curve from Time Zero to Infinity (AUCinf) for JNJ-79635322 and Daratumumab | Up to 3 Years and 3 months | AUCinf for JNJ-79635322 and daratumumab will be reported. |
| Secondary | Area Under the Serum Concentration Time Curve from Time Zero to the Last Measurable Concentration [AUC(0-t)] for JNJ-79635322 and Daratumumab | Up to 3 Years and 3 months | AUC(0-t) for JNJ-79635322 and daratumumab will be reported. |
| Secondary | Area Under the Serum Concentration Time Curve During the Dosing Interval (AUCtau) for JNJ-79635322 and Daratumumab | Up to 3 Years and 3 months | AUCtau for JNJ-79635322 and daratumumab will be reported. |
| Secondary | Maximum Serum Concentration (Cmax) for JNJ-79635322 and Daratumumab | Up to 3 Years and 3 months | Cmax for JNJ-79635322 and daratumumab will be reported. |
| Secondary | Half Life (T1/2) for JNJ-79635322 and Daratumumab | Up to 3 Years and 3 months | T1/2 for JNJ-79635322 and daratumumab will be reported. |
| Secondary | Time to Reach Cmax (Tmax) for JNJ-79635322 and Daratumumab | Up to 3 Years and 3 months | Tmax for JNJ-79635322 and daratumumab will be reported. |
| Secondary | Systemic Clearance (CL/F) for JNJ-79635322 and Daratumumab | Up to 3 Years and 3 months | CL/F for JNJ-79635322 and daratumumab 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.
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