Trial · NCT04643002
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 31
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1 (dose finding, experimental substudies): Determination of recommended dose of novel agents in combination with isatuximab | Through the end of cycle 1 (approximately 6 weeks) | Determination or confirmation of the dose will be based on: safety and tolerability in terms of TEAEs/SAEs, dose-limiting toxicity occurrence, and laboratory parameters available information on PK (if appropriate) and biomarkers. |
| Primary | Part 2 (expansion, controlled experimental substudies): VGPR Rate (Rate of Very Good Partial Response Rate or Better) | Up to approximately 28 months after the First patient in or scheduled assessment | VGPR or better rate is defined as the percentage of participants with a VGPR or better as defined by the 2016 IMWG response criteria, assessed by Investigator based on central laboratory values and local imaging. |
| Primary | Part 2 (expansion, independent experimental substudies): Overall Response Rate (ORR) in independent experimental substudies | Up to approximately 28 months after the First patient in or scheduled assessment | ORR, defined as the proportion of participants with stringent complete response (sCR), complete response (CR), VGPR, or partial response (PR), according to the 2016 IMWG criteria assessed by Investigator based on central laboratory values and local imaging. |
| Secondary | Part 1 (dose finding, experimental substudies): ORR | Up to approximately 28 months after the First patient in or scheduled assessment | ORR, defined as the proportion of participants with stringent complete response (sCR), complete response (CR), VGPR, or partial response (PR), according to the 2016 IMWG criteria assessed by Investigator based on central laboratory values and local imaging. |
| Secondary | Part 2 (expansion, controlled experimental substudies): ORR | Up to approximately 28 months after the First patient in or scheduled assessment | ORR, defined as the proportion of participants with stringent complete response (sCR), complete response (CR), VGPR, or partial response (PR), according to the 2016 IMWG criteria assessed by Investigator based on central laboratory values and local imaging. |
| Secondary | Part 1 (dose finding, experimental substudies): VGPR or better | Up to approximately 28 months after the First patient in or scheduled assessment | VGPR or better rate is defined as the percentage of participants with a VGPR or better as defined by the 2016 IMWG response criteria, assessed by Investigator based on central laboratory values and local imaging. |
| Secondary | Part 2 (expansion, independent experimental substudies): VGPR or better | Up to approximately 28 months after the First patient in or scheduled assessment | VGPR or better rate is defined as the percentage of participants with a VGPR or better as defined by the 2016 IMWG response criteria, assessed by Investigator based on central laboratory values and local imaging. |
| Secondary | Clinical benefit rate (CBR) in each treatment arm | Up to approximately 28 months after the First patient in or scheduled assessment | CBR, defined as the proportion of participants with sCR, CR, VGPR, PR, or minimal response, according to the 2016 IMWG criteria assessed by Investigator based on central laboratory values and local imaging. |
| Secondary | Duration of Response (DOR) in each treatment arm | Up to approximately 28 months after the First patient in or scheduled assessment | DOR, defined as the time from the date of the first response that is subsequently confirmed for patients achieving PR or better to the date of first documented PD or death, whichever happens first. |
| Secondary | Time to First Response (TT1R) in each treatment arm | Up to approximately 28 months after the First patient in or scheduled assessment | TT1R, defined as the time from the date of first treatment to the date of first response (PR or better) that is subsequently confirmed. |
| Secondary | Time to Best Response (TTBR) in each treatment arm | Up to approximately 28 months after the First patient in or scheduled assessment | TTBR, defined as the time from the date of first treatment to the date of first occurrence of best overall response (PR or better) that is subsequently confirmed. |
| Secondary | Number of participants with treatment emergent adverse events and serious adverse events in each treatment arm | Up to approximately 28 months after the First patient in or scheduled assessment | Safety and tolerability assessed in terms of adverse events/SAEs, including second primary malignancies, laboratory parameters, vital signs, and findings from physical examination. |
| Secondary | Progression-free survival (PFS) in each treatment arm | Up to approximately 28 months after the First patient in or scheduled assessment | PFS is defined as the time from the date of first treatment to disease progression based on the Investigator assessment according to 2016 IMWG criteria or death from any cause, whichever happens first. |
| Secondary | Overall Survival (OS) in each treatment arm | Up to approximately 28 months after the First patient in or scheduled assessment | OS is defined as the time from the date of first treatment to death from any cause. |
| Secondary | Immunogenicity of isatuximab and novel agents | Multiple timepoints up to approximately 28 months after the First patient in or scheduled assessment | Incidence of anti-drug antibodies (ADAs) for novel agents (experimental arms) and isatuximab. |
| Secondary | Concentration of novel agents (experimental arms) and isatuximab (Ctrough) | Multiple timepoints during Cycle 1. The cycle is 28 days. | |
| Secondary | Disease-specific HRQL will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30) | On Day1 Cycle 1, then every 2 cycles for the first year; then every 3 cycles thereafter, at end of treatment and at first follow-up visit. The cycle is 28 days. | The EORTC QLQ-C30 will be used to assess cancer-specific HRQL, disease and treatment-related symptoms and impact of symptoms. This endpoint will be assessed for Part 1 (dose optimization, independent and controlled experimental substudies) and Part 2 (expansion, independent and controlled experimental substudies). |
| Secondary | Disease- and treatment-related quality of life will be assessed using the EORTC multiple myeloma module (QLQ-MY20) questionnaire | On Day1 Cycle 1, then every 2 cycles for the first year; then every 3 cycles thereafter, at end of treatment and at first follow-up visit. The cycle is 28 days. | The EORTC QLQ-MY20 will be used to measure myeloma-specific HRQL, disease and treatment-related symptoms and impact of symptoms. This endpoint will be assessed for Part 1 (dose optimization, independent and controlled experimental substudies) and Part 2 (expansion, independent and controlled experimental substudies). |
| Secondary | Global impact of side effects will be assessed using the Functional Assessment of Cancer Therapy (FACT-G) (GP5) | On Day1 Cycle 1, then every 2 cycles for the first year; then every 3 cycles thereafter, at end of treatment and at first follow-up visit. The cycle is 28 days. | A single item from the FACT-G GP5 will be used to assess the global impact of side effects. This endpoint will be assessed for Part 1 (dose optimization, independent and controlled experimental substudies) and Part 2 (expansion, independent and controlled experimental substudies). |
| Secondary | Estimate/Confirm established clinically meaningful change scores for clinical outcome assessments (COAs)/domain scores using the Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC) scales | On Day1 Cycle 1, then every 2 cycles for the first year; then every 3 cycles thereafter, at end of treatment and at first follow-up visit. The cycle is 28 days. | Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC) scales will be utilized as anchors to estimate/confirm established clinically meaningful change scores for clinical outcome assessments (COAs)/domain scores. This endpoint will be assessed for Part 1 (dose optimization, independent and controlled experimental substudies) and Part 2 (expansion, independent and controlled experimental substudies). |
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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