Trial · NCT06892522
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 (AE)s | Up to Approximately 130 Months | An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. |
| Primary | Substudy 1: Dose-Limiting Toxicity (DLT) of Etentamig + Daratumumab and Lenalidomide (DR) in Participants with Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TI NDMM) | Up to Approximately 8 weeks | DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications. |
| Primary | Substudy 2: DLT of Etentamig Monotherapy as Maintenance in Participants with Transplant-Eligible Newly Diagnosed Multiple Myeloma (TE NDMM) | Up to Approximately 8 Weeks | DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications. |
| Primary | Substudy 3: DLT of Etentamig +Carfilzomib and Dexamethasone (Kd) Combination in Participants with Relapsed or Refractory Multiple Myeloma (RR MM) | Up to Approximately 8 Weeks | DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications. |
| Primary | Substudy 4: DLT of Etentamig plus Lenalidomide when Given as Maintenance in Participants with TE NDMM | Up to Approximately 8 Weeks | DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications. |
| Primary | Substudy 5: DLT of ABBV-2001 in Combination with Iberdomide in Participants with RR MM | Up to Approximately 8 Weeks | DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications. |
| Primary | Substudy 6: DLT of ABBV-2001 in Combination with Mezigdomide in Participants with RR MM | Up to Approximately 8 Weeks | DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications. |
| Primary | Substudy 7: DLT of ABBV-2001 in Combination with Pomalidomide in Participants with RR MM | Up to Approximately 8 Weeks | DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications. |
| Primary | Substudy 8: DLT of ABBV-2001 in Combination with Lenalidomide in Participants with RR MM | Up to Approximately 8 Weeks | DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications. |
| Secondary | Substudy 1, 2, 3, 4, 5, 6, 7, 8: Complete Response Rate | Up to Approximately 1 Year | Complete response rate is defined as complete response (CR), stringent complete response (sCR) as assessed by the international myeloma working group (IMWG) 2016 criteria for MM. |
| Secondary | Substudy 1, 2, 3, 4, 5, 6, 7, 8: Overall Response Rate (ORR) | Up to Approximately 1 Year | The ORR is defined as the percentage of participants who achieve a best overall response of confirmed PR or better determined by IMWG criteria, prior to the initiation of subsequent myeloma therapy. |
| Secondary | Substudy 1, 2, 3, 4, 5, 6, 7, 8: Progression Free Survival (PFS) | Up to Approximately 130 Months | PFS is defined as the number of days from the date of first dose to the date of earliest disease progression (determined by the IMWG) or death. |
| Secondary | Substudy 1, 2, 3, 4, 5, 6, 7, 8: Duration of Response (DOR) | Up to Approximately 130 Months | DOR is defined as the time from the date of first response to the earliest occurrence of progressive disease, or death, whatever occurs first. |
| Secondary | Substudy 1, 2, 3, 4, 5, 6, 7, 8: Time-to-Progression (TTP) | Up to Approximately 130 Months | TTP will be defined as the number of days from the date of first dose to the date of earliest disease progression. |
| Secondary | Substudy 1, 2, 3, 4, 5, 6, 7, 8: Minimal Residual Disease (MRD) negativity | Up to Approximately 52 Weeks | The MRD negativity rate is defined as the proportion of participants who achieve MRD negative status. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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/NCT06892522/registered