Trial · NCT06896916
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Dose-Limiting Toxicities (DLT)s of Etentamig when given in Combination with Iberdomide in Participants with Relapsed/Refractory Multiple Myeloma (RRMM) | Up to Approximately 56 Days | 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 | Number of Participants with Adverse Events (AE)s | Up to Approximately 129 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. |
| Secondary | Partial Response (PR) Response Rate (RR) | Up to 3 Years | PR is defined \>= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90% or to \< 200 mg per 24 hours, if the serum and urine M-protein are unmeasurable, a \>= 50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, if the serum and urine M-protein are unmeasurable, and serum free light assay is also unmeasurable, a \>= 50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was \>= 30%, \>= 50% reduction in the size of soft tissue plasmacytomas is also required, if present at baseline. |
| Secondary | Very Good Partial Response (VGPR) RR | Up to 3 Years | VGPR is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>= 90% reduction in serum M-protein plus urine M-protein \< 100 mg per 24 hours, for participants in whom the only measurable disease is by serum free light chains (FLC) levels, VGPR is defined as \>= 90% decrease in the difference between involved and uninvolved FLC levels. |
| Secondary | Complete Response (CR) RR | Up to 3 Years | CR is defined negative immunofixation on the serum and urine (regardless of whether disease at baseline was measurable on serum, urine, both, or neither), disappearance of any soft tissue plasmacytomas, \< 5% plasma cells in bone marrow, and for participants in whom the only measurable disease is by serum FLC levels, a normal FLC ratio is also required. |
| Secondary | Stringent Complete Response (sCR) RR | Up to 3 Years | sCR is defined negative immunofixation on the serum and urine (regardless of whether disease at baseline was measurable on serum, urine, both, or neither), disappearance of any soft tissue plasmacytomas, \< 5% plasma cells in bone marrow, normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry (kappa/lambda ratio \<= 4:1 or \>= 1:2 for kappa and lambda participants, respectively, after counting \>= 100 plasma cells). |
| Secondary | Overall Response Rate (ORR) | Up to 3 Years | ORR (PR + VGPR + CR + sCR) will be defined as the proportion of participants who achieved a PR or better. |
| Secondary | Progression-Free Survival (PFS) | Up to 3 Years | PFS is defined as the number of days from the date of first dose to the date of earliest disease progression or death. |
| Secondary | Duration of Response (DOR) | Up to 3 Years | DOR is defined as the number of days from the date of first response (sCR, CR, VGPR, or PR) to the earliest recurrence, progressive disease, or death, whatever occurs first. |
| Secondary | Time-to-Progression (TTP) | Up to 3 Years | TTP will be defined as the number of days from the date of first dose to the date of earliest disease progression. |
| Secondary | Minimal Residual Disease (MRD) negativity | Up to 3 Years | The MRD negativity rate is defined as the proportion of participants who achieve MRD negative status. |
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/NCT06896916/registered