Trial · NCT06055075
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 Effects (AEs) | From initiation of study treatment up to approximately 15.7 months | AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
| Primary | Number of Participants With Cytokine Release Syndrome (CRS), With Severity Determined According to American Society of Transplantation and Cellular Therapy (ASTCT) Consensus Grading | From initiation of study treatment up to approximately 15.7 months | CRS=supraphysiologic response following administration of any immune therapy that results in activation/engagement of endogenous or infused T cells and/or other immune effector cells. Symptoms may be progressive, including fever at onset, headache, and myalgia and may also include hypotension, capillary leak (hypoxia), dyspnea, chest discomfort and end-organ dysfunction. Severity of CRS was determined per ASTCT Consensus Grading Criteria, which categorizes CRS into 5 grades- Grade 1: Fever (≥38◦Celsius), with/without constitutional symptoms, in absence of hypotension \& hypoxia; Grade 2: Fever with hypotension not requiring vasopressors and/or hypoxia requiring low-flow oxygen; Grade 3: Fever with hypotension requiring one vasopressor, with/without vasopressin, and/or hypoxia requiring high-flow oxygen; Grade 4: Fever accompanied by hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring positive-pressure ventilation; Grade 5: death due to CRS. |
| Primary | Number of Participants With Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), With Severity Determined According to ASTCT Consensus Grading | From initiation of study treatment up to approximately 15.7 months | ICANS grade is determined by the most severe event (immune effector cell-associated encephalopathy \[ICE\] score, level of consciousness, seizures, motor findings, raised intracranial pressure \[ICP\]/cerebral edema) not attributed to any other cause. Grade 1=ICE score of 7-9; awakens spontaneously; no seizure/motor findings/elevated ICP/cerebral edema. Grade 2=ICE score of 3-6; awakes voice; no seizure/motor findings/elevated ICP/cerebral edema. Grade 3=ICE score of 0-2; awakes only to tactile stimulus; any clinical seizure focal or generalized that resolves rapidly or nonconvulsive seizure on EEG that resolves with intervention; no motor findings; focal/local edema on neuroimaging. |
| Primary | Investigator-assessed Objective Response Rate (ORR) Per International Myeloma Working Group (IMWG) Response Criteria | Up to approximately 15.2 months | ORR=percentage of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per IMWG response criteria. CR \& sCR are defined as outlined in endpoint 5 (CRR/sCRR). VGPR=serum \& urine M-protein (UMP) detectable by immunofixation, but not electrophoresis; ≥90% reduction in serum M-protein (SMP) + UMP level \<100 mg/24 hrs; at baseline ≥90% reduction in sum of the maximal perpendicular diameter (SPD) compared with baseline for soft tissue plasmacytoma \& ≥90% decrease in the difference between involved \& uninvolved SFLC levels. PR=≥50% reduction in SMP \& UMP reduction ≥90% or \<200 mg/24hours; if SMP \& UMP not measurable, ≥50% decrease in involved \& uninvolved SFLC difference in place of M-protein criteria; if SMP, UMP \& SFLC assay not unmeasurable, ≥50% reduction in plasma cells required in place of M-protein (baseline BM plasma cell ≥30%); at baseline, a ≥50% reduction in SPD of soft tissue plasmacytomas. |
| Primary | Investigator-assessed Complete Response Rate (CRR) / Stringent Complete Response Rate (sCRR) Per IMWG Response Criteria | Up to approximately 15.2 months | CRR and sCRR were defined as the percentage of participants with CR or sCR, as determined by the investigator per IMWG response criteria. CR was defined as: no evidence of initial monoclonal protein isotype(s) on immunofixation of the serum \& urine; Disappearance of any soft tissue plasmacytomas; \<5% plasma cells in BM \& a normal SFLC ratio of 0.26-1.65. sCR was defined as: CR (defined above); normal SFLC ratio, \& absence of clonal cells in BM by IHC or negative by 2-4 color flow cytometry. CR and sCR are distinct response categories and are evaluated and reported separately in accordance with the defined response criteria i.e., if a response is clinically upgraded from CR to sCR it is not further considered a CR but solely a sCR. Percentages have been rounded off. |
| Primary | Investigator-assessed VGPR Rate or Better Per IMWG Response Criteria | Up to approximately 15.2 months | VGPR rate was defined as the percentage of participants with VGPR as determined by the investigator per IMWG response criteria. VGPR was defined as: serum \& UMP detectable by immunofixation, but not on electrophoresis; or ≥90% reduction in SMP plus UMP level \<100 mg/24 hours; at baseline ≥90% reduction in SPD compared with baseline for soft tissue plasmacytoma \& ≥90% decrease in the difference between involved \& uninvolved SFLC levels. Responses better than VGPR include CR and sCR (as defined in endpoint 5). Percentages have been rounded off. |
| Secondary | Investigator-assessed Progression-free Survival (PFS) Per IMWG Response Criteria | Up to approximately 15.2 months | PFS=time from randomization until disease progression (PD) per IMWG criteria or death from any cause. PD=any 1 or more of the following: Increase of 25% from lowest response value in any of the following: Serum M-component, Urine M-component or in participants without measurable SMP \& UMP levels: difference between involved \& uninvolved FLC levels; For non-secretory participants at study entry: in participants without measurable SMP \& UMP levels \& without measurable disease by FLC: BM plasma cell percentage irrespective of baseline status (absolute %must be ≥10%); appearance of a new lesion/s, ≥ 50% increase from nadir in SPD of \>1 lesion, or ≥50% increase in the longest diameter of a previous lesion \>1centimeters (cm) in short axis; Definite development of new bone lesions/definite increase in the size of existing bone lesions; ≥50% increase in circulating plasma cells. Kaplan-Meier (K-M) method was used to estimate the median PFS. Overall number analyzed=participants with an event. |
| Secondary | Investigator-assessed Duration of Response (DoR) for Participants Who Achieved PR or Better | Up to approximately 15.2 months | DoR was defined as the time from the initial objective response (OR) (sCR, CR, PR, or VGPR) to the time of PD or death from any cause as determined by the investigator per IMWG response criteria. CR, sCR, VGPR, and PR were defined the same as outlined in the description for the primary endpoint ORR. PD was defined as outlined in the description for the endpoint PFS. K-M method was used to estimate the median DOR. |
| Secondary | Investigator-assessed Time to Response (TTR) Per IMWG Response Criteria | Up to approximately 15.2 months | TTR was defined as the time from randomization until an OR (PR or better), as determined by the investigator per IMWG response criteria. CR, sCR, VGPR and PR were defined the same as outlined in the description for the primary endpoint ORR. K-M method was used to estimate the median TTR. |
| Secondary | Investigator-assessed Time to Best Response (TTBR) Per IMWG Response Criteria | Up to approximately 15.2 months | TTBR was defined as the time from randomization until the best OR (sCR, CR, VGPR, or PR), as determined by the investigator per IMWG response criteria. CR, sCR, VGPR and PR were defined the same as outlined in the description for the primary endpoint ORR. K-M method was used to estimate the median TTBR. |
| Secondary | Investigator-assessed Overall Survival (OS) | Up to approximately 15.7 months | OS was defined as the time from randomization to death from any cause as determined by the investigator per IMWG response criteria. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. K-M method was used to estimate the median OS. |
| Secondary | Number of Participants With Anti-drug Antibodies (ADAs) to Forimtamig | Up to approximately 15.7 months | Participants who received forimtamig were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following forimtamig exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants with a positive post-baseline sample have been reported here. |
| Secondary | Serum Concentrations of Forimtamig at the Specified Timepoints | Pre-dose on Day (D)1 of Cycle (C)1,2&4, D4 of C1&5, D2C3; 4hours post-dose on D1,4 of C1, D2C3, D1C4, D4C5; D2,8,9,11,15,16&18 of C1; D2,8,15,22 of C2&4; D1,4,8,15,22 of C3; D1,8,15 of C5; D1,4,8,15 of C6,7,8&9; D1,4,8 of C10 | |
| Secondary | Area Under the Concentration-time Curve From Dosing to the Time of the Last Measured Concentration (AUClast) of Forimtamig | Up to Day 15 of Cycle 3 (1 cycle=28 days) | |
| Secondary | Maximum Observed Concentration (Cmax) of Forimtamig | Day 1 of Cycle 3 (1 cycle=28 days) |
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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