Trial · NCT05469893
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response Rate (CRR) | Cycle 2 Day 1 through end of follow up (each cycle is 28 days). | The complete response rate (CRR) was defined as the proportion of participants achieving complete response (CR) based on International Myeloma Working Group (IMWG) Response criteria. CR defined as requires all of the following: * Disappearance of the original monoclonal protein from the blood and urine on at least two determinations for a minimum of six weeks by immunofixation studies. * \<5% plasma cells in the bone marrow on at least two determinations for a minimum of six weeks. * No increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response). * Disappearance of soft tissue plasmacytomas for at least six weeks. |
| Secondary | Minimal Residual Disease (MRD) Negativity | Baseline, Cycle 6 Day 1, Cycle 13 Day 1, end of treatment, 1, 2, & 3 year after end of treatment (each cycle is 28 day). | The MRD is expressed as a frequency that quantifies the level of residual disease based on the number of remaining copies of the initially dominant sequence(s) relative to the total number of nucleated cells in the sample. |
| Secondary | Progression-free survival (PFS) until progression to myeloma | Every 6 months, up to 3 years after treatment discontinuation. | Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. International Myeloma Working Group (IMWG) Response criteria: Progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. |
| Secondary | Progression-free survival (PFS-2) post initiation of overt myeloma therapy | Every 6 months, up to 3 years after treatment discontinuation. | Progression-free survivial-2 is defined as time from randomization to disease progression (PD) while receiving overt myeloma therapy, or death from any cause. |
| Secondary | Time to progression | Cycle 2 Day1 through end of follow up, an average of 5 years (each cycle is 28 days). | Time to progression (TTP) is defined as the time of randomization until progression. Participants who have died without evidence of progression are censored in the TTP analysis at the time of death and participants who are alive without progression are censored at the last disease assessment. |
| Secondary | Duration of Response (DOR) | Cycle 2 Day1 through end of follow up, an average of 5 years (each cycle is 28 days). | The duration of overall response is measured as the time from initiation of first response to first documentation of disease progression or death whichever occurs first. Participants who have not progressed or died are censored at the date last known progression-free. |
| Secondary | Pharmacodynamic biomarkers of antimyeloma and immune activity of Teclistamab | Cycle 1 Days 1, 8, 9, 11, 15; Cycle 2 Day 1; Cycle 3 & 5 Days 1, 4, 8, and 15; Cycle 12 Day 1; End of treatment; and 8 week after last dose of Teclistamab (each cycle is 28 day). | Serum from venous blood samples will be collected for measurement of serum concentrations of teclistamab (Arm A - Teclistamab only) and the generation of Anti-drug Antibodies (ADAs) where applicable to teclistamab per the Study Schedule. |
| Secondary | Pharmacokinetics of teclistamab in SMM | Cycle 1 Days 1, 8, 9, 11, 15; Cycle 2 Day 1; Cycle 3 & 5 Days 1, 4, 8, and 15; Cycle 12 Day 1; End of treatment; and 8 week after last dose of Teclistamab (each cycle is 28 day). | Serum from venous blood samples will be collected for measurement of serum concentrations of teclistamab (Arm A - Teclistamab only) and the generation of Anti-drug Antibodies (ADAs) where applicable to teclistamab per the Study Schedule. |
| Secondary | Immunogenicity of Teclistamab in SMM | Cycle 1 Days 1, 15; Cycle 3 & 5 Days 1, 4, 8, and 15; and Cycle 12 Day 1 (each cycle is 28 day) | Serum from venous blood samples will be collected for measurement of serum concentrations of teclistamab (Arm A - Teclistamab only) and the generation of Anti-drug Antibodies (ADAs) where applicable to teclistamab per the Study Schedule. |
| Secondary | To assess ability to collect stem cells after Teclistamab | After 4 cycles of treatment; at the time of best response; or at the investigator's discretion as part of standard of care practice.(each cycle is 28 days) | Stem cell mobilization will be performed with filgrastim alone or filgrastim with plerixafor per institutional standard. In participants that are unable to achieve adequate stem cell yield with filgrastim and plerixafor, cyclophosphamide may be used per institutional standard. |
| Secondary | To assess Overall Survival (OS) | Every 6 months up to 3 years after treatment discontinuation. | OS based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive. |
| Secondary | To assess incidence of Treatment-Emergent Adverse Events that are assessed by the number of patients experiencing at least one treatment-related grade 3 or higher AE of any type during the time of observation | Baseline through end of post-treatment follow up period, an average of 5 years | All grade 3 or higher adverse events (AE) with treatment attribution of possibly, probably or definite based on Common Terminology Criteria for Adverse Event - Version 5 (CTCAEv5) as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade 3 or higher AE of any type during the time of observation. |
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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