Trial · NCT05145400
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 | Overall Response Rate (ORR) | From Day 1 of study treatment up to 60 months | ORR, percentage of patients achieving a partial response or better per Revised Uniform Response Criteria by the International Myeloma Working Group (IMWG) criteria. Complete response (CR): Negative immunofixation of serum and urine, disappearance of soft tissue plasmacytomas, and \<5% plasma cells in bone marrow (BM). Stringent complete response (sCR): CR plus normal free light chains (FLC) ratio and absence of clonal plasma cells in BM biopsy. Very good partial response (VGPR):-Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M component plus urine M component \<100/24h. Partial response (PR) ≥50% reduction of serum M-protein \& reduction in 24-hour (24h) urinary M-protein by ≥90% or to \<200 mg/24h and if present at baseline, a ≥ 50% reduction in the size soft tissue plasmacytomas |
| Secondary | Treatment failure-free survival (TFFS) Time | From Day 1 of study treatment up to 60 months | Treatment failure-free survival (TFFS): The length of time from therapy start until therapy discontinuation for any reason, including disease progression, toxicity, or death. |
| Secondary | Progression-Free Survival (PFS) | From Day 1 of study treatment up to 60 months | PFS is the length of time from start of study treatment until day of confirmed progression or death. The (IMWG) defines progression as any one or more: Increase of 25% from lowest response value in Serum M-protein (absolute increase (AI) ≥ 0.5 g/dL); Serum M-protein increase ≥ 1 g/dL, if lowest M component was ≥ 5 g/dL; or Urine M-protein Difference of involved \& uninvolved FLC (free light chain) levels (AI \> 10 mg/dL) Bone marrow plasma cell percentage irrespective of baseline status (AI ≥ 10%) New lesion(s), ≥ 50% increase from nadir, or ≥ 50% increase in longest diameter of previous lesion \>1 cm in short axis; ≥ 50% increase in circulating plasma cells if only measure of disease New or definite increase in size of existing soft tissue plasmacytomas or bone lesions; Decrease in hemoglobin of ≥ 2 g/dL not related to therapy; Rise in serum creatinine by ≥2 mg/dL; Hyperviscosity related to serum paraprotein |
| Secondary | Maximum Depth of Response | From Day 1 of study treatment up to 60 months | Maximum depth of response (from PR to CR, including sCR) at any time will be determined based on IMWG criteria. Descriptions of partial, complete, or stringent-complete type treatment responses are summarized in the primary outcome section. |
| Secondary | Rate of achievement of bone marrow minimal residual disease (MRD) negativity | From Day 1 of study treatment up to 60 months | MRD status is determined by next-generation sequencing with a minimum sensitivity of 1 × 10-5. MRD refers to myeloma cells that are present in the bone marrow after a clinical response has been measured while signs and symptoms of MM are reduced or disappeared. |
| Secondary | Clinical Benefit Rate (minimal response (MR) + ORR) | From Day 1 of study treatment up to 60 months | The clinical benefit rate is the percentage of participants achieving overall response or minimal response. Description of overall response as defined as the percentage of subjects achieving a partial response or better (≥ PR) to study therapy at any time. Minimal response (MR) is ≥ 25% but ≤ 49% reduction of serum M-protein and reduction in 24-h urine M-protein by 50-89%. In addition to the above listed criteria, if present at baseline, a ≥ 50% reduction in the size (SPD) of soft tissue plasmacytomas is also required. |
| Secondary | Time to Response | From Day 1 of study treatment up to 60 months | Time to response is the length of time from start of study treatment until documentation of confirmed partial response (PR) or better based on IMWG criteria. Response description is given in the primary outcome section. |
| Secondary | Duration of Response | From Day 1 of study treatment up to 60 months | Duration of response is the length of time from achievement of PR or better until myeloma progression per IMWG criteria. PR description is given in the primary outcome section. |
| Secondary | Time to Next Treatment | From Day 1 of study treatment up to 60 months | Time to next treatment is the length of time time from start of study treatment to next MM treatment or death from any cause. |
| Secondary | Overall Survival | From Day 1 of study treatment up to 60 months | Overall Survival is the length of time from start of study treatment to death from any cause. |
| Secondary | Toxicity Rate | From Day 1 of study treatment up to 60 months | Toxicity rate is percentage of participants who experience treatment related Adverse Events (AE) as evaluated by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0. NCI-CTCAE is a descriptive terminology utilized for AE reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. |
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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