Trial · NCT04392648
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants who Experienced at Least one Treatment Emergent Adverse Event (TEAE) | Dose Escalation Phase: up to Cycle 17 (Cycle length = 21 days in Arm 1 and is = 28 days in Arms 2 and 3); Dose Expansion Phase: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6) | |
| Primary | Number of Participants with Clinically Significant Vital Signs Values, Clinically Significant Change From Baseline in Clinical Laboratory Values and 12-lead Electrocardiograms (ECG), and who Received any Concomitant Medications | Dose Escalation Phase: up to Cycle 17 (Cycle length = 21 days in Arm 1 and is = 28 days in Arms 2 and 3); Dose Expansion Phase: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6) | |
| Primary | Dose Expansion Phase: Overall Response Rate (ORR) | Cycle 17 up to 3 years (Cycle length is equal to [=] 21 days in Arm 4 and is = 28 days in Arms 5 and 6) | ORR is defined as the percentage of participants who achieved confirmed partial response (PR) or better during the study as assessed with International Myeloma Working Group (IMWG) Uniform Response Criteria. PR: greater than or equal to (\>=) 50 percent (%) reduction of serum M protein and \>=90% reduction in urine M-protein or less than (\<) 200 milligram per 24 hour (mg/24 hour), or \>=50% decrease in uninvolved free light chain (FLC). At baseline, a \>=50% decrease in size of soft tissue plasmacytomas is required. |
| Secondary | Dose Escalation Phase, Cmax: Maximum Observed Serum Concentration for TAK-573 | Cycles 1 and 2 Day 1: pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3) | |
| Secondary | Dose Escalation Phase, Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAK-573 | Cycles 1 and 2 Day 1: pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3) | |
| Secondary | Dose Escalation Phase, AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-573 | Cycles 1 and 2 Day 1: pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3) | |
| Secondary | Dose Escalation Phase, AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-573 | Cycles 1 and 2 Day 1: pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3) | |
| Secondary | Dose Escalation Phase, Lambda (λ) z: Apparent Serum Terminal Disposition Rate Constant for TAK-573 | Cycles 1 and 2 Day 1: pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3) | |
| Secondary | Dose Escalation Phase, T1/2z: Apparent Serum Terminal Elimination Phase Half-life for TAK-573 | Cycles 1 and 2 Day 1: pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3) | |
| Secondary | Dose Escalation Phase, CL: Total Clearance After Administration for TAK-573 | Cycles 1 and 2 Day 1: pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3) | |
| Secondary | Dose Escalation Phase, Vss: Volume of Distribution at Steady State After Administration for TAK-573 | Cycles 1 and 2 Day 1: pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3) | |
| Secondary | Percentage of Participants with Positive Antidrug Antibodies (ADA) for Anti-573 | Dose Escalation Phase: up to Cycle 17 (Cycle length = 21 days in Arm 1 and is = 28 days in Arms 2 and 3); Dose Expansion Phase: Cycle 17 up to 3 years (Cycle length is = 21 days in Arm 4 and = 28 days in Arms 5 and 6) | |
| Secondary | Dose Escalation Phase: ORR | Up to Cycle 17 (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3) | ORR is defined as the percentage of participants who achieved confirmed PR or better during the study as assessed with IMWG Uniform Response Criteria. PR: \>= 50% reduction of serum M protein and \>=90% reduction in urine M-protein or \<200 mg/24 hour, or \>=50% decrease in uninvolved FLC. At baseline, a \>=50% decrease in size of soft tissue plasmacytomas is required. |
| Secondary | Best Overall Response (BOR) | Dose Escalation Phase: up to Cycle 17 (Cycle length = 21 days in Arm 1 and is = 28 days in Arms 2 and 3); Dose Expansion Phase: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6) | BOR is defined as the best response recorded after the first dose of any study drug until subsequent therapy for multiple myeloma (MM). BOR will be assessed as per IMWG uniform response criteria. |
| Secondary | Clinical Benefit Rate (CBR) | Dose Escalation Phase: up to Cycle 17 (Cycle length = 21 days in Arm 1 and is = 28 days in Arms 2 and 3); Dose Expansion Phase: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6) | The CBR is defined as the percentage of participants who achieved an ORR along with the minimal response (MR) or better during the study as assessed with IMWG Uniform Response Criteria. ORR is defined as the percentage of participants who achieved confirmed PR or better during the study as assessed with IMWG Uniform Response Criteria. MR is defined as a \>=25% but less than or equal to (\<=) 49% reduction of serum M protein and reduction in 24-hour urine M protein by 50% to 89%. In addition, if present at baseline, 25% to 49% reduction in size of soft tissue plasmacytomas is also required. No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response). |
| Secondary | Disease Control Rate (DCR) | Dose Escalation Phase: up to Cycle 17 (Cycle length = 21 days in Arm 1 and is = 28 days in Arms 2 and 3); Dose Expansion Phase: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6) | The DCR is defined as the percentage of participants who achieved CBR along with a stable disease (SD) or better during the study as assessed with IMWG Uniform Response Criteria. The CBR is defined as the percentage of participants who achieved an ORR along with the minimal response (MR) or better during the study as assessed with IMWG Uniform Response Criteria. SD is defined as no known evidence of progressive or new bone lesions. |
| Secondary | Median Duration of Response (DOR) | Dose Escalation Phase: up to Cycle 17 (Cycle length = 21 days in Arm 1 and is = 28 days in Arms 2 and 3); Dose Expansion Phase: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6) | DOR: number of days from first documentation of a confirmed response until progressive disease (PD) or until last adequate response assessment if there is no PD. DOR will be assessed as per IMWG uniform response criteria. PD: increase of 25% from lowest response value in any one or more of the following: serum M protein and/or; urine M component and/or; only in participants without measurable serum and urine M protein levels; the difference between involved and uninvolved FLC levels (absolute increase \>10 milligram per deciliter \[mg/dL\]); Bone marrow plasma cell percentage (absolute percentage must be \>10%); definite development of new bone lesions or soft tissue plasmacytomas or increase in the size of existing bone lesions/soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder. |
| Secondary | Dose Expansion Phase: Progression Free Survival (PFS) | Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6) | PFS: time from date of first dose until sooner of the date of PD, defined by IMWG criteria, or the date of death due to any cause, whichever occurs first. PD: increase of 25% from lowest response value in any one or more of the following: serum M protein and/or; urine M component and/or; only in participants without measurable serum and urine M protein levels; the difference between involved and uninvolved FLC levels (absolute increase \>10 mg/dL); Bone marrow plasma cell percentage (absolute percentage must be \>10%); definite development of new bone lesions or soft tissue plasmacytomas or increase in the size of existing bone lesions/soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder. |
| Secondary | Dose Expansion Phase: Time to Response (TTR) | Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6) | TTR is defined as the time from first dose to the date of first documentation of response (PR or better). PR: A \>=50% reduction of serum M protein and \>=90% reduction in urine M-protein or \<200 mg/24 hour, or \>=50% decrease in uninvolved FLC. A \>=50% decrease in size of soft tissue plasmacytomas present at baseline. The Kaplan-Meier method will be used to estimate the distribution of TTR for dose level and group with at least 10 participants in the safety analysis set. |
| Secondary | Dose Expansion Phase: Overall Survival (OS) | Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6) | OS is defined as the time elapsed between the date of diagnosis until death, with censoring of participants who are alive when last seen or who are lost to follow up. |
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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GET https://conductscience.org/api/trials/v1/NCT04392648/registered