Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05572515 | A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma | PHASE3 | ACTIVE NOT_RECRUITING | 614 | — | — | Mar 29, 2023 | Aug 31, 2031 | Apr 13, 2026 | 211 | United States, Australia +22 |
| NCT06425991 | A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma | PHASE1 | ACTIVE NOT_RECRUITING | 108 | — | — | Jun 7, 2024 | Mar 3, 2027 | Apr 13, 2026 | 53 | United States, Australia +9 |
PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the International myeloma working group (IMWG) 2016 response criteria, or death due to any cause, whichever occurs first.
Severity for CRS will be graded as follows: Grade 1: Fever (Temperature greater than or equal to \[\>=\] 38°C); Grade 2: Fever (Temperature \>=38°C) with either: hypotension and/or hypoxia requiring low-flow nasal cannula or blow-by; Grade 3: Fever (Temperature \>=38°C) with either: hypotension and/or hypoxia requiring high-flow nasal cannula, facemask, nonrebreather mask, or Venturi mask; Grade 4: Fever (Temperature \>=38°C) with either: hypotension requiring multiple vasopressors (excluding vasopressin), and/or hypoxia requiring positive pressure and Grade 5: Death.
Cmax is defined as the maximum observed serum concentration of teclistamab (after first treatment dose).
AUCtau is defined as area under the concentration-time curve during dosing interval of teclistamab (after first treatment dose).
Ctrough is defined as observed serum concentration immediately prior to the next study treatment administration.
| Arm | Type | Description |
|---|---|---|
| Teclistamab | EXPERIMENTAL | Participants will receive teclistamab monotherapy in Part 1 and an alternative dosing regimen of teclistamab in Part 2. |
| Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd) | EXPERIMENTAL | Participants will receive either PVd or Kd based on principal investigator's choice during Part 1 of the study. |
| Arm A: Pre-change Teclistamab | EXPERIMENTAL | Participants will receive teclistamab monotherapy (made from the pre-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first. |
| Arm B: Post-change Teclistamab | EXPERIMENTAL | Participants will receive teclistamab monotherapy (made from the post-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first. |
| Name | Type | Description |
|---|---|---|
| Teclistamab | DRUG | Teclistamab will be administered subcutaneously. |
| Pomalidomide | DRUG | Pomalidomide will be administered orally. |
| Bortezomib | DRUG | Bortezomib will be administered subcutaneously. |
| Dexamethasone | DRUG | Dexamethasone will be administered orally in PVd and intravenously or orally in Kd. |
| Carfilzomib | DRUG | Carfilzomib will be administered intravenously. |
Inclusion Criteria: * Documented diagnosis of multiple myeloma as defined by the criteria below: (a)Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of the following: (1) Serum M-protein leve...