Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Daratumumab · 1 trial · 1 indication
ORR is defined as the percentage of participants with documented partial response (PR) or better based on International Myeloma Working Group (IMWG) criteria.
VGPR or better response rate is defined as the proportion of participants with documented VGPR or better (sCR, CR. or VGPR) based on IMWG criteria.
CR or better response is defined as the percentage of participants with documented response of CR or better (stringent complete response \[sCR\] or CR) based on IMWG criteria.
TTR is defined as the number of days from the date of treatment start (for subjects enrolled prior to randomization start) or randomization (for randomized subjects) to the date of first documented response of PR or better.
DOR is defined as the number of days from the participant's date of first documented response (PR or better) to the date of first documented disease progression or death due to multiple myeloma, whichever occurs first.
TTP is defined as the number of days from the date of treatment start (for subjects enrolled prior to randomization start) or randomization (for randomized subjects) to the date of first documented PD or death due to MM, whichever occurs first.
PFS is defined as the number of days from the date of treatment start (for subjects enrolled prior to randomization start) or randomization (for randomized subjects) to the date of the first documented PD or death due to any cause, whichever occurs first.
OS is defined as the number of days from the date of treatment start (for subjects enrolled prior to randomization start) or randomization (for randomized subjects) to the date of death.
| Arm | Type | Description |
|---|---|---|
| Arm A, Part 1a: VenDd Dose Escalation | EXPERIMENTAL | Venetoclax (Ven) various doses administered orally, once daily (QD) in combination with daratumumab (D) (1800 mg subcutaneous injection (preferred) or 16 mg/kg intravenous \[IV\]) administered in accordance with prescribing information and dexamethasone (d) (oral or IV) 40 mg weekly (or 20 mg weekly, if necessary, as described in the protocol). |
| Arm B, Part 1b: VenDd Dose Expansion | EXPERIMENTAL | Venetoclax at a dose determined by the dose-escalation phase, administered orally QD in combination with daratumumab (1800 mg subcutaneous injection (preferred) or 16 mg/kg IV) administered in accordance with prescribing information and dexamethasone (oral or IV) 40 mg weekly (or 20 mg weekly, if necessary, as described in the protocol). |
| Arm D, Part 2a: VenDVd Dose Escalation | EXPERIMENTAL | Venetoclax at various doses administered orally QD in combination with daratumumab (1800 mg subcutaneous injection (preferred) or 16 mg/kg IV) administered in accordance with prescribing information, bortezomib (1.3 mg/m2 subcutaneous injection \[preferred\] or IV) Cycles 1-8, Days 1, 4, 8 and 11), and dexamethasone (oral or IV) 20 mg Cycles 1 - 3, Days 1, 2, 4, 5, 8, 9, 11,12 and 15; 20 mg Cycles 4-8, Days 1,2,4,5,8,9,11 and 12; 40 mg weekly (or 20 mg weekly, if necessary as described in the protocol) Cycle 9+. |
| Arm E, Part 2b: VenDVd Dose Expansion | EXPERIMENTAL | Venetoclax at dose determined by the dose-escalation phase, administered orally QD in combination with daratumumab (1800 mg subcutaneous injection (preferred) or 16 mg/kg IV) administered in accordance with prescribing information, bortezomib (1.3 mg/m2 subcutaneous injection) Cycles 1-8, Days 1, 4, 8 and 11, and dexamethasone (oral or IV) 20 mg Cycles 1 - 3, Days 1, 2, 4, 5, 8, 9, 11,12 and 15; 20 mg Cycles 4-8, Days 1,2,4,5,8,9,11 and 12; 40 mg weekly (or 20 mg weekly, if necessary as described in the protocol) Cycle 9+. |
| Arm F: VenDd Dose Expansion | EXPERIMENTAL | Venetoclax at a pre-determined dose, administered orally QD in combination with daratumumab (1800 mg subcutaneous injection (preferred) or 16 mg/kg IV) administered in accordance with prescribing information and dexamethasone (oral or IV) 40 mg weekly (or 20 mg weekly, if necessary, as described in the protocol). |
| Arm G: VenDd Dose Expansion | EXPERIMENTAL | Venetoclax at a pre-determined dose, administered orally QD in combination with daratumumab (1800 mg subcutaneous injection (preferred) or 16 mg/kg IV) administered in accordance with prescribing information and dexamethasone (oral or IV) 40 mg weekly (or 20 mg weekly, if necessary, as described in the protocol). |
| Arm H: DVd Dose | ACTIVE_COMPARATOR | Daratumumab (1800 mg subcutaneous injection (preferred) or 16 mg/kg IV) administered in accordance with prescribing information, bortezomib (1.3 mg/m2 subcutaneous injection) Cycles 1-8: Days 1, 4, 8 and 11, and dexamethasone (oral or IV) 20 mg on Cycles 1 - 3: Days 1, 2, 4, 5, 8, 9, 11,12 and 15; 40 mg weekly (or 20 mg weekly, if necessary as described in the protocol) on Cycles 4-8: Days 1,2,4,5,8,9,11 and 12; 20 mg monthly for Cycles 9+: Day 1 |
| Name | Type | Description |
|---|---|---|
| Dexamethasone | DRUG | Infusion; Intravenous (IV), or Tablet; Oral |
| Daratumumab | DRUG | Injection; Subcutaneous (preferred), Infusion; Intravenous (IV) |
| Venetoclax | DRUG | Tablet; Oral |
| Bortezomib | DRUG | Injection; Subcutaneous (preferred), Infusion; Intravenous (IV) |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status \<= 2. * Participant has relapsed or refractory multiple myeloma with documented evidence of progression that occurred during or after the participant's last treatment regimen based on investigator's determination of...
Top 20 of 25 competitors
Daratumumab is an investigational antibody being studied for the treatment of Multiple Myeloma. It is currently in Phase 2 clinical development as part of combination therapy regimens for patients with relapsed or refractory disease. The drug is being evaluated in a randomized, active-controlled trial.
Daratumumab is being developed by AbbVie Inc., which trades under the ticker ABBV. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Multiple Myeloma.
Daratumumab is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 2 trial is active but not recruiting participants, with a total enrollment of 156 patients.
Daratumumab is being studied in a Phase 2 clinical trial with the identifier NCT03314181. The trial is titled 'A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Participants With Relapsed or Refractory Multiple Myeloma.' The study is active but not recruiting and includes 156 participants.
Daratumumab is a monoclonal antibody, classified as a -mab (antibody) therapeutic. It is designed to target specific proteins involved in the disease process of Multiple Myeloma. The drug is being tested in combination with other agents to potentially enhance its therapeutic effect.
No, Daratumumab is not the same as Venetoclax. Daratumumab is a monoclonal antibody, while Venetoclax is a different drug. In the clinical trial NCT03314181, Daratumumab is being studied in combination with Venetoclax and dexamethasone, with or without bortezomib, for the treatment of relapsed or refractory Multiple Myeloma.