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Dara-VRd intensification, Dara-R maintenance · 1 trial · 1 indication
For the primary objective "for all patients" to describe the depth of response obtained with 6 cycles of Dara-VRd and the corresponding endpoint of MRD negativity at end of induction all patients with MRD evaluable
MRD \<10-5 assessed before and after 13 cycles of maintenance
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | 3 cycles of Dara-VRd intensification followed by 13 cycles of Dara-R maintenance in MRD negative patients |
| Arm B | ACTIVE_COMPARATOR | AHCT intensification followed by 13 cycles of Dara-R maintenance in MRD negative patients |
| Arm C | EXPERIMENTAL | AHCT intensification, 3 cycles of Dara-Tec consolidation and 13 cycles of Dara-Tec maintenance in MRD positive patients |
| Arm D | ACTIVE_COMPARATOR | AHCT intensification, 3 cycles of Dara-R consolidation and 13 cycles of Dara-R maintenance in MRD positive patients |
| Arm M | OTHER | Induction - 6 cycles of Dara-VRd in all participants |
| Name | Type | Description |
|---|---|---|
| Dara-VRd intensification, Dara-R maintenance | DRUG | Eligible patients are enrolled in arm M for induction therapy, corresponding to 6 cycles of Dara-VRd. Upon confirmation of adequate hematopoietic cell collection and result of MRD1 patients will undergo 1:1 randomization according to the MRD-assigned cohort • MRD negative cohort - Patients will be randomized between arm A (3 cycles of Dara-VRd intensification followed by 13 cycles of Dara-R maintenance) and arm B (AHCT intensification followed by 13 cycles of Dara-R maintenance) for intensification and maintenance |
| AHCT intensification, Dara-R maintenance | DRUG | Eligible patients are enrolled in arm M for induction therapy, corresponding to 6 cycles of Dara-VRd. Upon confirmation of adequate hematopoietic cell collection and result of MRD1 patients will undergo 1:1 randomization according to the MRD-assigned cohort • MRD negative cohort - Patients will be randomized between arm A (3 cycles of Dara-VRd intensification followed by 13 cycles of Dara-R maintenance) and arm B (AHCT intensification followed by 13 cycles of Dara-R maintenance) for intensification and maintenance |
| AHCT intensification, Tec-Dara consolidation, Tec-Dara maintenance | DRUG | Eligible patients are enrolled in arm M for induction therapy, corresponding to 6 cycles of Dara-VRd. Upon confirmation of adequate hematopoietic cell collection and result of MRD1 patients will undergo 1:1 randomization according to the MRD-assigned cohort. MRD positive cohort - Patients will be randomized between arm C (AHCT intensification, 3 cycles of Dara-Tec consolidation and 13 cycles of Dara-Tec maintenance) and arm D (AHCT intensification, 3 cycles of Dara-R consolidation and 13 cycles of Dara-R maintenance) for intensification, consolidation and maintenance. |
| AHCT intensification, Dara-R consolidation, Dara-R maintenance | DRUG | Eligible patients are enrolled in arm M for induction therapy, corresponding to 6 cycles of Dara-VRd. Upon confirmation of adequate hematopoietic cell collection and result of MRD1 patients will undergo 1:1 randomization according to the MRD-assigned cohort. MRD positive cohort - Patients will be randomized between arm C (AHCT intensification, 3 cycles of Dara-Tec consolidation and 13 cycles of Dara-Tec maintenance) and arm D (AHCT intensification, 3 cycles of Dara-R consolidation and 13 cycles of Dara-R maintenance) for intensification, consolidation and maintenance. |
| Dara-VRd induction | DRUG | Patients undergo induction therapy with 6 cycles of daratumumab, bortezomib, lenalidomide and dexamethasone |
Inclusion Criteria: 1. Age\>18 years with no upper age limit 2. Newly diagnosed multiple myeloma with indication for initiation of therapy. 3. ECOG performance status 0-2 4. No prior MM-directed therapy except for dexamethasone (up to 160 mg) and/or bortezomib (up to 5.2 mg/m2) and/or cyclophospham...
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Dara-VRd intensification, Dara-R maintenance is used for multiple myeloma. It is being studied as part of a sequential therapy approach guided by minimal residual disease (MRD) assessments. The regimen involves daratumumab-based intensification followed by daratumumab maintenance, and it is currently in Phase 2 clinical development.
Dara-VRd intensification, Dara-R maintenance is being developed by Johnson & Johnson (NYSE: JNJ). The company is conducting a Phase 2 clinical trial to evaluate this treatment approach in patients with multiple myeloma.
Dara-VRd intensification, Dara-R maintenance is in Phase 2 clinical development. It is an investigational regimen and has not been approved by regulatory authorities. The ongoing trial is actively recruiting participants with multiple myeloma.
Dara-VRd intensification, Dara-R maintenance is being evaluated in the clinical trial NCT05231629, titled "Sequential Therapy in Multiple Myeloma Guided by MRD Assessments." This Phase 2, randomized, active-controlled study is recruiting 300 participants in the United States.
Dara-VRd intensification, Dara-R maintenance is a treatment strategy that includes two phases: intensification with Dara-VRd (daratumumab, bortezomib, lenalidomide, and dexamethasone) followed by maintenance with Dara-R (daratumumab and lenalidomide). It is not a single drug but a sequential regimen.