Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment for Newly Diagnosed Multiple Myeloma (MM) With Upfront Daratumumab-based Therapy
| Заболевание | Multiple Myeloma |
|---|---|
| Фаза | Фаза 2 |
| Спонсор | University of Michigan Rogel Cancer Center |
| Статус | Идёт, набор закрыт |
| Участники | 57 участн. |
| Вмешательство | Daratumumab, Lenalidomide, Bortezomib, Dexamethasone |
| Дата начала | 5.10.2020 |
| Дата завершения | 2.05.2024 |
| Публикация результатов | 28.07.2026 |
Кратко
This phase 2 trial will test whether the combination of DaraRd (daratumumab + lenalidomide + dexamethasone) as induction therapy, followed by DRVd (daratumumab + lenalidomide + bortezomib + dexamethasone) consolidation therapy, if needed, will result in more patients achieving minimal residual disease (MRD)-negative status, relative to the standard of care. Consolidation therapy will be administered only to those patients with MRD-positive status after induction therapy. This is a study based on adaptive design for decision making of treatment options. Duration of therapy (daratumumab cycles) will depend on individual approach, response, evidence of disease progression and tolerance.
Proportion of Participants Who Achieve MRD Negativity Either After Induction or, if Still MRD-positive After Induction, After Consolidation.
| Dara-Rd Followed by Dara-RVd | 15 Participants |
|---|
Открыть в BENITIONS Открыть на ClinicalTrials.gov
Другие исследования по этому заболеванию
- Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Mu — National Cancer Institute (NCI)
- Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Tr — National Cancer Institute (NCI)
- Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previo — National Cancer Institute (NCI)
- Study to Evaluate the Role of Siltuximab in Treatment of Cytokine Release Syndrome (CRS) a — University of Alabama at Birmingham
- Pembrolizumab in Treating Patients With Intermediate or High-Risk Smoldering Multiple Myel — M.D. Anderson Cancer Center
- Testing Afatinib as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (M — National Cancer Institute (NCI)