A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (Dara-VCD) Induction Followed by Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients with Newly Diagnosed AL Amyloidosis
Categories (click each to see list of all clinical trials associated with that category): Myeloma/Plasma Cell Dyscrasia (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Holstein, Sarah
Eligibility: https://clinicaltrials.gov/study/NCT06022939?term=NCT06022939&rank=1
Summary
1.1. Primary Objective
a. To compare major organ deterioration progression-free survival between participants randomized to the ASCT and non-ASCT arms of this study.
1.2. Secondary Objectives
a. To compare overall survival (OS) between participants randomized to the ASCT and non-ASCT arms of this study.
b. To compare rates of cardiac and renal organ responses between participants randomized to the ASCT and non-ASCT arms of this study.
c. To compare rates of cardiac and renal organ progression between participants randomized to the ASCT and non-ASCT arms of the study.
d. To compare the frequency and severity of toxicities between participants randomized to the ASCT and non-ASCT arms of this study.
e. To compare minimal residual disease (MRD) negativity rates between participants randomized to the ASCT and non-ACST arms of this study.
1.3. Additional Objectives
a. To compare the best overall hematologic response rates between participants randomized to the ASCT and non-ASCT arms of this study.
b. To compare rates of hematologic complete response (CR) and very good partial response, following completion of consolidation therapy between participants randomized to the ASCT and non-ASCT arms of this study, post-consolidation.
c. To compare hematologic progression-free survival between participants randomized to the ASCT and non-ASCT arms of this study.
d. To compare time to next treatment between participants randomized to the ASCT and non-ASCT arms of the study.
e. To evaluate utilization of delayed ASCT in participants randomized to the non-ASCT arm of the study.
1.4. Translational Medicine Objectives
a. Primary:
1. To compare MRD negativity rates from bone marrow aspirates via next generation flow cytometry (NGF) between the ASCT and non-ASCT arms of this study post-consolidation.
2. To bank specimens for future use.
1.5. QOL Objectives
a. Primary:
1. To compare patient-reported physical function following consolidation treatment between participants randomized to the ASCT and non-ASCT arms using the PROMIS-29+2 Profile v2.1 physical function sub-scale.
1.6. PRO-CTCAE Objective
a. Primary
1. To compare patient reported symptoms regarding treatment emergent adverse events of interest using the Patient Reported Outcome CTCAE (PRO-CTCAE) Measurement System between patients randomized to the ASCT and non-ASCT arms of this study.