Sequential High-dose Dexamethasone and Response Adopted PAD or VAD Induction Chemotherapy Followed by High-dose Chemotherapy With Autologous Stem Cell Transplantation for Newly Diagnosed Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:
Sequential High-dose Dexamethasone and Response Adopted PAD (Bortezomib, Adriamycin, Dexamethasone) or VAD (Vincristine, Adriamycin, Dexamethasone) Induction Chemotherapy Followed by High-dose Chemotherapy With Autologous Stem Cell Transplantation for Newly Diagnosed Multiple Myeloma; Multicenter Phase 2 Study

Status Completed

Clinical Trial Summary

Complete Response (CR) plus near CR rate of VAD (Vincristine, Adriamycin, Dexamethasone) induction chemotherapy followed by ASCT in patients with newly diagnosed MM was about 50% and CR plus near CR rate of PAD (Bortezomib, Adriamycin, Dexamethasone) induction chemotherapy followed by ASCT in patients with newly diagnosed MM was about 60%. If the CR with near CR rate of sequential high-dose dexamethasone and response adopted PAD or VAD induction chemotherapy followed by ASCT is more than 60%, this combination will be accepted as active regimen that may be worth for investigating in phase III trial. But, if the CR with near CR rate of this regimen is lower than 50%, this has not a merit than VAD induction chemotherapy.

Based upon the above assumption, this trial was designed by using Simon's optimal two-stage testing procedure. Assuming a target level of interest, p1=0.6, and a lower activity level, p0=0.5. Initially 61 patients will be accrued. If 33 or more CR + near CR rate were observed, the trial will be continued. Accrual will be planned to a total of 190 patients. If total 106 or more patients were assessed as CR with near CR, sequential high-dose dexamethasone and response adopted PAD or VAD induction chemotherapy regimen will be accepted as active regimen. This design provides probability 0.05 of accepting drugs worse than p0 and probability 0.20 of rejecting drugs better than p1. If we assume that drop-out rate is 10%, total accrual patient will be 210.

Patient characteristics and toxicity will be evaluated by descriptive methods. Progression free survival and overall survival (median value, 95% confidence interval) will be calculated by Kaplan-Meier method.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01255514
Study type	Interventional
Source	Yonsei University
Contact
Status	Completed
Phase	Phase 2
Start date	October 30, 2008
Completion date	December 31, 2014

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05027594` - Ph I Study in Adult Patients With Relapsed or Refractory Multiple Myeloma	Phase 1
Completed	`NCT02412878` - Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma	Phase 3
Completed	`NCT01947140` - Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies	Phase 1/Phase 2
Recruiting	`NCT05971056` - Providing Cancer Care Closer to Home for Patients With Multiple Myeloma	N/A
Recruiting	`NCT05243797` - Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation	Phase 3
Active, not recruiting	`NCT04555551` - MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma	Phase 1
Recruiting	`NCT05618041` - The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies	N/A
Active, not recruiting	`NCT03844048` - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial	Phase 3
Recruiting	`NCT03412877` - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer	Phase 2
Completed	`NCT02916979` - Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG	Phase 1
Recruiting	`NCT03570983` - A Trial Comparing Single Agent Melphalan to Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) as a Preparative Regimen for Patients With Multiple Myeloma Undergoing High Dose Therapy Followed by Autologous Stem Cell Reinfusion	Phase 2
Completed	`NCT03665155` - First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody	Phase 1/Phase 2
Terminated	`NCT03399448` - NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells)	Phase 1
Completed	`NCT02812706` - Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients	Phase 1/Phase 2
Active, not recruiting	`NCT05024045` - Study of Oral LOXO-338 in Patients With Advanced Blood Cancers	Phase 1
Active, not recruiting	`NCT03989414` - A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)	Phase 1/Phase 2
Active, not recruiting	`NCT03792763` - Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients	Phase 2
Withdrawn	`NCT03608501` - A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation	Phase 2
Recruiting	`NCT04537442` - Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma	Phase 1
Completed	`NCT02546167` - CART-BCMA Cells for Multiple Myeloma	Phase 1