Autologous Transplantation for Multiple Myeloma

Status Completed

Clinical Trial Summary

The present study was designed in an attempt to prospectively evaluate in a randomized fashion whether further cytotoxic dose intensification, as delivered with two sequential autologous stem-cell transplantations, improved the outcome of younger patients with newly diagnosed multiple myeloma in comparison with a single autologous transplantation.

Clinical Trial Description

Following demonstration that single autologous transplantation for the treatment of younger patients with newly diagnosed multiple myeloma prolonged overall survival in comparison with conventional chemotherapy, double autologous transplantation was tested, initially in refractory myeloma and subsequently to include also patients with newly diagnosed disease. To explore the role of double autologous stem-cell transplantation as part of up-front therapy for multiple myeloma, in 1996 we launched a prospective, randomized trial comparing a single course of stem-cell-supported melphalan with the same regimen followed, after three to six months, by a second autologous transplantation in support of melphalan and busulfan. The study was designed to detect a 15 percent increase in complete or near complete response rate with double transplants compared to a single transplantation. With a 2-sided significance level α = 0.05 and a power 1-β = 0.80, 162 patients were required in each treatment arm of the study to detect a statistically significant increase in complete or near complete response rate from 30% in the single-transplant arm to 45% in the double-transplant arm. Primary study endpoint was the complete or near complete response rate. Secondary study endpoints were relapse-free survival, event-free survival and overall survival. The recruitment target was 324 patients. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00378222
Study type	Interventional
Source	University of Bologna
Contact
Status	Completed
Phase	Phase 3
Start date	January 1996
Completion date	November 2005

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
Terminated	`NCT03399448` - NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells)	Phase 1
Completed	`NCT03665155` - First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody	Phase 1/Phase 2
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	`NCT03792763` - Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients	Phase 2
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
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