Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL Amyloidosis

NACompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

June 24, 2011

Primary Completion Date

April 30, 2019

Study Completion Date

April 30, 2019

Conditions
Light Chain Deposition Disease (LCDD or MIDD)Light Chain and Heavy Chain Deposition Disease (LHCDD or MIDD)Monoclonal Immunoglobulin Deposition Disease (MIDD)Amyloidosis
Interventions
DRUG

Bortezomib/Dexamethasone (BD), Followed By Autologous STC & Maintenance Bortezomib/Dexamethasone

"The treatment has three phases:~1\) Initial treatment phase: This phase consists of 1-3 21-day-cycles of a combination regimen that includes bortezomib 1.3 mg/m2, IV or Subcutaneous Injection (SQ), on days 1, 4, 8, and 11; and dexamethasone 40 mg PO or IV, on days 1, 4, 8, and 11. Stem cell mobilization and HDM/ASCT. Post-ASCT consolidation/maintenance treatment phase: This phase consists of six cycles of bortezomib 1.3 mg/m2, IV or (SQ) with dexamethasone 20 mg PO or IV administered on days 1, 8, 15, and 22 every 12 weeks +/- 2 weeks. Long Term Follow Up will cease when all patients on study have fulfilled the requirements for at least five follow up appointments."

Trial Locations (5)

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester, Harrison

11725

Memorial Sloan Kettering Commack, Commack

07920

Memorial Sloan Kettering Basking Ridge, Basking Ridge

Unknown

Memorial Sloan Kettering Rockville Centre, Rockville Centre

Sponsors
All Listed Sponsors
collaborator

Millennium Pharmaceuticals, Inc.

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT01383759 - Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL Amyloidosis | Biotech Hunter | Biotech Hunter