Tandem Auto Stem Cell Transplant With Melphalan Followed by Melphalan and Bortezomib in Patients With Multiple Myeloma

• Status: Active, not recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

High dose chemotherapy with stem cell transplantation is commonplace in the treatment of multiple myeloma. This treatment uses a chemotherapy drug called Melphalan that has been used in several thousand bone marrow transplant recipients worldwide for the same or similar disorders.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hackensack Meridian Health; Hackensack University Medical Center
• Treatments: Bortezomib; Melphalan

Criteria

Changed from: Inclusion Criteria:

• Confirmed diagnosis of multiple myeloma with either Durie-Salmon stage I, II, or III or ISS stage I, II or III, less than 12 months since initiation of systemic therapy

• ≥8x106 CD34+cells/kg available in cryopreservation in aliquots appropriate for tandem transplants

• Age: 18-75 years at time of transplantation

• KPS 70-100%

• Recovery from complications of prior therapies

• Gender: There is no gender restriction

Exclusion Criteria:

• Diagnosis other than multiple myeloma

• Chemotherapy or radiotherapy within 8 days of initiating treatment in this study

• Prior autologous or allogeneic transplantation (except as enrolled into this study)

• Uncontrolled bacterial, viral, fungal or parasitic infections