Tandem Auto Stem Cell Transplant With Melphalan Followed by Melphalan and Bortezomib in Patients With Multiple Myeloma
Conditions
Multiple Myeloma - Auto Stem Cell Transplant
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Bortezomib
Type: Drug
Overall Status
Recruiting
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.
Detailed Description
Many patients with multiple myeloma receive 2 stem cell transplantations within a few months of each other as part of their treatment. Usually the drug Melphalan is used for both transplants.

Bortezomib is a drug that is used for treating multiple myeloma and has been used in combination with melphalan for stem cell transplantation for patients with multiple myeloma.

The purpose of this trial is to study the effects of doing 2 transplants, first using melphalan and second using melphalan and bortezomib. The trial is aiming to find out if adding the Bortezomib to the second transplant will increase the chances of staying in remission longer.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
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
Location
John Theurer Cancer Center @ Hackensack University Medical Center
Hackensack, New Jersey, United States
Status: Recruiting
Contact: Emily Brown, RN - 551-996-3923 - EmilyBrown@hackensackUMC.org
Start Date
April 2010
Completion Date
May 2015
Sponsors
Hackensack University Medical Center
Source
Hackensack University Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page