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