IV Busulfan Plus Bortezomib Conditioning Regimen for Second Autologous Stem Cell Transplant in Multiple Myeloma Patients

Inclusion criteria

• . Age 18 to 75 years, inclusive.
• . Subjects must have multiple myeloma which requires treatment for relapsed disease and are eligible for the planned autologous HSCT.
• . Subjects must have had one previous autologous HSCT, at least one year prior to the planned autologous HSCT in this study.
• . Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
• . Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test in all women of child-bearing potential.
• . Subjects who are surgically sterile (ie, have undergone orchidectomy or hysterectomy); female subjects who have been postmenopausal for at least 12 consecutive months; or subjects who agree to remain abstinent or to practice double-barrier forms of birth control from trial screening through 30 days (for females) and 90 days (for males) from the last dose of the investigational medicinal product (IMP). If employing birth control, two of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device (IUD), birth control pill, birth control implant, condom, or sponge with spermicide.
• . Subjects in whom the minimum stem cell dose of 2.0 x 10\^6 cluster of differentiation 34 (CD34)+ cells/kg has been collected.
• . Ability to provide written informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the Principal Investigator, to comply with all requirements of the study.

Exclusion criteria