Exploratory Trial to Estimate Proportion of Patients With Tumor Cell Contaminated Leukapheresis Products With and Without Bortezomib With In-vivo Purging - Multiple Myeloma (MM)

High dose chemotherapy with autologous stem cell transplant has resulted in improved overall
survival and is currently considered an effective first line therapy applicable to the
majority of patients with multiple myeloma. However disease relapse is inevitable and remains
the primary cause of mortality in this cohort.

The purpose of this study is to estimate the proportion of subjects with plasma cell
contamination of harvested stem cell product in standard and treatment arms. The study will
explore whether or not in-vivo purging of malignant tumor plasma cells will improve
progression free survival (PFS) for patients.

The study will consist of two groups:

Group A: Standard of Care (SOC) stem cell collection without in-vivo purging with bortezomib.
Granulocyte colony-stimulating factor (G-CSF) and Mozobil used if needed.

Group B: Bortezomib 1.3mg/m^2 will be given subcutaneously (SQ) on days -11 and -8 followed
by Granulocyte colony-stimulating factor (G-CSF) on days -4 through -1 prior to stem cell
harvest (day 0).

Inclusion Criteria:

- Subjects must meet all of the inclusion criteria to participate in this study.

- Ability to understand, and the willingness to sign a written Informed Consent Form

- Diagnosis of multiple myeloma undergoing planned autologous stem cell transplantation

- Age ≥ 18 years

- Karnofsky Performance Status (KPS) 70 or above, Eastern Cooperative Oncology Group
(ECOG) 0, 1 or 2

- Adequate organ and marrow function as defined below:

- leukocytes ≥ 3,000/micro Liter (mcL)

- absolute neutrophil count ≥ 1,500/mcL

- platelets ≥ 100,000/mcL

- total bilirubin within normal institutional limits NOTE: For this study, subjects
with bilirubin levels > 1.5 Upper Limit of Normal (ULN) are excluded from
enrollment in this study.

- Aspartate Aminotransferase (AST) ( Serum Glutamic Oxaloacetic Transaminase
[SGOT]) ≤ 2.5 X institutional upper limit of normal

- Alanine Aminotransferase (ALT) (Serum Pyruvic Glutamic Transaminase [SPGT]) ≤ 2.5
X institutional upper limit of normal

- creatinine within normal institutional limits

- Women of child-bearing potential and men with partners of child-bearing potential must
agree to use adequate contraception (hormonal or barrier method of birth control;
abstinence) prior to study entry, for the duration of study participation, and for 30
days following completion of therapy. Should a woman or partner become pregnant or
suspect she is pregnant while participating in this study, she should inform her
treating physician and the investigator immediately.

- A woman of child-bearing potential is any female (regardless of sexual orientation,
having undergone a tubal ligation, or remaining celibate by choice) who meets the
following criteria:

- Has not undergone a hysterectomy or bilateral oophorectomy; or

- Has not been naturally postmenopausal for at least 12 consecutive months (i.e.,
has had menses at any time in the preceding 12 consecutive months)

Exclusion Criteria:

- Subjects meeting any of the exclusion criteria at baseline will be excluded from study
participation.

- Current or anticipated use of other investigational agents. NOTE the following
clarification for this study: Prohibited Concurrent Therapy:

Participation in clinical trials with other investigational agents that are not included in
this trial, within 14 days of the start of this trial until 2 weeks after participant has
received the last dose of bortezomib for mobilization.

- Hypersensitivity to bortezomib, boron or mannitol or Granulocyte colony-stimulating
factor (G-CSF)

- Subject has received > 6 months of lenalidomide (Revlimid®) therapy prior to stem cell
collection

- Subject has known brain metastases. Presence of brain metastases should be excluded
from this clinical trial because of poor prognosis and because patients often develop
progressive neurologic dysfunction that would confound the evaluation of neurologic
and other adverse events.

- Grade 3 or higher peripheral neuropathy

- Bilirubin levels > 1.5 ULN

- Uncontrolled inter-current illness including, but not limited to

- ongoing or active infection

- symptomatic congestive heart failure

- unstable angina pectoris

- cardiac arrhythmia

- psychiatric illness/social situations that would limit compliance with study
requirements

- Pregnant or nursing: There is a potential for congenital abnormalities and for this
regimen to harm nursing infants.