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

Explore stem cell collection with or without bortezomib with in-vivo purging in multiple
myeloma.

Eligibility Criteria

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 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.

Principal Investigator

Siddhartha Ganguly, MD

Study Contact

Kelly Daniels, kdaniels2@kumc.edu, 913-945-6691

Estimated Completion Date

Thursday, February 1, 2018

ClinicalTrials.gov #

NCT02703779
03/08/2016