A total of 207 subjects will be randomized into the study which will employ a double-blind
placebo-controlled setting to assess the efficacy and safety of G-CSF + BL-8040 as compared
to G-CSF + placebo.
- Part 1: This lead-in period designed to ascertain the dose of BL-8040 will enroll a
total of up to 30 subjects to an open labeled treatment to assess the efficacy, safety,
PK and PD parameters of treatment with G-CSF 10 µg/kg/day and BL-8040 1.25mg/kg, per
study protocol to goal collection of ≥ 6x106 CD34+ cells/kg.
- Part 2: Following the successful completion of Part 1, a total of 177 subjects will be
randomized into Part 2 of the study which will employ a double-blind placebo-controlled
setting to assess the efficacy and safety of G-CSF + BL-8040 as compared to G-CSF +
1. Histologically confirmed Multiple Myeloma prior to enrolment and randomization.
2. At least 4 weeks (112 days) from last induction cycle of combination/multi-agent
cyto-reductive chemotherapy and no single agent chemotherapy/maintenance within 7 days
(e.g. lenalidomide, pomalidomide, bortezomib, dexamethasone, etc).
3. Eligible for Autologous Hematopoietic stem cell transplantation according at the
4. The subjects should be in first or second CR (including CR and SCR) or PR (including
PR and VGPR)
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
6. Adequate organ function at baseline .
7. Subjects must use effective contraception.
1. Previous history of autologous or allogeneic-HCT
2. Failed previous HSC collections or collection attempts.
3. Patients whose apheresis product were to be further selected and purified
4. Taken any of the listed below concomitant medications, growth factors or stimulating
agents within the designated washout period:
1. Dexamethasone: 7 days
2. Thalidomide: 7 days
3. Lenalidomide: 7 days
4. Pamolidomide: 7 days
5. Bortezomib: 7 days
6. Carfilzomib: 7 days
7. G-CSF: 14 days
8. GM-CSF or Neulasta®: 21 days
9. Combination/multi-agent cyto-reductive therapy
10. Erythropoietin or erythrocyte stimulating agents: 30 days
11. Eltrombopag, romiplostim or platelet stimulating agents: 30 days
12. Carmustine (BCNU): 42 days/6 weeks
5. Received >6 cycles lifetime exposure to Lenalidomide.
6. Received >2 cycles of alkylating agent combinations.
7. Received 3-bis(2-chloroethyl)-1nitrosourea (BCNU or Carmustine) within 6 weeks prior
to anticipated first dose of G-CSF.
8. Received prior treatment with radioimmunotherapy, (e.g. radionuclides, holmium).
9. Received marrow stimulating factors:
1. Received G-CSF within 14 days prior to anticipated first dose of G-CSF.
2. Received Pegfilgrastim (GM-CSF or Nulesta) within 3 weeks prior to anticipated
first dose of G-CSF.
3. Received erythrocyte of platelet stimulating agents within 30 days prior to
anticipated first dose of G-CSF
10. Plans to receive maintenance treatment within 100 days post-engraftment (e.g.
Lenalidomide, Bortezomib, Pomalidomide, Thalidomide, Carfilzomib, etc.)
11. Has received a live vaccine within 30 days of the planned start of study therapy.
Seasonal flu vaccines that do not contain live virus are permitted.
12. Known active CNS metastases or carcinomatous meningitis.
13. A history of allergic reactions attributed to compounds of similar chemical or
biologic composition to BL-8040, G-CSF, or other agents used in the study.
16. Has an active infection requiring systemic therapy or uncontrolled infection. Has a
known additional malignancy that is progressing or requires active treatment. Has an
underlying medical condition that would preclude study participation.
17. Is currently participating and receiving study therapy or has participated in a study
of an investigational agent and received study therapy or used an investigational device
within 4 weeks of the first dose of treatment.
18. O2 saturation < 92% (on room air). 19. History of unexplained syncope, syncope from an
uncorrected cardiac etiology, or family history of sudden death.
20. History or family history of Long QT Syndrome or Torsade de Pointes. Myocardial
infarction, CABG, coronary or cerebral artery stenting and /or angioplasty, stroke, cardiac
surgery, or hospitalization for congestive heart failure within 3 months or greater than
Class 2 Angina Pectoris or NYHA Heart Failure Class >2. QTcF > 470 msec, PR > 280 msec,
Mobitz II 2nd degree AV Block, 2:1 AV Block, High Grade AV Block, or Complete Heart Block,
unless the patient has an implanted pacemaker or implantable cardiac defibrillator (ICD)
with backup pacing capabilities.
21. Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.
22. Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the trial, starting with the screening visit through 30 days after
the last dose of trial treatment.
23. Has a known history of HIV (HIV 1/2 antibodies), active / chronic Hepatitis B or C.