Multiple Myeloma Clinical Trial

A Phase III, Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and G-GSF as Compared to Placebo and G-CSF for thE MobilizatioN of HematopoiEtic Stem Cells for Autologous TransplantatIon in SubjectS With MM

Summary

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.

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Full Description

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 + placebo.

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Eligibility Criteria

Inclusion Criteria:

Histologically confirmed Multiple Myeloma prior to enrolment and randomization.
At least 1 weeks (7 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).
Eligible for Autologous Hematopoietic stem cell transplantation according at the investigator discretion.
The subjects should be in first or second CR (including CR and SCR) or PR (including PR and VGPR)
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Adequate organ function at screening .
Subjects must use effective contraception.

Exclusion Criteria:

Previous history of autologous or allogeneic-HCT
Failed previous HSC collections or collection attempts.
Patients whose apheresis product were to be further selected and purified

Taken any of the listed below concomitant medications, growth factors or stimulating agents within the designated washout period:

Dexamethasone: 7 days
Thalidomide: 7 days
Lenalidomide: 7 days
Pamolidomide: 7 days
Bortezomib: 7 days
Carfilzomib: 7 days
G-CSF: 14 days
GM-CSF or Neulasta®: 21 days
Combination/multi-agent cyto-reductive therapy
Erythropoietin or erythrocyte stimulating agents: 30 days
Eltrombopag, romiplostim or platelet stimulating agents: 30 days
Carmustine (BCNU): 42 days/6 weeks

l. Daratumumab: 28 days m. Ixazomib: 7 days

Received >6 cycles lifetime exposure to Lenalidomide.
Received >8 cycles of alkylating agent combinations.
Received > 6 cycles of melphalan
Received 3-bis(2-chloroethyl)-1nitrl.
Received prior treatment with radioimmunotherapy, (e.g. radionuclides, holmium).

Received marrow stimulating factors:

Received G-CSF within 14 days prior to anticipated first dose of G-CSF.
Received Pegfilgrastim (GM-CSF or Nulesta) within 3 weeks prior to anticipated first dose of G-CSF.
Received erythrocyte of platelet stimulating agents within 30 days prior to anticipated first dose of G-CSF
Plans to receive maintenance treatment within 60 days post-engraftment (e.g. Lenalidomide, Bortezomib, Pomalidomide, Thalidomide, Carfilzomib, etc.)
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.
Known active CNS metastases or carcinomatous meningitis.
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.
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.
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.
O2 saturation < 92% (on room air).
History of unexplained syncope, syncope from an uncorrected cardiac etiology, or family history of sudden death.
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.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
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.
Has a known history of HIV (HIV 1/2 antibodies), active / chronic Hepatitis B or C.

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

136

Study ID:

NCT03246529

Recruitment Status:

Active, not recruiting

Sponsor:

BioLineRx, Ltd.

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There are 16 Locations for this study

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UCLA Medical Center
Los Angeles California, 16781, United States
University of Florida
Gainesville Florida, 10027, United States
University of Miami
Miami Florida, 33136, United States
Loyola University Medical Center
Chicago Illinois, 60611, United States
University of Maryland
Baltimore Maryland, 21201, United States
The Washington University in St. Louis
Saint Louis Missouri, 63110, United States
Mayo Clinic, Rochester
Rochester New York, 55902, United States
University of Cincinnati
Cincinnati Ohio, 45221, United States
MD Anderson Cancer Center
Texas City Texas, 77030, United States
Huntsman Cancer Institute University of Utah
Salt Lake City Utah, 84112, United States
University of Koln
Köln Koln, 50923, Germany
Central Hospital of Southern Pest National Institute of Hematology and Infectious Diseases
Budapest , , Hungary
University of Debrecen
Debrecen , 4027, Hungary
Div. Clinicizzata di Ematologia - Policlinico Vittorio Emanuele
Catania , 95124, Italy
Div. Clinicizzata di Ematologia - Policlinico Vittorio Emanuele
Reggio Calabria , 89133, Italy
Hospital De La Santa Creu I Sant Pau
Barcelona , 08041, Spain
Hospital University Ramon y Cajal
Madrid , 13525, Spain
Hospital Universitario 12 de Octubre
Madrid , , Spain

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

136

Study ID:

NCT03246529

Recruitment Status:

Active, not recruiting

Sponsor:


BioLineRx, Ltd.

How clear is this clinincal trial information?

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