A Phase III, Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and Granulocyte Colony Stimulating Factor (G-CSF) as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma (MM)
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Multiple Myeloma
In brief
A total of 122 subjects were randomized into the study and investigated in the double-blind placebo-controlled setting to assess the efficacy and safety of G-CSF + BL-8040 as compared to G-CSF + placebo.
Key facts
- Study ID
- NCT03246529
- Run by
- BioLineRx, Ltd.
- People needed
- 180
- Starts
- 2018-03-23
- Expected to finish
- 2029-09-30
- Last updated by the study team
- 2026-01-15
Who can join
Age: 18 and older, up to 78. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed Multiple Myeloma prior to enrolment and randomization.
- At least 1 week (7 days) from last induction cycle of combination/multi-agent cyto-reductive chemotherapy (e.g., KRD [carfilzomib, lenalidomide, dexamethasone] or VRD (e.g., bortezomib, lenalidomide, dexamethasone) or last single agent chemotherapy (e.g., lenalidomide, pomalidomide, bortezomib, dexamethasone, etc.) prior to the first dose of G-CSF for mobilization.
- Eligible for autologous hematopoietic stem cell transplantation according to the Investigator's 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 as defined as below:
- Hematology:
- White blood cell counts more than 2.5 x 10\^9/L
- Absolute neutrophil count more than 1.5 x 10\^9/L
- Platelet count more than 100 x10\^9/L Renal Function:
- Glomerular Filtration Rate (GFR) value of ≥15 mL/min/1.732 calculated by Modification of Diet in Renal Disease (MDRD) equation
- Hepatic function:
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 2.5 x ULN
- Total Bilirubin ≤ 2.0 x Upper Limit Normal (ULN) unless the subject has Gilbert disease
- Coagulation test:
- International Normalized Ratio (INR) or Prothrombin Time (PT): ≤1.5 x ULN unless subject is receiving anticoagulant therapy, as long as PT or Partial Thromboplastin Time (PTT) is within therapeutic range of intended use of anticoagulants
- Activated Partial Thromboplastin Time (aPTT): ≤1.5 x ULN unless subject is receiving anticoagulant therapy, as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- Male subjects must agree to use an adequate method of contraception starting with the first day of G-CSF administration through 30 days after the last dose of study drug.
- Patients must have a signed study informed consent prior to entering the study.
You may not qualify if…
- Previous history of autologous or allogeneic-Hematopoietic Cell Transplantation (HCT).
- Failed previous Hematopoietic Stem Cell (HSC) collections or collection attempts.
- 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;
- Pomalidomide: 7 days;
- Bortezomib: 7 days;
- Carfilzomib: 7 days;
- G-CSF: 14 days;
- Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) or Neulasta®: 21 days;
- Erythropoietin or erythrocyte stimulating agents: 30 days;
- Eltrombopag, romiplostim or platelet stimulating agents: 30 days;
- Carmustine (BCNU): 42 days/6 weeks;
- Daratumumab: 28 days;
- Ixazomib: 7 days.
- Received >6 cycles lifetime exposure to thalidomide or lenalidomide.
- Received >8 cycles of alkylating agent combinations.
- Received >6 cycles of melphalan.
- Received prior treatment with radioimmunotherapy (e.g., radionuclides, holmium).
- Received prior treatment with venetoclax.
- 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 G-CSF administration. Seasonal flu vaccines that do not contain live virus are permitted.
- Known active central nervous system (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.
Where it is running
- UCLA Medical Center — Los Angeles, California, United States
- University of Florida — Gainesville, Florida, United States
- University of Miami — Miami, Florida, United States
- Loyola University Medical Center — Chicago, Illinois, United States
- University of Maryland — Baltimore, Maryland, United States
- Mayo Clinic — Rochester, Minnesota, United States
- The Washington University School of Medicine — St Louis, Missouri, United States
- University of Cincinnati — Cincinnati, Ohio, United States
- MD Anderson Cancer Center — Houston Texas, Texas, United States
- Huntsman Cancer Institute in University of Utah — Salt Lake City, Utah, United States
- University of Koln — Cologne, Koln, Germany
- Central Hospital of Southern Pest National Institute of Hematology and Infectious Diseases — Budapest, Hungary
- University of Debrecen — Debrecen, Hungary
- Div. Clinicizzata di Ematologia - Policlinico Vittorio Emanuele — Catania, Italy
- Presidio Ospedaliero Morelli Viale Europa — Reggio Calabria, Italy
- Hospital de La Santa Creu I Sant Pau — Barcelona, Spain
- Hospital University Ramon y Cajal — Madrid, Spain
- Hospital Universitario 12 de Octubre — Madrid, Spain
Full record on ClinicalTrials.gov
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