Multiple MyelomaPhase 3GENESISNCT03246529
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)
A Phase 3 study testing BL-8040 1.25 mg/kg + G-CSF in people with Multiple Myeloma, run by BioLineRx, Ltd. at 18 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- BL-8040 1.25 mg/kg + G-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 18 sitesin 5 countries
- Study dates
- 23 Mar 2018to 30 Sep 2029
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 19Show fewer
- 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.
Who cannot join
- 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;
Show all 41Show fewer
- 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.
- 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).
- Personal history or family history of Long QT Syndrome or Torsade de Pointes.
- History of unexplained syncope, syncope from an uncorrected cardiac etiology, or family history of sudden cardiac death.
- Myocardial infarction, coronary artery bypass grafting (CABG), coronary or cerebral artery stenting and /or angioplasty, stroke, cardiac surgery, or hospitalization for congestive heart failure within 3 months or greater than Angina Pectoris Class >2 or New York Heart Association (NYHA) Heart Failure >2.
- ECG in screening showing QTcF > 470 msec, and/or PR > 280 msec,.
- Mobitz II 2nd degree Atrioventricular (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 a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- 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 within the projected duration of the trial, starting with the screening visit through 30 days after the last dose of study drug.
- Has a known history of HIV (HIV 1/2 antibodies)
- Has known active Hepatitis B (e.g., Hepatitis B Surface Antigen [HBsAg] reactive) or Hepatitis C (e.g., Hepatitis C Virus [HCV] RNA [qualitative] is detected).
- Untreated or unsuccessfully treated Hepatitis B or C.
Trial locations and contacts
18 sites in 5 countries.
18 sites in 5 countries
United States10 sites
University of Maryland
Baltimore, Maryland, 21201
Loyola University Medical Center
Chicago, Illinois, 60611
University of Cincinnati
Cincinnati, Ohio, 45221
University of Florida
Gainesville, Florida, 100278
MD Anderson Cancer Center
Houston Texas, Texas, 77030
UCLA Medical Center
Los Angeles, California, 167817
University of Miami
Miami, Florida, 33136
Mayo Clinic
Rochester, Minnesota, 55902
Huntsman Cancer Institute in University of Utah
Salt Lake City, Utah, 84112
The Washington University School of Medicine
St Louis, Missouri, 63110
Spain3 sites
Hospital de La Santa Creu I Sant Pau
Barcelona, 08041
Hospital University Ramon y Cajal
Madrid, 135250
Hospital Universitario 12 de Octubre
Madrid, 28041
Hungary2 sites
Central Hospital of Southern Pest National Institute of Hematology and Infectious Diseases
Budapest, 1097
University of Debrecen
Debrecen, 4032
Italy2 sites
Div. Clinicizzata di Ematologia - Policlinico Vittorio Emanuele
Catania, 95124
Presidio Ospedaliero Morelli Viale Europa
Reggio Calabria, 89133
About this study
Official title: A Phase III, Randomized, Placebo-Controlled, Multi-Centre Study Evaluating the Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and G-CSF as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma - The GENESIS Study
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.
Read the detailed description
- Part 1: This lead-in period, designed to ascertain the dose of BL-8040, enrolled a total of 12 subjects to an open labeled treatment to assess the efficacy, safety, pharmacokinetic (PK) and pharmacodynamic (PD) parameters of treatment with G-CSF 10 µg/kg/day and BL-8040 1.25 mg/kg, per study protocol to goal collection of ≥ 6 × 10^6 CD34+ cells/kg.
- Part 2: Following the successful completion of Part 1, a total of 122 subjects were randomized into Part 2 of the study which employed a double-blind placebo-controlled setting to assess the efficacy and safety of G-CSF + BL-8040 as compared to G-CSF + placebo.
- Conditions
- Multiple Myeloma
- Being tested
- BL-8040 1.25 mg/kg + G-CSF, Placebo +G-CSF
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL-8040 1.25 mg/kg + G-CSFDrug
Up to 2 subcutaneous (SC) injections of BL-8040 are anticipated during the study. Injections of G-CSF per standard of care
Placebo +G-CSFDrug
Up to 2 SC injections of Placebo are anticipated during the study. Injections of G-CSF per standard of care
| Study group | Role | What they receive |
|---|---|---|
| BL-8040 1.25 mg/kg + G-CSF | Experimental | Double-blind placebo-controlled setting designed to assess the safety, tolerability and efficacy of G-CSF + BL-8040 as compared to G-CSF + Placebo, for stem cell mobilization in MM. Receives: Drug: BL-8040 1.25 mg/kg + G-CSF |
| Placebo + G-CSF | Active comparator | Double-blind placebo-controlled setting designed to assess the safety, tolerability and efficacy of G-CSF + BL-8040 as compared to G-CSF + Placebo, for stem cell mobilization in MM. Receives: Drug: Placebo +G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Mobilizing ≥6 × 10^6 CD34+ Cells/kg With up to 2 Apheresis Sessions
Percentage of subjects mobilizing ≥6 × 10^6 CD34+ cells/kg with up to 2 apheresis sessions in preparation for autologous hematopoetic cell transplantation (auto-HCT) after treatment with G-CSF + single administration of BL-8040/placebo.
Based on central laboratory data.
Measured: From first day of study treatment (G-CSF) until day of second apheresis which was planned to occur on Day 6
Secondary outcomes (8)
Percentage of Subjects Mobilizing ≥2 × 10^6 CD34+ Cells/kg in 1 Apheresis Session
Percentage of subjects mobilizing ≥2 × 10^6 CD34+ cells/kg in 1 apheresis session after treatment with G-CSF + single administration of BL-8040/ placebo.
Measured: From first day of study treatment (G-CSF) until day of first apheresis which was planned to occur on Day 5
Percentage of Subjects Mobilizing ≥6 × 10^6 CD34+ Cells/kg in 1 Apheresis Session
Percentage of subjects mobilizing ≥6 × 10^6 CD34+ cells/kg in 1 apheresis session after treatment with G-CSF + single administration of BL-8040/ placebo.
Measured: From first day of study treatment (G-CSF) until day of first apheresis which was planned to occur on Day 5
Time to Neutrophil Engraftment, After Auto-HCT
Time to neutrophil engraftment after auto-HCT, where engraftment was defined as absolute neutrophil count (ANC) ≥0.5 × 10^9/L for 3 days or ≥1.0 × 10^9/L for 1 day following the conditioning regimen associated nadir.
Measured: End of engraftment period, which was defined as 29 days post transplantation
Time to Platelet Engraftment, After Auto-HCT
Time to platelet engraftment, after auto-HCT, where engraftment was defined as the first of 3 consecutive measurements of platelet count ≥20 × 10^9/L without platelet transfusion support for 7 days following the conditioning regimen associated nadir.
Measured: End of engraftment period, which was defined as 29 days post transplantation
Subjects With Graft Durability at 100 Days Post Transplant/ Early Termination
Subjects achieving graft durability were defined as meeting the following 2 criteria:
- Platelet count ≥50 × 10^9/L without transfusion for at least 2 weeks.
- Hemoglobin level ≥10 g/dL with no erythropoietin support or transfusions for at least 1 month.
This analysis was performed in part 2 of the study only.
Measured: Day 100 Post-Transplantation (± 7 days)
Graft Durability at 6 Months Post Transplantation
Comparability of the graft durability between the BL-8040 + G-CSF arm and the placebo + G-CSF arm at 6 months post transplantation
Measured: 6 Months Post Transplantation
Graft Durability at 9 Months Post Transplantation
Comparability of the graft durability between the BL-8040 + G-CSF arm and the placebo + G-CSF arm at 9 months post transplantation
Measured: 9 Months Post Transplantation
Graft Durability at 12 Months Post Transplantation
Comparability of the graft durability between the BL-8040 + G-CSF arm and the placebo + G-CSF arm at 12 months post transplantation
Measured: 12 Month Post Transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start23 Mar 2018
- Primary completion22 Dec 2020
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects were randomized using a 2:1 ratio to receive G-CSF + BL-8040 or G-CSF + Placebo, respectively. Randomization will use permuted blocks stratifying subjects by US geographical region (NorthEast, SouthEast, MidWest, SouthWest and NorthWest), remission status (CR vs. PR), and baseline platelet count (\< 200 × 10\^9/L or ≥ 200 × 10\^9/L).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioLineRx, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John DiPersio, MD, Principal investigator, Washington University School of MedicineCrees Zachary, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246529
- Sponsor's protocol ID
- BL-8040.SCM.301
- Acronym
- GENESIS
- Status last verified
- Dec 2025
- First submitted
- 2 Aug 2017
- Last updated
- 15 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Crees ZD, Rettig MP, Jayasinghe RG, Stockerl-Goldstein K, Larson SM, Arpad I, Milone GA, Martino M, Stiff P, Sborov D, Pereira D, Micallef I, Moreno-Jimenez G, Mikala G, Coronel MLP, Holtick U, Hiemenz J, Qazilbash MH, Hardy N, Latif T, Garcia-Cadenas I, Vainstein-Haras A, Sorani E, Gliko-Kabir I, Goldstein I, Ickowicz D, Shemesh-Darvish L, Kadosh S, Gao F, Schroeder MA, Vij R, DiPersio JF. Motixafortide and G-CSF to mobilize hematopoietic stem cells for autologous transplantation in multiple myeloma: a randomized phase 3 trial. Nat Med. 2023 Apr;29(4):869-879. doi: 10.1038/s41591-023-02273-z. Epub 2023 Apr 17.
PubMed 37069359Crees ZD, Stockerl-Goldstein K, Vainstein A, Chen H, DiPersio JF. GENESIS: Phase III trial evaluating BL-8040 + G-CSF to mobilize hematopoietic cells for autologous transplant in myeloma. Future Oncol. 2019 Nov;15(31):3555-3563. doi: 10.2217/fon-2019-0380. Epub 2019 Sep 9.
PubMed 31495201
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Placebo-Controlled, Multi-Centre Study Evaluating the Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and G-CSF as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma - The GENESIS Study
- ClinicalTrials.gov ID
- NCT03246529
- Acronym / sponsor ID
- GENESIS / BL-8040.SCM.301
- Conditions
- Multiple Myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (actual)
- Lead sponsor
- BioLineRx, Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 11 Aug 2017 (actual)
- Results
- Posted 7 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Part 1: This lead-in period, designed to ascertain the dose of BL-8040, enrolled a total of 12 subjects to an open labeled treatment to assess the efficacy, safety, pharmacokinetic (PK) and pharmacodynamic (PD) parameters of treatment with G-CSF 10 µg/kg/day and BL-8040 1.25 mg/kg, per study protocol to goal collection of ≥ 6 × 10^6 CD34+ cells/kg.
- Part 2: Following the successful completion of Part 1, a total of 122 subjects were randomized into Part 2 of the study which employed a double-blind placebo-controlled setting to assess the efficacy and safety of G-CSF + BL-8040 as compared to G-CSF + placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Subjects were randomized using a 2:1 ratio to receive G-CSF + BL-8040 or G-CSF + Placebo, respectively. Randomization will use permuted blocks stratifying subjects by US geographical region (NorthEast, SouthEast, MidWest, SouthWest and NorthWest), remission status (CR vs. PR), and baseline platelet count (< 200 × 10^9/L or ≥ 200 × 10^9/L).
| Arm | Type | Receives |
|---|---|---|
| BL-8040 1.25 mg/kg + G-CSF | Experimental | Drug: BL-8040 1.25 mg/kg + G-CSFDouble-blind placebo-controlled setting designed to assess the safety, tolerability and efficacy of G-CSF + BL-8040 as compared to G-CSF + Placebo, for stem cell mobilization in MM. |
| Placebo + G-CSF | Active comparator | Drug: Placebo +G-CSFDouble-blind placebo-controlled setting designed to assess the safety, tolerability and efficacy of G-CSF + BL-8040 as compared to G-CSF + Placebo, for stem cell mobilization in MM. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (41 listed)
- 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:
- Received >6 cycles lifetime exposure to thalidomide or lenalidomide.
- Received >8 cycles of alkylating agent combinations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BL-8040 1.25 mg/kg + G-CSFUp to 2 subcutaneous (SC) injections of BL-8040 are anticipated during the study. Injections of G-CSF per standard of care | Drug | BL-8040 1.25 mg/kg + G-CSF |
| Placebo +G-CSFUp to 2 SC injections of Placebo are anticipated during the study. Injections of G-CSF per standard of care | Drug | Placebo + G-CSF |
Primary outcome
Percentage of Subjects Mobilizing ≥6 × 10^6 CD34+ Cells/kg With up to 2 Apheresis Sessions
Time frame: From first day of study treatment (G-CSF) until day of second apheresis which was planned to occur on Day 6
Percentage of subjects mobilizing ≥6 × 10^6 CD34+ cells/kg with up to 2 apheresis sessions in preparation for autologous hematopoetic cell transplantation (auto-HCT) after treatment with G-CSF + single administration of BL-8040/placebo. Based on central laboratory data.
8 secondary outcomes
Percentage of Subjects Mobilizing ≥2 × 10^6 CD34+ Cells/kg in 1 Apheresis Session
Time frame: From first day of study treatment (G-CSF) until day of first apheresis which was planned to occur on Day 5
Percentage of Subjects Mobilizing ≥6 × 10^6 CD34+ Cells/kg in 1 Apheresis Session
Time frame: From first day of study treatment (G-CSF) until day of first apheresis which was planned to occur on Day 5
Time to Neutrophil Engraftment, After Auto-HCT
Time frame: End of engraftment period, which was defined as 29 days post transplantation
Time to Platelet Engraftment, After Auto-HCT
Time frame: End of engraftment period, which was defined as 29 days post transplantation
Subjects With Graft Durability at 100 Days Post Transplant/ Early Termination
Time frame: Day 100 Post-Transplantation (± 7 days)
Graft Durability at 6 Months Post Transplantation
Time frame: 6 Months Post Transplantation
Graft Durability at 9 Months Post Transplantation
Time frame: 9 Months Post Transplantation
Graft Durability at 12 Months Post Transplantation
Time frame: 12 Month Post Transplantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37069359Crees ZD, Rettig MP, Jayasinghe RG, Stockerl-Goldstein K, Larson SM, Arpad I, Milone GA, Martino M, Stiff P, Sborov D, Pereira D, Micallef I, Moreno-Jimenez G, Mikala G, Coronel MLP, Holtick U, Hiemenz J, Qazilbash MH, Hardy N, Latif T, Garcia-Cadenas I, Vainstein-Haras A, Sorani E, Gliko-Kabir I, Goldstein I, Ickowicz D, Shemesh-Darvish L, Kadosh S, Gao F, Schroeder MA, Vij R, DiPersio JF. Motixafortide and G-CSF to mobilize hematopoietic stem cells for autologous transplantation in multiple myeloma: a randomized phase 3 trial. Nat Med. 2023 Apr;29(4):869-879. doi: 10.1038/s41591-023-02273-z. Epub 2023 Apr 17.
- Derived from this study: PubMed 31495201Crees ZD, Stockerl-Goldstein K, Vainstein A, Chen H, DiPersio JF. GENESIS: Phase III trial evaluating BL-8040 + G-CSF to mobilize hematopoietic cells for autologous transplant in myeloma. Future Oncol. 2019 Nov;15(31):3555-3563. doi: 10.2217/fon-2019-0380. Epub 2019 Sep 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John DiPersio, MD principal investigator
Washington University School of Medicine
Crees Zachary, MD principal investigator
Washington University School of Medicine
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BL-8040 1.25 mg/kg + G-CSF in people with Multiple Myeloma, run by BioLineRx, Ltd. at 18 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Spain, Hungary, Italy, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects Mobilizing ≥6 × 10^6 CD34+ Cells/kg With up to 2 Apheresis Sessions (time frame: From first day of study treatment (G-CSF) until day of second apheresis which was planned to occur on Day 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03246529, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.