NCT03246529 · REGISTRY CONDITION SEARCH

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)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: ACTIVE NOT RECRUITING
Registry last update: 2026-01-15

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Subjects Mobilizing ≥6 × 10^6 CD34+ Cells/kg With up to 2 Apheresis Sessions

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outcome · POSTED

Percentage of Subjects Mobilizing ≥2 × 10^6 CD34+ Cells/kg in 1 Apheresis Session

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outcome · POSTED

Percentage of Subjects Mobilizing ≥6 × 10^6 CD34+ Cells/kg in 1 Apheresis Session

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outcome · POSTED

Time to Neutrophil Engraftment, After Auto-HCT

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outcome · POSTED

Time to Platelet Engraftment, After Auto-HCT

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outcome · POSTED

Subjects With Graft Durability at 100 Days Post Transplant/ Early Termination

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outcome · POSTED

Graft Durability at 6 Months Post Transplantation

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outcome · POSTED

Graft Durability at 9 Months Post Transplantation

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outcome · POSTED

Graft Durability at 12 Months Post Transplantation

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outcome · NOT POSTED

Overall Survival Until September 2028

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outcome · NOT POSTED

Relapse Free Survival Until September 2028

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outcome · NOT POSTED

Annualized Relapse Rate Until September 2028

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: 1. Histologically confirmed Multiple Myeloma prior to enrolment and randomization. 2. 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. 3. Eligible for autologous hematopoietic stem cell transplantation according to the Investigator's discretion. 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 screening as defined as below: 1. Hematology: * White blood cell counts more than 2.5 x 10\^9/L * Absolute neutrophil count more than 1.5 x 10\^9/L 2. 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 3. 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 4. 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 7. 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. 8. Patients must have a signed study informed consent prior to entering the study. Exclusion Criteria: 1. Previous history of autologous or allogeneic-Hematopoietic Cell Transplantation (HCT). 2. Failed previous Hematopoietic Stem Cell (HSC) collections or collection attempts. 3. 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. Pomalidomide: 7 days; 5. Bortezomib: 7 days; 6. Carfilzomib: 7 days; 7. G-CSF: 14 days; 8. Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) or Neulasta®: 21 days; 9. Erythropoietin or erythrocyte stimulating agents: 30 days; 10. Eltrombopag, romiplostim or platelet stimulating agents: 30 days; 11. Carmustine (BCNU): 42 days/6 weeks; 12. Daratumumab: 28 days; 13. Ixazomib: 7 days. 4. Received \>6 cycles lifetime exposure to thalidomide or lenalidomide. 5. Received \>8 cycles of alkylating agent combinations. 6. Received \>6 cycles of melphalan. 7. Received prior treatment with radioimmunotherapy (e.g., radionuclides, holmium). 8. Received prior treatment with venetoclax. 9. Plans to receive maintenance treatment within 60 days post-engraftment (e.g., lenalidomide, bortezomib, pomalidomide, thalidomide, carfilzomib, etc.) 10. 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. 11. Known active central nervous system (CNS) metastases or carcinomatous meningitis. 12. 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. 13. Has an active infection requiring systemic therapy or uncontrolled infection. 14. Has a known additional malignancy that is progressing or requires active treatment. 15. Has an underlying medical condition that would preclude study participation. 16. 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. 17. O2 saturation \< 92% (on room air). 18. Personal history or family history of Long QT Syndrome or Torsade de Pointes. 19. History of unexplained syncope, syncope from an uncorrected cardiac etiology, or family history of sudden cardiac death. 20. 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. 21. ECG in screening showing QTcF \> 470 msec, and/or PR \> 280 msec,. 22. 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. 23. 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. 24. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 25. 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. 26. Has a known history of HIV (HIV 1/2 antibodies) 27. 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). 28. Untreated or unsuccessfully treated Hepatitis B or C.
healthy Volunteers: false
maximum Age: 78 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Drug: BL-8040 1.25 mg/kg + G-CSF
label
BL-8040 1.25 mg/kg + G-CSF
type
EXPERIMENTAL
description
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.
intervention Names
Drug: Placebo +G-CSF
label
Placebo + G-CSF
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
BL-8040 1.25 mg/kg + G-CSF
description
Up to 2 subcutaneous (SC) injections of BL-8040 are anticipated during the study. Injections of G-CSF per standard of care
name
BL-8040 1.25 mg/kg + G-CSF
type
DRUG
arm Group Labels
Placebo + G-CSF
description
Up to 2 SC injections of Placebo are anticipated during the study. Injections of G-CSF per standard of care
name
Placebo +G-CSF
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

intervention 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 Info

masking: TRIPLE
who Masked: PARTICIPANT
CARE_PROVIDER
INVESTIGATOR

primary Purpose

TREATMENT

Enrollment

count: 180
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

description
Comparability between the effect of BL-8040 + G-CSF and placebo + G-CSF on Overall Survival until September 2028
measure
Overall Survival Until September 2028
time Frame
End of Study
description
Comparability between the effect of BL-8040 + G-CSF and placebo + G-CSF on Relapse Free Survival until September 2028
measure
Relapse Free Survival Until September 2028
time Frame
End Of Study
description
Comparability between the effect of BL-8040 + G-CSF and placebo + G-CSF on Annualized Relapse Rate until September 2028
measure
Annualized Relapse Rate Until September 2028
time Frame
End of Study

primary Outcomes

description
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.
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

secondary Outcomes

description
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.
measure
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
description
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.
measure
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
description
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.
measure
Time to Neutrophil Engraftment, After Auto-HCT
time Frame
End of engraftment period, which was defined as 29 days post transplantation
description
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.
measure
Time to Platelet Engraftment, After Auto-HCT
time Frame
End of engraftment period, which was defined as 29 days post transplantation
description
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.
measure
Subjects With Graft Durability at 100 Days Post Transplant/ Early Termination
time Frame
Day 100 Post-Transplantation (± 7 days)
description
Comparability of the graft durability between the BL-8040 + G-CSF arm and the placebo + G-CSF arm at 6 months post transplantation
measure
Graft Durability at 6 Months Post Transplantation
time Frame
6 Months Post Transplantation
description
Comparability of the graft durability between the BL-8040 + G-CSF arm and the placebo + G-CSF arm at 9 months post transplantation
measure
Graft Durability at 9 Months Post Transplantation
time Frame
9 Months Post Transplantation
description
Comparability of the graft durability between the BL-8040 + G-CSF arm and the placebo + G-CSF arm at 12 months post transplantation
measure
Graft Durability at 12 Months Post Transplantation
time Frame
12 Month Post Transplantation

Full study description

brief 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.
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.

Source references

references

citation
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.
pmid
37069359
type
DERIVED
citation
Crees 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.
pmid
31495201
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice