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Safety and efficacy of BL-8040 with G-CSF compared to Placebo with G-CSF for the collection of peripheral blood stem cells for autologous transplantation in patients with multiple myeloma
EU CTIS ID: 2024-511953-23-00
What this study is testing
To demonstrate the superiority of one dose of BL-8040 + G-CSF over placebo + G-CSF to mobilize ≥6.0 x 10^6 CD34+ cells/kg in up to 2 apheresis sessions in preparation for autologous hematopoietic cell transplantation (auto-HCT) in multiple myeloma (MM) subjects.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients must be between the ages of 18 and 78 years.
- Women of childbearing potential must agree to use 2 methods of effective contraception: One barrier method (e.g. diaphragm, or condom or sponge, each of which are to be combined with a spermicide) and one hormonal method, unless she uses a highly effective method. Highly effective methods of contraception include: • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal • Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable • Intrauterine device (IUD) • Intrauterine hormone-releasing system (IUS) • Bilateral tubal occlusion • Vasectomised partner • Sexual abstinence These methods must be used prior to study entry and for the duration of study participation through 30 days after the last dose of study treatment. Non-childbearing potential is defined as (by other than medical reasons): • ≥45 years of age and has not had menses for over 2 years. • Amenorrheic for > 2 years without a hysterectomy and oophorectomy and a Follicle Stimulating Hormone (FSH) value in the postmenopausal range upon pre-trial (screening) evaluation. • Post hysterectomy, bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation at least 6 weeks prior to screening. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure; otherwise the subject must be willing to use two adequate barrier methods throughout the study, starting with the Screening Visit, through 30 days after the last dose of study drug. Information must be captured appropriately within the site's source documents.
- 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.
- Histologically confirmed Multiple Myeloma prior to enrollment and randomization.
- At least one week (7 days) from last induction cycle of combination/multi-agent chemotherapy (e.g. KRD [carfilzomib, lenalidomide, dexamethasone] or VRD [bortezomib, lenalidomide, dexamethasone]) or from last single agent chemotherapy (e.g. lenalidomide, pomalidomide, bortezomib, dexamethasone, etc) prior to the first dose of G-CSF for mobilization.
You likely can't join if
- Previous history of autologous or allogeneic-HCT.
- 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 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.
See the full eligibility criteria
Who can join
- Patients must be between the ages of 18 and 78 years.
- Women of childbearing potential must agree to use 2 methods of effective contraception: One barrier method (e.g. diaphragm, or condom or sponge, each of which are to be combined with a spermicide) and one hormonal method, unless she uses a highly effective method. Highly effective methods of contraception include: • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal • Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable • Intrauterine device (IUD) • Intrauterine hormone-releasing system (IUS) • Bilateral tubal occlusion • Vasectomised partner • Sexual abstinence These methods must be used prior to study entry and for the duration of study participation through 30 days after the last dose of study treatment. Non-childbearing potential is defined as (by other than medical reasons): • ≥45 years of age and has not had menses for over 2 years. • Amenorrheic for > 2 years without a hysterectomy and oophorectomy and a Follicle Stimulating Hormone (FSH) value in the postmenopausal range upon pre-trial (screening) evaluation. • Post hysterectomy, bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation at least 6 weeks prior to screening. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure; otherwise the subject must be willing to use two adequate barrier methods throughout the study, starting with the Screening Visit, through 30 days after the last dose of study drug. Information must be captured appropriately within the site's source documents.
- 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.
- Histologically confirmed Multiple Myeloma prior to enrollment and randomization.
- At least one week (7 days) from last induction cycle of combination/multi-agent chemotherapy (e.g. KRD [carfilzomib, lenalidomide, dexamethasone] or VRD [bortezomib, lenalidomide, dexamethasone]) or from 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 below: a. 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 b. Renal Function: • GFR value of ≥15 mL/min/1.73^2 calculated by MDRD equation c. Hepatic function: • ALT and/or AST ≤ 2.5 x ULN • Total Bilirubin ≤ 2.0 x ULN unless the subject has Gilbert disease d. Coagulation test: • INR or PT: ≤1.5xULN unless subject is receiving anticoagulant therapy, as long as PT or PTT is within therapeutic range of intended use of anticoagulants • aPTT: ≤1.5xULN unless subject is receiving anticoagulant therapy, as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- Female subjects must be of non-childbearing potential or, if of childbearing potential, must have a negative serum pregnancy test at screening and negative urine/serum pregnancy test within 72 hours prior to G-CSF first administration.
What rules you out
- Previous history of autologous or allogeneic-HCT.
- 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 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.
- Failed previous HSC collections or collection attempts.
- 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 Angina Pectoris Class >2 or NYHA Heart Failure Class >2.
- ECG at screening showing QTcF > 470 msec and/or 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 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 breast feeding or expecting to conceive or women of childbearing potential unless consent to use two contraceptive methods or highly effective contraception as detailed above, 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.
- Taken any of the listed below concomitant medications, growth factors or stimulating agents within the designated washout period: a. Dexamethasone: 7 days b. Thalidomide: 7 days c. Lenalidomide: 7 days d. Pamolidomide: 7 days e. Bortezomib: 7 days f. Carfilzomib: 7 days g. G-CSF: 14 days h. GM-CSF or Neulasta®: 21 days i. Erythropoietin or erythrocyte stimulating agents: 30 days j. Eltrombopag, romiplostim or platelet stimulating agents: 30 days k. Carmustine (BCNU): 42 days/6 weeks l. Daratumumab: 28 days m. 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 posttransplantation (e.g. lenalidomide, bortezomib, pomalidomide, thalidomide, carfilzomib, etc.).
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.