BridgeMD
New treatment option for Multiple Myeloma
Official title Mobilization of Stem Cells With Motixafortide (BL-8040) in Combination With G-CSF in Multiple Myeloma Patients
ClinicalTrials.gov ID: NCT06514508
What this study is testing
What is Motixafortide+G-CSF?
Motixafortide+G-CSF is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for multiple myeloma.
Also referred to as BL-8040+G-CSF.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a randomized, double-blinded, placebo-controlled, multi-center phase Ⅲ bridging clinical study designed to evaluate the efficacy, safety, and pharmacokinetic and pharmacodynamic profiles of Motixafortide (BL-8040) + G-CSF vs placebo + G-CSF mobilized hematopoietic stem cells for autologous transplantation in Chinese patients with multiple myeloma.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 78
You may be able to join if
- (Limit: 15,000 characters)
- Patients must have a signed study informed consent prior to entering the study.
- Patients must be between the ages of 18 and 78 years.
- Diagnosis of active multiple myeloma (aMM) as defined by IMWG criteria.
- At least one week (7 days) from last induction cycle of combination/multi-agent chemotherapy (e.g. KRD [carfilzomib, lenalidomide, dexamethasone] or...
You likely can't join if
- Previous history of autologous or allogeneic-HCT.
- Failed previous 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
See the full eligibility criteria
- (Limit: 15,000 characters)
- Patients must have a signed study informed consent prior to entering the study.
- Patients must be between the ages of 18 and 78 years.
- Diagnosis of active multiple myeloma (aMM) as defined by IMWG criteria.
- 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...
- Eligible for Autologous Hematopoietic stem cell transplantation according to the Investigator's discretion.
- The people 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.
- Female people must be of non-childbearing potential or, if of childbearing potential, must have a negative serum pregnancy test at screening and negative serum pregnancy test within 72 hours prior to G-CSF first...
- Previous history of autologous or allogeneic-HCT.
- Failed previous 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
- Pamolidomide: 7 days
- Bortezomib: 7 days
- Carfilzomib: 7 days
- G-CSF: 14 days
- 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 or any other anti-CD38: 28 days
- Ixazomib: 7 day.
- 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).
- Received prior treatment with venetoclax.
- Plans to receive maintenance treatment within 60 days post- transplantation (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 CNS metastases or carcinomatous meningitis.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to motixafortide, G-CSF, or other agents used in the study.
- Has an active or uncontrolled infection requiring systemic therapy.
- Has a known additional malignancy that is progressing or requires active treatment.
- Is currently participating and/or 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...
- 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, CABG, coronary or cerebral artery stenting and/or angioplasty, stroke, cardiac surgery, or hospitalization for congestive heart failure within 3 months, Angina Pectoris Class \>2 or NYHA Heart...
- 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 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, within the projected duration of the trial...
- Known human immunodeficiency virus (HIV) or active Hepatitis B (e.g., Hepatitis B Surface Antigen [HBsAg] reactive and HBV DNA\>500 IU/mL or \>2500 copies/mL) or Hepatitis C (e.g., Hepatitis C Virus [HCV] RNA...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Harbin, Hei Longjiang, China
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, 18 years to 78 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Harbin, Hei Longjiang, China. 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 ClinicalTrials.gov; the study team decides eligibility.