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Trial Title:
Mobilization of Stem Cells With Motixafortide (BL-8040) in Combination With G-CSF in Multiple Myeloma Patients
NCT ID:
NCT06514508
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Lenograstim
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Motixafortide+G-CSF
Description:
Patients will receive the first dose of motixafortide (1.25 mg/kg) by subcutaneous (SC)
injection on the evening of Day 4 (10 to 14 hours) prior to initiation of the first
apheresis. A second dose of motixafortide can be administered 10 to 14 hours before a
third apheresis, if necessary for patients who did not reach the goal of collection.
Injections of G-CSF per standard of care.
Arm group label:
Motixafortide+G-CSF
Other name:
BL-8040+G-CSF
Intervention type:
Drug
Intervention name:
Placebo+G-CSF
Description:
Patients will receive the first dose of placebo by subcutaneous (SC) injection on the
evening of Day 4 (10 to 14 hours) prior to initiation of the first apheresis. A second
dose of placebo can be administered 10 to 14 hours before a third apheresis, if necessary
for patients who did not reach the goal of collection. Injections of G-CSF per standard
of care.
Arm group label:
Placebo+G-CSF
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- (Limit: 15,000 characters)
1. Patients must have a signed study informed consent prior to entering the study.
2. Patients must be between the ages of 18 and 78 years.
3. Diagnosis of active multiple myeloma (aMM) as defined by IMWG criteria.
4. 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.
5. Eligible for Autologous Hematopoietic stem cell transplantation according to
the Investigator's discretion.
6. The subjects should be in first or second CR (including CR and SCR) or PR
(including PR and VGPR).
7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
8. Adequate organ function at screening.
9. Female subjects 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 administration. Women
of childbearing potential (WOCBP) and male subjects with WOCBP partners must
agree to use highly effective contraception method during the study period and
within 90 days after the last study treatment.
Exclusion Criteria:
1. Previous history of autologous or allogeneic-HCT.
2. Failed previous 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. Pamolidomide: 7 days
5. Bortezomib: 7 days
6. Carfilzomib: 7 days
7. G-CSF: 14 days
8. 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 or any other anti-CD38: 28 days
13. Ixazomib: 7 day.
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).
8. Received prior treatment with venetoclax.
9. Plans to receive maintenance treatment within 60 days post- transplantation
(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 CNS metastases or carcinomatous meningitis.
12. 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.
13. Has an active or uncontrolled infection requiring systemic therapy.
14. Has a known additional malignancy that is progressing or requires active treatment.
15. 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 treatment.
16. O2 saturation < 92% (on room air).
17. Personal history or family history of Long QT Syndrome or Torsade de Pointes.
18. History of unexplained syncope, syncope from an uncorrected cardiac etiology, or
family history of sudden cardiac death.
19. 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 Failure Class >2.
20. ECG at screening showing QTcF > 470 msec and/or PR > 280 msec.
21. 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.
22. Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.
23. 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, starting with the
Screening Visit through 90 days after the last dose of study drug.
24. 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 [qualitative] is positive).
25. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
78 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Zip:
100044
Country:
China
Contact:
Last name:
Xiaojun Huang, M.D.
Phone:
+86-13701389625
Email:
xjhrm@medmail.com.cn
Facility:
Name:
Harbin The First Hospital
Address:
City:
Harbin
Zip:
150010
Country:
China
Contact:
Last name:
Jun Ma, M.D.
Phone:
+86-0451-84883471
Email:
majun0322@126.com
Start date:
September 30, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Guangzhou Gloria Biosciences Co., Ltd.
Agency class:
Industry
Source:
Guangzhou Gloria Biosciences Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06514508