Mobilization of Stem Cells With Motixafortide (BL-8040) in Combination With G-CSF in Multiple Myeloma Patients

Phase 3

Not yet recruiting

• Conditions: Multiple Myeloma
• Interventions: Drug: Motixafortide+G-CSF; Drug: Placebo+G-CSF

• Registration Number: NCT06514508
• Lead Sponsor: Guangzhou Gloria Biosciences Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-16
• Last Update Submitted: 2024-07-16
• Study First Posted: 2024-07-23
• Last Update Posted: 2024-07-23
• Study Start: 2024-09-30
• Primary Completion: 2026-08-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Motixafortide+G-CSF	Motixafortide+G-CSF	-
Placebo+G-CSF	Placebo+G-CSF	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients mobilizing ≥6.0 × 10^6 CD34+ cells/kg with up to 2 apheresis sessions	Up to day 6

Secondary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax)	Up to Day 8
Time from transplantation to neutrophil engraftment	Up to post transplantation Day 29
Time from transplantation to platelets engraftment	Up to post transplantation Day 29
Number of CD34+ cells/kg collected	Up to Day 8
Proportion of patients who collect ≥6.0 × 10^6 CD34+ cells/kg in 1 apheresis session	Up to Day 5
Proportion of patients who collect ≥2.0 × 10^6 CD34+ cells/kg in 1 apheresis session	Up to Day 5
Change from Baseline in peripheral blood CD34+ cell concentration	Up to Day 8
Incidence of adverse events (AEs) and serious adverse events (SAEs)	Up to Day 38
Graft durability at 100 days post-transplantation	Up to post transplantation Day 100	Graft durability is defined as maintenance of at least 2 of the following 3 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.; * Absolute neutrophil count (ANC) ≥1.0 × 10\^9/L for 1 week.

Trial Locations

Locations (2)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Harbin The First Hospital; 🇨🇳 Harbin, Hei Longjiang, China