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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-78
SponsorGuangzhou Gloria Biosciences Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

(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.

Disqualifiers

Previous history of autologous or allogeneic-HCT.

Failed previous HSC collections or collection attempts.

Dexamethasone: 7 days

Thalidomide: 7 days

Trial design

Treatments tested in this trial

  • Motixafortide+G-CSF
  • Placebo+G-CSF

Treatment groups

60 Participants
are divided into 2 treatment groups