ConditionMultiple Myeloma
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 groupsSponsors and collaborators
Source ClinicalTrials.gov