PRIMARY PLASMA CELL LEUKEMIA: A PROSPECTIVE PHASE II STUDY INCORPORATING DARATUMUMAB TO CHEMOTHERAPY AND STEM CELL TRANSPLANTATION
Conditions
Brief summary
The primary endpoint is the VGPR or better rate at the completion of induction phase (according to the IMWG response criteria)
Detailed description
Progression-free Survival, Overall Survival, Time to progression and Duration of Response, overall hematological response rates, Assess safety by type, frequency, severity, relationship of adverse events to study treatment and changes in vital signs, physical exams. Incidence of Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE) and laboratory abnormalities using National Cancer Institute (NCI) common toxicity criteria (CCTAE V4)., Evaluate response according to chromosomal structural abnormalities such as del(17p), t(4;14), t(11;14), t(14;16), t(14;20), amp(1q) and del(1p), Minimal residual disease (MRD) assessed by NGS, Quality of life (EORTC QLQ-C30 domain scores)
Interventions
DRUGRevlimid 5 mg hard capsules
DRUGDEXAMETHASONE
DRUGDARZALEX 1800 mg solution for injection
DRUGBORTEZOMIB
DRUGRevlimid 10 mg hard capsules
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the VGPR or better rate at the completion of induction phase (according to the IMWG response criteria) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival, Overall Survival, Time to progression and Duration of Response, overall hematological response rates, Assess safety by type, frequency, severity, relationship of adverse events to study treatment and changes in vital signs, physical exams. Incidence of Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE) and laboratory abnormalities using National Cancer Institute (NCI) common toxicity criteria (CCTAE V4)., Evaluate response according to chromosomal structural abnormalities such as del(17p), t(4;14), t(11;14), t(14;16), t(14;20), amp(1q) and del(1p), Minimal residual disease (MRD) assessed by NGS, Quality of life (EORTC QLQ-C30 domain scores) | — |
Countries
France
Outcome results
None listed