Single-Arm phase 2 trial evaluating efficacy of incorporating Daratumumab to treatment of newly diagnosed primary plasma cell leukemia. Treatment will be based on Dara-VRd induction followed by first ASCT, Dara-VRd for first consolidation, second ASCT, Dara-VRd for 1 year as second consolidation and Lenalidomide for 1 year.
Male or female patients 18 to 69 years old.
Patient with primary plasma cell leukemia disease as defined by the International Myeloma Working Group -IMWG (Annexe I)
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2.
Male or female patients <18 or > 69 years old
Prior history of malignancies, unless free of the disease for ≥ 5 years.
Prior history of symptomatic myeloma; did not received any previous chemotherapy for myeloma except corticotherapy (dexamethasone 40 mg/d for 4 days max).
Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation.
Single group
Daratumumab
DrugDaratumumab added to induction, first consolidation and second consolidation
VGPR or better at the completion of induction phase
The VGPR or better rate (as determined by the reviewer) is defined as the proportion of patients with confirmed IMWG criteria for VGPR, CR or stringent CRrelative to the total number of patients in the ITT population
Progression Free Survival
Response rates (sCR, CR, VGPR, PR, SD):
Response rates (sCR, CR, VGPR, PR, SD):
Response rates (sCR, CR, VGPR, PR, SD):
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