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Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
14/12/2020
Funder:
Sponsor:
.
Chief Investigator:
Dr Reuben Benjamin (UK) / Niels van de Donk (EU)
Recruitment target:
4 (Max)
EudraCT number:
2013-005157-75
Contact details:
ctc.hovon129@ucl.ac.uk
Lay summary:
EMN12/HO129 pPCL
Carfilzomib and lenalidomide-based treatment for younger and elderly newly diagnosed primary plasma cell leukemia patients. A European Intergroup Trial of the European Myeloma Network (EMN)
Description
Design: Phase 2, prospective, multicenter trial. 
Treatment:
Patients with age 18-65 years will receive 4 cycles of carfilzomib, lenalidomide and dexamethasone (CRd) followed by HDM and auto-SCT, then consolidation therapy with 2 cycles of CRd, and subsequently, if eligible, and a suitable donor is available, then allo-SCT, the latter involving semi-intensive conditioning with busulfan + fludarabine. After allo-SCT patients will receive carfilzomib maintenance. Eight months after allo-SCT lenalidomide will be added to carfilzomib maintenance. The immunomodulatory agent lenalidomide is added at a later stage after allo-SCT in order to prevent the development of GvHD.
In case no donor can be identified OR if patient is ineligible to proceed with allo-SCT after the first auto-SCT OR if patient does not want to undergo allo-SCT, a second course of high dose melphalan and auto-SCT will be administered between 2 and 3 months after the first course when the patient achieved at least PR. This will be followed by 4 cycles CRd consolidation and subsequently carfilzomib-lenalidomide maintenance.

Patients with age ≥66 years will receive 8 cycles of CRd followed by carfilzomib-lenalidomide maintenance until progression.
Key inclusion/exclusion criteria:
Main inclusion criteria for registration:
Patients will have symptomatic pPCL, previously untreated, 
ISS stages I-III, 
Age ≥18 years
Main exclusion criteria for registration:
Active malignancy other than pPCL requiring treatment, or a malignancy that has been treated with chemotherapy currently affecting bone marrow capacity,
Female patients who are pregnant or breastfeeding,
Patient has severe cardiac, pulmonary or hepatic dysfunction or GFR
Duration of recruitment: 4 years
Aim
To evaluate progression-free survival in adult pPCL patients by incorporation of carfilzomib and lenalidomide into induction, consolidation, and maintenance therapy
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
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London
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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
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