Trial Details

Trial status:

In follow-up (non-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

Note: For enquiries only. DO NOT use for clinical referrals.

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

Contact the trial team

View trial documents

Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

View map

Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899

CTC staff

University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000