Carfilzomib and lenalidomide-based treatment for younger and elderly newly diagnosed primary plasma cell leukemia patients

Phase 1

• Conditions: Primary plasma cell leukemia; MedDRA version: 20.0Level: LLTClassification code 10035223Term: Plasma cell leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2013-005157-75-GB
• Lead Sponsor: HOVO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-03
• Last Update Posted: 25 August 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

? Patients with diagnosis of symptomatic pPCL
? Measurable disease as defined by the presence of M-protein in serum or urine (serum M-protein >10 g/l or urine M-protein >200 mg/24 hours or abnormal FLC ratio with involved free light chain >100 mg/l) or proven plasmacytoma by biopsy)
? Age =18 years
? WHO-performance status 0-3
? Written informed consent
? Patient capable of giving informed consent
? All men and women of childbearing potential should use adequate contraception during the study.
? Negative pregnancy test at entry (if applicable)
? Patient is willing and able to adhere to the requirements of the lenalidomide Pregnancy Prevention Program.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

? Any current CNS involvement with disease refractory to intrathecal chemotherapy.
? Female patients who are pregnant or breast feeding.
? HIV positive patients
? Active malignancy other than pPCL requiring treatment, or a malignancy that has been treated with chemotherapy currently affecting bone marrow capacity
? Patients with active, uncontrolled infections
? Severe neurological or psychiatric disease
? Severe cardiac dysfunction
? Severe pulmonary dysfunction
? Significant hepatic dysfunction, unless related to pPCL
? Patients with GFR <15 ml/min
? Known history of allergy to Capsidol
? Hypersensitivity to the active substances (carfilzomib, lenalidomide and dexamethasone)or to any of the excipients of these drug products
? Previous chemotherapy or radiotherapy, except local radiotherapy in case of local myeloma progression or corticosteroids maximum 7 days for symptom control or stabilisation (this includes dexamethasone 40 mg daily) or inthrathecal chemotherapy in case of CNS involvement
? Systemic AL amyloidosis
? Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified