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: EUCTR2016-003105-33-IT
• Lead Sponsor: HOVO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-16
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

Patients with diagnosis of symptomatic pPCL (see appendix A)
- 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 (FLC) > 100 mg/l) or proven plasmacytoma by biopsy)
- Age =18 years
- WHO-performance status 0-3 (but WHO=3 is allowed only when caused by pPCL and not by co-morbid conditions)
- Written informed consent
- Patient capable of giving informed consent (patient is legally, physically and mentally capable of giving consent)
- All men and women of childbearing potential should use adequate contraception during the study. Sperm could be frozen from
men with child wish before start of treatment
- Negative pregnancy test at entry (if applicable)
- Patient is willing and able to adhere to the requirements of the lenalidomide Pregnancy Prevention Program (PPP)
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 61
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

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 (NYHA classification II-IV, see appendix E)
- Severe pulmonary dysfunction
- Significant hepatic dysfunction (serum bilirubin or transaminases = 3.0
times normal level), unless related to pPCL
- Patients with GFR < 15 ml/min
- Known history of allergy to Capsidol (a cyclodextrin derivative used to solubilize carfilzomib)
- Previous chemotherapy or radiotherapy except local radiotherapy in case of local myeloma progression or corticosteroids maximum 7 days
for symptom control or stabilization(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