Waldenström's Macroglobulinemia MedDRA version: 21.0 Level: PT Classification code 10047801 Term: Waldenstrom's macroglobulinaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Imbruvica
Product Name: Imbruvica
Product Code: [Imbruvica]
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ibrutinib
CAS Number: 936563-96-1
Current Sponsor code: Imbruvica
Other
Sponsors
UNIVERSITäTSKLINIK ULM
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Proven clinicopathological diagnosis of WM as defined by consensus panel one of the Second IWWM4. • De novo or relapsed / refractory WM independent of the genotype. • Patients must have at least one of the following criteria to start study treatment as as defined by the protocol criteria. • World Health Organization (WHO) / ECOG performance status = 2. • Left ventricular ejection fraction = 40% as assessed by transthoracic echocardiogram (TTE). • Age = 18 years (male and female), • Life expectancy > 3 months in the opinion of the investigator, adequate laboratory values. • Baseline platelet count = 50 x109/L, absolute neutrophil count = 0.75 x 109/L (if not due to BM infiltration by the lymphoma). • Meet the following pre-treatment laboratory criteria at the screening visit conducted within 30 days prior to randomization: ¿ ASAT (SGOT): =65 years) yes F.1.3.1 Number of subjects for this age range 92
Exclusion criteria
Exclusion criteria: • Previous treatments with following substances Prior exposure to Ibrutinib or other BTK inhibitors and Prior exposure to Carfilzomib • Serious medical or psychiatric illness • Active HIV, HBV or HCV infection • Central Nervous System involvement by lymphoma. • History of a non-lymphoid malignancy except • Uncontrolled illness including, but not limited to. (See the protocol). • Recent major surgery within 30 days prior to randomization. • Known cirrhosis • Approved or investigational anticancer treatment within 21 days prior to randomization. • Glucocorticoid therapy within 14 days prior to randomization • Focal radiation therapy within 7 days prior to randomization. • Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs. • Hypersensitivity to the active substances or to any of the excipients of the investigational medicinal products • Active infection • Ascites • Uncontrolled hypertension • History of stroke or intracranial hemorrhage • Known interstitial lung disease. • Pleural effusions. • Infiltrative pulmonary disease, known pulmonary hypertension. • Known chronic obstructive pulmonary• • Known severe persistent asthma • Autologous or allogeneic stem cell transplant less • Vaccination with • Patients who require strong or moderate inducers or inhibitors for cytochrome • Patients who have an uncontrolled bleeding disorder or require an anticoagulant • History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or sponsor, if consulted, would pose a risk to patient safely or interfere with the study evaluation, procedures or completion. • Patient is a woman who is pregnant or breastfeeding (and do not consent to discontinue breast-feeding) or planning to become pregnant while enrolled in this study or within 6 months after the last study treatment. • Vulnerable patients, e.g. patients who are incapable of giving informed consent (severe dementia or psychosis, patients kept in detention). • Participation in another interventional clinical study within 30 days before randomization in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to explore the efficacy of Carfilzomib in combination with Ibrutinib compared to Ibrutinib alone in patients with treatment naïve or relapsed WM.;Secondary Objective: Response rate (CR, VGPR, PR, MR) 12 and 24 months after the start of treatment Best response Time to best response Time to first response Time to treatment failure, Remission Duration Progression free survival Cause specific survival Overall survival Safety Quality of life;Primary end point(s): The aim of this study is to investigate the rate of CR or VGPR 12 months after the start of treatment using the response criteria updated at the Sixth IWWM (CR/VGPR).;Timepoint(s) of evaluation of this end point: After 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Response rate (CR, VGPR, PR, MR) and ORR (CR, VGPR, PR) 12 and 24 months after the start of treatment Best response Time to best response Time to first response Time to treatment failure Remission Duration Progression free survival Cause specific survival Overall survival Safety Quality of life;Timepoint(s) of evaluation of this end point: after 12 and 24 months | — |
Countries
Austria, European Union, Germany, Greece, Italy
Contacts
Public ContactChristian Buske
University Hospital Ulm
Outcome results
None listed