A MULTICENTER, OPEN LABEL PHASE II STUDY OF CARFILZOMIB, CYCLOPHOSPHAMIDE AND DEXAMETHASONE IN NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS - CCD

Phase 1

Active, not recruiting

• Conditions: newly diagnosed multiple myeloma patients; MedDRA version: 13.1Level: HLTClassification code 10028229Term: Multiple myelomasSystem Organ Class: 10005329 - Blood and lymphatic system disorders

• Registration Number: EUCTR2010-021111-17-IT
• Lead Sponsor: HOVON Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-26
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

- Patient is of a legally consenting age as defined by local regulations. - Patient is age = 65 year of age or who are ineligible for autologous stem cell transplantation. - Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements. - Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care. - Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. - Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) for the duration of the study. - Patient is a newly diagnosed MM patient. - Patient has measurable disease, defined as follows: any quantifiable serum monoclonal protein value (generally, but not necessarily, = 0.5 g/dL of M-protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours. For patients with oligo or non-secretory MM, it is required that they have measurable plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan) or an abnormal free light chain ratio (n.v.: 0.26-1.65). We anticipate that less than 10% of patients admitted to this study will be oligo- or non-secretory MM with free light chains only in order to maximize interpretation of benefit results. - Patient has a Karnofsky performance status =60%. - Patient has a life-expectancy >3 months. - Patient has the following laboratory values within 14 days before Baseline (day 1 of the Cycle 1, before study drug administration): - Platelet count =50 x 109/L (=30 x 109 /L if myeloma involvement in the bone marrow is > 50%) within 14 days prior to drug administration). - Absolute neutrophil count (ANC) = 1 x 109/L without the use of growth factors. - Corrected serum calcium =14 mg/dL (3.5 mmol/L) - Alanine transaminase (ALT): = 3 x the ULN. - Total bilirubin: = 2 x the ULN. - Calculated or measured creatinine clearance: = 15 mL/minute
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients with non-secretory MM, unless serum free light chains are present and the ratio is abnormal. - Pregnant or lactating females - Patient has active infectious hepatitis type B or C or HIV. - Patients with myocardial infarction or unstable angina = 4 months or other clinically significant heart disease (e.g., CHF NY Heart Association class III or IV, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen) - Peripheral neuropathy > CTCAE grade 2 and = grade 2 painful peripheral neuropathy (with the difference being in the exclusion of patients with Grade 2 painful PN). - Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib) - Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preeexisting pulmonary or cardiac impairment. - Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to baseline; - Patient has any other clinically significant illness that would, in the investigator’s opinion, increase the patient’s risk for toxicity. - Patients with a prior malignancy within the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix or breast, or localized prostate cancer of Gleason score <7 with a stable PSA).

Study & Design

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