Carfilzomib and Lenalidomide With Dexamethasone Combination in Newly Diagnosed, Previously Untreated Multiple Myeloma

Completed · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

This study is designed to evaluate the safety and to determine the maximum tolerated dose of carfilzomib + lenalidomide in combination with dexamethasone in newly diagnosed Multiple Myeloma patients who have not received treatment.

Key facts

Study ID

NCT01029054

Run by

University of Michigan Rogel Cancer Center

People needed

53

Starts

2009-09-01

Expected to finish

2015-07-01

Last updated by the study team

2017-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed, histologically confirmed, previously untreated Stage I, II, or III multiple myeloma requiring systemic chemotherapy
• Diagnosis of symptomatic multiple myeloma per IMWG uniform criteria within the past 90 days
• Measurable disease, per IMWG (International Myeloma Working Group) criteria (>= one of the following) within the past 4 weeks:
• Monoclonal protein >= 0.5 g/dL by serum protein electrophoresis
• Monoclonal light chain >= 200 mg by 24-hour urine protein electrophoresis
• If serum protein electrophoresis is felt to be unreliable for routine M-protein measurement, then quantitative immunoglobulin levels are acceptable
• Life expectancy > 3 months
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Adequate hepatic function, with bilirubin < 1.5 x the ULN, and AST (Aspartate Aminotransferase) and ALT (Alanine Transaminase) < 2.5 x ULN
• Absolute neutrophil count (ANC) >=1.0 x 109/L, hemoglobin >= 8 g/dL, platelet count >= 75 x 109/L
• Calculated creatinine clearance (by Cockroft-Gault) >= 60 ml/min
• Written informed consent in accordance with federal, local, and institutional guidelines.
• Subjects must agree to adhere to all study requirements, including birth control measures and pregnancy testing, visit schedule, outpatient treatment, required concomitant medications, and laboratory monitoring.
• Must be able to take either 81 mg or 325 mg aspirin daily as prophylactic anticoagulation.

You may not qualify if…

• Non-secretory or hyposecretory multiple myeloma, defined as <0.5 g/dL M-protein in serum, <200 mg/24 hr urine M-protein, or disease only measured by serum free light chain
• POEMS (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal Gammopathy, and Skin Changes) syndrome
• Plasma cell leukemia
• Waldenström's macroglobulinemia or IgM myeloma
• Radiotherapy to multiple sites or immunotherapy within 2 weeks before start of protocol treatment (localized radiotherapy to a single site at least 1 week before start is permissible)
• Patient must not have been previously treated with any prior systemic therapy for the treatment of multiple myeloma
• Prior treatment of hypercalcemia or spinal cord compression or aggressively progressing myeloma with corticosteroids does not disqualify the patient (the dose should not exceed the equivalent of 160 mg of dexamethasone in a 2 week period)
• Bisphosphonates are permitted
• Participation in an investigational therapeutic study within 3 weeks or within 5 drug halflives (t1/2) prior to first dose, whichever time is greater
• Pregnant or lactating females
• History of allergy to mannitol
• Major surgery within 3 weeks prior to first dose
• Myocardial infarction within 3 months prior to enrollment, NYHA (New York Heart Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
• Uncontrolled hypertension or diabetes
• Acute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose
• Known or suspected HIV infection, known HIV seropositivity
• Active hepatitis infection
• Non-hematologic malignancy within the past 3 years except a) adequately treated basal cell, squamous cell skin cancer, thyroid cancer, carcinoma in situ of the cervix, or prostate cancer < Gleason Grade 6 with stable prostate specific antigen levels or cancer considered cured by surgical resection alone
• Any clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
• Significant neuropathy (Grade >2) at the time of the first dose and/or within 14 days before enrollment
• Contraindication to any of the required concomitant drugs
• Subjects in whom the required program of PO and IV fluid hydration is contraindicated
• Subjects with known or suspected amyloidosis of any organ
• Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis

Where it is running

• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Mt. Sinai Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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