Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma

Completed · Phase 3

Conditions studied: Relapsed Multiple Myeloma

In brief

The primary objective was to compare progression-free survival in adults with relapsed multiple myeloma who are receiving CRd vs participants receiving Rd in a randomized multicenter setting.

Key facts

Study ID

NCT01080391

Run by

Amgen

People needed

792

Starts

2010-07-14

Expected to finish

2017-12-05

Last updated by the study team

2022-09-21

Who can join

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

You may qualify if…

• Symptomatic multiple myeloma
• Measurable disease, as defined by one or more of the following (assessed within 21 days prior to randomization):
• Serum M-protein ≥ 0.5 g/dL
• Urine Bence-Jones protein ≥ 200 mg/24 hours
• For immunoglobulin A (IgA) patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) ≥ 750 mg/dL (0.75 g/dL)
• Prior treatment with at least one, but no more than three, regimens for multiple myeloma
• Documented relapse or progressive disease on or after any regimen
• Achieved a response to at least one prior regimen
• Age ≥ 18 years
• Life expectancy ≥ 3 months
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Adequate hepatic function, with serum alanine aminotransferase (ALT) ≤ 3.5 times the upper limit of normal and serum direct bilirubin ≤ 2 mg/dL (34 µmol/L) within 21 days prior to randomization
• Absolute neutrophil count ≥ 1.0 × 10\^9/L within 21 days prior to randomization
• Hemoglobin ≥ 8 g/dL (80 g/L) within 21 days prior to randomization
• Platelet count ≥ 50 × 10\^9/L (≥ 30 × 10\^9/L if myeloma involvement in the bone marrow is > 50%) within 21 days prior to randomization
• Creatinine clearance (CrCl) ≥ 50 mL/minute within 21 days prior to randomization
• Written informed consent in accordance with federal, local, and institutional guidelines
• Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception
• Male subjects must agree to practice contraception

You may not qualify if…

• If previously treated with bortezomib (alone or in combination), progression during treatment
• If previously treated with a lenalidomide and dexamethasone (len/dex) combination:
• Progression during the first 3 months of initiating treatment
• Any progression during treatment if the len/dex combination was the subject's most recent line of therapy
• Discontinuation of previous lenalidomide or dexamethasone due to intolerance; subjects intolerant to bortezomib are not excluded
• Prior carfilzomib treatment
• POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
• Waldenström's macroglobulinemia or IgM myeloma
• Plasma cell leukemia (> 2.0 × 10\^9/L circulating plasma cells by standard differential)
• Chemotherapy or investigational agent within 3 weeks prior to randomization or antibody therapy within 6 weeks prior to randomization
• Radiotherapy to multiple sites or immunotherapy/antibody therapy within 28 days prior to randomization; localized radiotherapy to a single site within 7 days prior to randomization
• Corticosteroid therapy at a dose equivalent to dexamethasone > 4 mg/day within 21 days prior to randomization
• Pregnant or lactating females
• Major surgery within 21 days prior to randomization
• Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to randomization
• Known human immunodeficiency virus infection
• Active hepatitis B or C infection
• Myocardial infarction within 4 months prior to randomization, New York Hear Association (NYHA) Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker
• Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to randomization
• Other malignancy, including myelodysplastic syndromes (MDS), within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
• Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to randomization
• 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 preexisting pulmonary or cardiac impairment
• Ongoing graft-vs-host disease
• Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to randomization

Where it is running

• Providence St. Joseph Medical Center — Burbank, California, United States
• St. Jude Hospital Yorba Linda dba; St. Joseph Heritage Healthcare — Santa Rosa, California, United States
• Stanford University — Stanford, California, United States
• Colorado Blood Cancer Institute — Denver, Colorado, United States
• Cancer and Blood Disease Center — Lecanto, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Indiana University Health Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• University of Kansas Cancer Center — Kansas City, Kansas, United States
• The University of Michigan - Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
• NYU Clinical Cancer Center — New York, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• Associates in Oncology and Hematology — Chattanooga, Tennessee, United States
• The Don & Sybil Harrington Cancer Center — Amarillo, Texas, United States
• Baylor Sammons Cancer Center — Dallas, Texas, United States
• UT Southwestern Medical Center at Dallas — Dallas, Texas, United States
• The University of Texas, MD Anderson Cancer Center — Houston, Texas, United States
• Scott and White Memorial Hospital — Temple, Texas, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
• Froedtert & Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Medizinische Universitat Wien — Vienna, Austria
• Wilhelminspital der Stadt Wien, Zentrum fur Onkologie und Hamatologie — Vienna, Austria
• Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg — Antwerp, Belgium
• Mayo Clinic — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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