S1304, Carfilzomib and Dexamethasone for Treating Patients With Relapsed or Refractory Myeloma

Completed · Phase 2

Conditions studied: Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma

In brief

This randomized phase II trial compares how well two different doses of carfilzomib work when given with dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement or has not responded to treatment. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carfilzomib together with dexamethasone may kill more cancer cells. It is not yet known whether a higher or lower dose of carfilzomib works better when given with dexamethasone.

Key facts

Study ID

NCT01903811

Run by

SWOG Cancer Research Network

People needed

143

Starts

2013-10-01

Expected to finish

2019-03-07

Last updated by the study team

2024-12-20

Who can join

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

You may qualify if…

• REGISTRATION STEP 1: INITIAL RANDOMIZATION
• Patients must have a confirmed diagnosis of symptomatic multiple myeloma and must be currently relapsed or refractory; all tests for establishing disease status must be completed within 28 days prior to registration and documented on the Baseline Tumor Assessment Form for Multiple Myeloma
• Patients must have measurable disease within 28 days prior to registration
• Patients must have received at least one prior regimen of chemotherapy for symptomatic multiple myeloma; patients may not have more than six (6) previous regimens of therapy for the disease; prior chemotherapy must have been completed at least 21 days prior to registration; for study purposes, a regimen is defined as follows:
• An anti-myeloma therapy used at the time of initial diagnosis or documented disease progression which is given with the intent to decrease disease burden
• Any maintenance therapy used after an Induction should be considered part of that Induction regimen
• Use of any agent or combination of agents more than once during the patient's disease history for separate documented disease progressions will be counted as separate regimens (e.g., if a patient receives lenalidomide/bortezomib at initial diagnosis and achieves response, but then progresses and receives lenalidomide/bortezomib after progression, these count as 2 separate regimens)
• In cases of allogeneic or autologous stem cell transplant, the entire induction + stem cell mobilization + conditioning + planned maintenance should be considered one regimen
• Patients may not have received any prior carfilzomib treatment
• Patients must not be receiving any other concurrent therapy considered to be investigational; patients must not be planning to receive any radiotherapy (except localized radiation for palliative care); patients must not be planning to receive any concurrent chemotherapy, immunotherapy, radiotherapy or other treatment with curative intent
• Patients must have complete history and physical examination within 28 days prior to registration
• Patients must have baseline PET scan within 28 days prior to registration; note that images are submitted centrally for review
• Patients with non-secretory MM or known primary amyloidosis are not eligible
• Patients must have Zubrod performance status 0-2
• Patients must not have clinically significant illness including uncontrolled, active infection requiring intravenous antibiotics, New York Heart Association (NYHA) class III or class IV heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, or >= grade 3 cardiac arrhythmias
• Patients must have undergone an electrocardiogram (EKG) within 28 days prior to registration
• Patients must have either echocardiogram (ECHO) with ejection fraction >= 45% within 28 days prior to registration
• Patients must not have > grade 2 neuropathy and/or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
• Total bilirubin =< 1.5 x upper limit of normal (ULN)
• Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =< 3 x ULN
• Absolute neutrophil count (ANC) >= 1,000 cell/mm\^3 without growth factor support within 14 days prior to registration
• Platelets >= 50,000 cells/mm\^3 for patients who have bone marrow plasmacytosis < 50% or >= 30,000 cells/mm\^3 for patients who have bone marrow plasmacytosis of >= 50% within 14 days prior to registration
• Calculated or measured creatinine clearance >= 30 ml/min within 14 days prior to registration
• Patients who are known to be human immunodeficiency virus positive (HIV+) are eligible providing they meet all of the following additional criteria within 28 days prior to registration:
• Cluster of differentiation (CD)4 cells >= 500/mm\^3

Where it is running

• University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
• The University of Arizona Medical Center-University Campus — Tucson, Arizona, United States
• Kaiser Permanente-Anaheim — Anaheim, California, United States
• Kaiser Permanente-Deer Valley Medical Center — Antioch, California, United States
• Sutter Auburn Faith Hospital — Auburn, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California, United States
• Kaiser Permanente-Baldwin Park — Baldwin Park, California, United States
• Kaiser Permanente-Bellflower — Bellflower, California, United States
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• Mills - Peninsula Hospitals — Burlingame, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California, United States
• Eden Hospital Medical Center — Castro Valley, California, United States
• John Muir Medical Center-Concord Campus — Concord, California, United States
• Sutter Davis Hospital — Davis, California, United States
• Kaiser Permanente Hospital — Fontana, California, United States
• Kaiser Permanente-Fremont — Fremont, California, United States
• Kaiser Permanente — Fresno, California, United States
• Kaiser Permanente - Harbor City — Harbor City, California, United States
• Kaiser Permanente-Irvine — Irvine, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• Los Angeles County-USC Medical Center — Los Angeles, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Kaiser Permanente-Cadillac — Los Angeles, California, United States
• Fremont - Rideout Cancer Center — Marysville, California, United States
• Fairbanks Memorial Hospital — Fairbanks, Alaska, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.