Carfilzomib and Dexamethasone in Treating Patients With Multiple Myeloma Who Previously Underwent a Stem Cell Transplant
NCT ID: NCT01812720
Last Updated: 2016-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2013-08-31
2014-10-31
Brief Summary
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Detailed Description
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I. To assess the complete response (CR) rate with carfilzomib and dexamethasone consolidation following an upfront single stem cell transplant (SCT).
SECONDARY OBJECTIVES:
I. To assess the toxicity of carfilzomib and dexamethasone when used as consolidation therapy in patients post SCT.
II. To determine the progression free rate at 1 and 2 years post SCT. III. To evaluate progression-free survival and overall survival.
TERTIARY OBJECTIVES:
I. To determine the proportion of patients achieving a minimal residual disease (MRD) negative status.
II. To assess the HevyLite assay prior to and during treatment.
OUTLINE:
Patients receive carfilzomib intravenously (IV) over 30 minutes and dexamethasone orally (PO) on days 1, 2, 15, and 16. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up every 3 months for 3 years and then every 6 months for 2 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (carfilzomib, dexamethasone)
Patients receive carfilzomib IV over 30 minutes and dexamethasone PO on days 1, 2, 15, and 16. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
carfilzomib
Given IV
dexamethasone
Given PO
laboratory biomarker analysis
Correlative studies
Interventions
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carfilzomib
Given IV
dexamethasone
Given PO
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Absolute neutrophil count \>= 1,000/uL
* Platelet count \>= 75,000/uL
* Hemoglobin \>= 8.0 g/dL
* Previous diagnosis of symptomatic multiple myeloma (MM)
* Received single autologous stem cell transplantation 60-120 days prior to registration
* Received the autologous SCT =\< 12 months of their diagnosis of myeloma to be eligible for the study
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
* Recovered from toxicity of previous chemotherapy (excludes grade 1 neurotoxicity and hematological toxicity)
* Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that the subject may withdraw consent at any time without prejudice to future medical care
* Negative pregnancy test performed =\< 7 days prior to registration, for women of childbearing potential only
* Willingness to return to one of the enrolling institutions for follow-up (during the active monitoring phase of the study); NOTE: during the active monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up
* Measurable disease of multiple myeloma at the time of baseline values for disease assessment as defined by at least one of the following:
* Serum monoclonal protein \>= 1.0 g/dL
* \>= 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
* Serum immunoglobulin free light chain \>= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
* NOTE: for patients with no relapse prior to transplant, measurable disease at the time of diagnosis
* NOTE: for patients who have had a disease relapse prior to transplant, measurable disease at the time of the most recent relapse immediately prior to transplant; NOTE: if the patient had treatment for the relapsed disease prior to transplant, the patient must have measurable disease at the time of relapse prior to this therapy
* Willing to provide bone marrow and blood samples for correlative research purposes
Exclusion Criteria
* Evidence of disease progression post SCT at the time of consideration for the study enrollment
* Myocardial infarction =\< 6 months prior to registration
* New York Heart Association (NYHA) class III or IV heart failure
* Uncontrolled angina
* Severe uncontrolled ventricular arrhythmias
* Electrocardiographic (ECG) evidence of acute ischemia or active conduction system abnormalities; NOTE: prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant
* Seroreactivity for human immunodeficiency virus (HIV), human T-cell lymphotrophic virus (HTLV) I or II, hepatitis B virus (HBV), or hepatitis C virus (HCV)
* Other active malignancy requiring therapy; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer
* Pregnant women or women of reproductive capability who are unwilling to use effective contraception
* Nursing women
* Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 28 days after stopping treatment
* Other co-morbidity, which would interfere with patient's ability to participate in the trial, e.g. uncontrolled infection, uncompensated lung disease
* Concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
* Known allergies to any of the components of the investigational treatment regimen or required ancillary treatments
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Shaji Kumar
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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City of Hope
Duarte, California, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Other Identifiers
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NCI-2013-00492
Identifier Type: REGISTRY
Identifier Source: secondary_id
12-005975
Identifier Type: -
Identifier Source: secondary_id
MC1287
Identifier Type: OTHER
Identifier Source: secondary_id
MC1287
Identifier Type: -
Identifier Source: org_study_id