Status:
WITHDRAWN
Carfilzomib and Dexamethasone in Treating Patients With Multiple Myeloma Who Previously Underwent a Stem Cell Transplant
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Refractory Multiple Myeloma
Stage I Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies how well carfilzomib and dexamethasone work in treating patients with multiple myeloma who previously underwent a stem cell transplant. Carfilzomib may stop the growth of c...
Detailed Description
PRIMARY OBJECTIVES: 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...
Eligibility Criteria
Inclusion
- Creatinine =\< 3 mg/dL
- 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
- Prior allogeneic bone marrow/peripheral blood stem cell transplant
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01812720
Start Date
August 1 2013
End Date
October 1 2014
Last Update
December 19 2016
Active Locations (3)
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1
City of Hope
Duarte, California, United States, 91010
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
Washington University School of Medicine
St Louis, Missouri, United States, 63110