A Phase 2 Trial of Carfilzomib Consolidation After Autologous Stem Cell Transplantation for Multiple Myeloma(CARAMEL 2)
Inclusion Criteria:
- Creatinine =< 3 mg/dL
- Absolute neutrophil count >= 1,000/μL
- Platelet count >= 75,000/μL
- Hemoglobin >= 8.0 g/dL
- 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 the Mayo Clinic enrolling institution 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
- Bone marrow plasma cells >= 30%
- For patients with no relapse prior to transplant, measurable disease at the time of
diagnosis
- 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
- 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
Exclusion Criteria:
- 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