Carfilzomib Based Chemotherapy Mobilization for Autologous Stem Cell Transplants in Multiple Myeloma

Korábbi kezelés

• Subject has a NYHA Class III or IV heart disease and/or a history of active unstable angina, congestive heart disease, severe uncontrolled cardiac arrhythmia, electrocardiographic evidence of acute ischemia, active conduction system abnormalities or myocardial infarction within 6 months prior to enrollment. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
• Subject has received radiation therapy within 3 weeks of enrollment. Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy.
• Subject has had prior mobilization or stem cell transplant.

Más betegség

• Subject has a history of allergic reactions to compounds containing captisol, or Carfilzomib
• Uncontrolled hypertension.
• Pulmonary hypertension.
• Known HIV infection, hepatitis C infection (subjects with hepatitis C that achieve a sustained virologic response after antiviral therapy are allowed), or hepatitis B infection (subjects with hepatitis B surface antigen or core antibody that achieve sustained virologic response with antiviral therapy are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on the study).
• Subject has active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
• Subject has been diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.

Laborértékek

• Subject has concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable risk, including, but not limited to, uncontrolled hypertension, uncontrolled diabetes, active uncontrolled infection, and/or acute chronic liver disease (i.e., hepatitis, cirrhosis).

Egyéb

• Subject has ≥Grade 2 peripheral neuropathy.

• Subject has a confirmed diagnosis of multiple myeloma as specified by the International Myeloma Working Group criteria and must have measurable disease as defined by at least one of the following criteria:
• Serum monoclonal protein ≥ 0.5 g/dL
• ≥200 mg of monoclonal protein in the urine on 24-hour electrophoresis
• Serum immunoglobulin free light chain: involved FLC ≥ 10 mg/dL (≥ 100 mg/L) AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
• MRD positivity in peripheral blood by flow cytometry.
• Subject previously received treatment with Carfilzomib.
• Subject is ≥18 years of age at the time of signing the informed consent form.
• Subject has an ECOG performance status of < 2.
• Subjects must have completed any "induction therapy" and have achieved less than a CR.
• Subject has a life expectancy of >12 weeks.
  • Absolute neutrophil count (ANC) ≥1000 cells/mm3 (≥500 for patients with bone marrow biopsy displaying >50% involvement by myeloma)
  • Platelets count ≥ 50,000/mm3 (≥ 30,000 for patients with bone marrow biopsy displaying >50% involvement by myeloma)
  • Hemoglobin > 9.0 g/dL
  • Serum SGOT/AST <3.0 x upper limits of normal (ULN)
  • Serum SGPT/ALT <3.0 x upper limits of normal (ULN)
  • Serum total bilirubin <1.5 x ULN
• Subject must have a MUGA scan or echo with LVEF ≥40% within 6 months of enrollment.
• Females of childbearing potential (FCBP) must have a negative serum pregnancy test should be done within 7 days of treatment initiation and a negative urine pregnancy test within the 24 hours prior to the first study drug administration
• FCBP and male subjects who are sexually active with FCBP must agree to use 2 highly effective concomitant methods of contraception including a male condom during the study and for 90 days following the last dose of study treatment
• Male subjects must agree to not donate sperm while taking carfilzomib and for 90 days after the last dose of carfilzomib.