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NCT03909412
Carfilzomib Based Chemotherapy Mobilization for Autologous Stem Cell Transplants in Multiple Myeloma
Conditions: Multiple Myeloma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 18
Sponsor: Hackensack Meridian Health
Location: Hackensack Meridian Health - John Theurer Cancer Center Hackensack New Jersey
Summary
This phase I study utilizes a 3+3 design with escalating cohorts of Carfilzomib at 20mg/m2, 27mg/m2, 36mg/m2, 45mg/m2, 56mg/m2, and 70mg/m2 to be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone and Granulocyte colony-stimulating factor (G-CSF)
Eligibility Criteria
INCLUSION CRITERIA Subject has voluntarily agreed to participate by giving written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. Informed Consent must be obtained prior to mobilization.
* 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 \
Source: ClinicalTrials.gov (NCT03909412). StuddyBuddy aggregates publicly available trial information.