Tests a carfilzomib-based treatment to collect stem cells before transplant in myeloma

Trial details

Who runs it

Hackensack Meridian Health

Trial code

NCT03909412

Record updated

21 September 2026

Original description

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)Read full original descriptionShow less

Phase I Study of Carfilzomib-based Chemotherapy Mobilization for Autologous Stem Cell Transplantation in Multiple Myeloma

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)

Inclusion: 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.

Exclusion: 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; 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; 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); Subject has ≥Grade 2 peripheral neuropathy.

ClinicalTrials.gov NCT03909412