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

Who is this study for? Patients with Multiple Myeloma
What treatments are being studied? Carfilzomib+Cyclophosphamide+Dexamethasone+Granulocyte Colony-Stimulating Factor
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
New Jersey
Hackensack Meridian Health - John Theurer Cancer Center
RECRUITING
Hackensack
Contact Information
Primary
Mariefel Vendivil
Mariefel.Vendivil@hmhn.org
551-996-5828
Backup
Geneva Khan
Geneva.Khan@hmhn.org
551-996-3923
Time Frame
Start Date: 2019-10-08
Estimated Completion Date: 2025-10
Participants
Target number of participants: 18
Treatments
Experimental: Carfilzomib Mobilization - Dose Level 0
Carfilzomib at 20mg/m2 over 10 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF.~For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing.
Experimental: Carfilzomib Mobilization - Dose Level 1
Carfilzomib at 27mg/m2 over 10 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF.~For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing.
Experimental: Carfilzomib Mobilization - Dose Level 2
Carfilzomib at 36mg/m2 over 30 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF.~For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing.
Experimental: Carfilzomib Mobilization - Dose Level 3
Carfilzomib at 45mg/m2 over 30 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF.~For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing.
Experimental: Carfilzomib Mobilization - Dose Level 4
Carfilzomib at 56mg/m2 over 30 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF.~For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing.
Experimental: Carfilzomib Mobilization - Dose Level 5
Carfilzomib at 70mg/m2 over 30 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF.~For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing.
Sponsors
Leads: Hackensack Meridian Health

This content was sourced from clinicaltrials.gov

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