Actively Recruiting
Carfilzomib Based Chemotherapy Mobilization for Autologous Stem Cell Transplants in Multiple Myeloma
Led by Hackensack Meridian Health · Updated on 2026-02-18
18
Participants Needed
1
Research Sites
360 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Carfilzomib Based Chemotherapy Mobilization for Autologous Stem Cell Transplants in Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject has voluntarily agreed to participate by giving written informed consent before any study-related procedure.
- Confirmed diagnosis of multiple myeloma with measurable disease by specified criteria.
- Subject previously received treatment with carfilzomib.
- Subject is 18 years of age or older at the time of consent.
- ECOG performance status less than 2.
- Completed induction therapy and achieved less than a complete response.
- Life expectancy greater than 12 weeks.
- Absolute neutrophil count at least 1000 cells/mm3 (or 500 for high bone marrow involvement).
- Platelet count at least 50,000/mm3 (or 30,000 for high bone marrow involvement).
- Hemoglobin greater than 9.0 g/dL.
- Liver enzymes (AST and ALT) less than 3 times upper normal limit.
- Total bilirubin less than 1.5 times upper normal limit.
- MUGA scan or echocardiogram with left ventricular ejection fraction 40% or higher within 6 months.
- Females of childbearing potential with negative pregnancy tests as specified.
- Use of two highly effective contraception methods during and 90 days after treatment for sexually active females and males.
- Male subjects agree not to donate sperm while taking carfilzomib and for 90 days after last dose.
You will not qualify if you...
- History of allergic reactions to captisol or carfilzomib.
- NYHA Class III or IV heart disease or recent severe cardiac events within 6 months.
- Uncontrolled hypertension or pulmonary hypertension.
- Known HIV infection, active hepatitis C or B infections (with exceptions for treated cases under monitoring).
- Active viral or bacterial infections or other medical problems increasing treatment risk.
- Uncontrolled medical or psychiatric conditions including diabetes or liver disease.
- Peripheral neuropathy grade 2 or higher.
- Diagnosis or treatment of other cancers within 3 years except certain skin cancers and low-risk prostate cancer.
- Radiation therapy within 3 weeks before enrollment.
- Prior stem cell mobilization or transplant.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hackensack Meridian Health - John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
Research Team
M
Mariefel Vendivil
CONTACT
G
Geneva Khan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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