Carfilzomib-Based Chemotherapy for Stem Cell Transplants in Multiple Myeloma
This study is looking at different doses of a drug called carfilzomib, combined with cyclophosphamide, dexamethasone, and G-CSF (Granulocyte Colony-Stimulating Factor, a drug that helps your body make more stem cells), to help collect stem cells for an autologous stem cell transplant (using your own stem cells) in people with multiple myeloma. The study aims to find the highest safe dose of carfilzomib and to see how many side effects participants experience over 24 months. You may be able to join if you have multiple myeloma and are at least 18 years old. The study is currently enrolling a small number of participants, about 18 people.
- Study design
- This is an open-label Phase I study, meaning both you and the study team will know which treatments you are receiving. It will involve a small number of participants, around 18, in groups that receive increasing doses of carfilzomib.
- What's involved
- You will receive carfilzomib, cyclophosphamide, and dexamethasone, followed by daily G-CSF injections. Stem cell collection will begin around day 12, and you will have monthly disease assessments after your transplant.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will have disease parameters assessed monthly after the transplant, and treatment-related adverse events will be assessed for 24 months.
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NCT03909412
Carfilzomib Based Chemotherapy Mobilization for Autologous Stem Cell Transplants in Multiple Myeloma
Recruiting
PHASE1Ages 18+InterventionalTreatmentHackensack Meridian HealthInvestigator-initiated
~18 participants
Updated 2026-02-18 on ClinicalTrials.gov
What's tested:CarfilzomibCyclophosphamideDexamethasoneGranulocyte Colony-Stimulating Factor
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured over 24 Months
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesNew Jersey1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
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 history of allergic reactions to compounds containing captisol, or Carfilzomib
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.
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 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.
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 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.
What this trial measures
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.024 Months
Safety and tolerability will be assessed by clinical review of all relevant parameters including Adverse Events (CTCAE v4.0)
- Maximum tolerated dose (MTD)28 Days
To determine the maximum tolerated dose (MTD) of carfilzomib in combination with cyclophosphamide, dexamethasone and G-CSF in mobilizing and collecting peripheral blood stem cells