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New treatment option for Multiple Myeloma
Official title Carfilzomib Based Chemotherapy Mobilization for Autologous Stem Cell Transplants in Multiple Myeloma
ClinicalTrials.gov ID: NCT03909412
What this study is testing
What is Carfilzomib?
Carfilzomib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for multiple myeloma.
Also referred to as Kyprolis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject has voluntarily agreed to participate by giving written informed consent before performance of any study-related procedure not part of normal...
- Subject has a confirmed diagnosis of multiple myeloma as specified by the International Myeloma Working Group criteria and must have measurable...
- 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
You likely can't join if
- 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...
- Uncontrolled hypertension.
- Pulmonary hypertension.
- Known HIV infection, hepatitis C infection (people with hepatitis C that achieve a sustained virologic response after antiviral therapy are allowed)...
- Subject has active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment...
See the full eligibility 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...
- 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.
- people 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...
- FCBP and male people 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...
- Male people must agree to not donate sperm while taking carfilzomib and for 90 days after the last dose of carfilzomib.
- 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...
- Uncontrolled hypertension.
- Pulmonary hypertension.
- Known HIV infection, hepatitis C infection (people with hepatitis C that achieve a sustained virologic response after antiviral therapy are allowed), or hepatitis B infection (people with hepatitis B surface antigen or...
- 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...
- 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...
- Subject has received radiation therapy within 3 weeks of enrollment. Enrollment of people who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is...
- Subject has had prior mobilization or stem cell transplant.
The study team makes the final eligibility decision.
Where it's taking place
- Hackensack, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hackensack, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.