Carfilzomib, Pomalidomide, and Dexamethasone in Treating Patients with High-Risk Multiple Myeloma
Multiple Myeloma
Plasma cell neoplasm
18 Years and older, Male and Female
Winship4101-17 (primary)
NCI-2017-02052
IRB00097882
Summary
This phase II trial studies how well carfilzomib, pomalidomide, and dexamethasone work in treating patients with high-risk multiple myeloma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as pomalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carfilzomib, pomalidomide, and dexamethasone may work better in treating patients with multiple myeloma.
Objectives
PRIMARY OBJECTIVE:
I. To determine the >= complete response (CR) rates with carfilzomib, pomalidomide and dexamethasone (CPd) maintenance.
SECONDARY OBJECTIVES:
I. To determine the improved progression free survival (PFS) with CPd maintenance among high-risk patients.
II. To determine the best response rates (very good partial response rate [VGPR], stringent complete response [sCR] rate) with CPd maintenance.
II. To evaluate the safety of the CPd combination as maintenance regimen.
III. To characterize safety in subjects who receive CPd maintenance.
IV. To evaluate the duration of response (DOR).
V. To evaluate the overall survival (OS) in high-risk patients.
VI. To evaluate the minimal residual disease (MRD) detection with CPd maintenance.
OUTLINE:
Patients receive carfilzomib intravenously (IV) over 30 minutes on days 1, 8, and 15, pomalidomide orally (PO) daily on days 1-21, and dexamethasone PO daily on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
Eligibility
- Patients must meet the following criteria on screening examination to be eligible to participate in the study; all laboratory assessments should be performed within 28 days of initiation of protocol therapy unless otherwise specified; subject is, in the investigator’s opinion, willing and able to comply with the protocol requirements
- Subject has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 1
- Subject is a transplant-eligible patient that have undergone autologous stem cell transplant (ASCT) within one year of their diagnosis and have achieved >= partial response (PR) based on International Myeloma Working Group (IMWG) standard criteria
- Patient’s with high risk disease defined as
* Presence of del(17p); t(4;14); t(14;16); t(14;20) by fluorescence in situ hybridization (FISH) or by cytogenetics (CTG)
* Plasma cell leukemia at diagnosis with >= 20% circulating plasma cells on peripheral blood
- Subject agrees to refrain from blood donations during therapy on study and for 90 days after therapy is completed
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 – 14 days prior to and again within 24 hours of starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide through 90 days after the last dose of study drug; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy from the time of signing the informed consent form through 90 days after the last dose of study drug; all patients must be registered in and must comply with all requirements of the pomalidomide Risk Evaluation and Mitigation Strategies (REMS) program; male subjects should refrain from sperm donation for at least 90 days after the last dose of carfilzomib or pomalidomide
* FCBP refers to sexually mature female, regardless of sexual orientation or whether they have undergone tubal ligation, who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally menopausal for at least 24 consecutive months
Treatment Sites in Georgia
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