Status:
ACTIVE_NOT_RECRUITING
Isatuximab, Carfilzomib, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Recurrent Multiple Myeloma
Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies the effect of isatuximab, carfilzomib, pomalidomide, and dexamethasone in treating patients with multiple myeloma that has come back (relapsed) or does not respond to treat...
Detailed Description
OUTLINE: INDUCTION: Patients receive isatuximab intravenously (IV) on days 1, 8, 15, and 22 of cycle 1 and days 1 and 15 of subsequent cycles carfilzomib IV over 30 minutes on days 1, 8, and 15, poma...
Eligibility Criteria
Inclusion
- Patients with relapsed or refractory multiple myeloma, with \>= 1 prior therapy
- Must have received prior lenalidomide therapy
- Must have measurable disease, as defined by International Myeloma Working Group criteria, having one or more of the following:
- Serum M protein \>= 0.5 g/dL
- Urine M protein \>= 200 mg/24 hours
- Involved serum free light chain level \>= 10 mg/dL with abnormal kappa/lambda ratio
- Measurable biopsy-proven plasmacytomas (\>= 1 lesion has a single diameter \>= 2 cm)
- Bone marrow plasma cells \>= 30%
- Age 18 years and older, and have the capacity to give informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Subjects should have resolution of any toxicities from prior therapy to grade =\< 1 or baseline prior to enrollment (with the exception of peripheral neuropathy)
- Subjects are required to have grade =\< 2 peripheral neuropathy to enroll
- Prior autologous stem cell transplant is allowed; patients must be \>= 6 months post- autologous stem cell transplantation to enroll
- Estimated glomerular filtration rate (eGFR) \>= 20 ml/min
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x upper limit of normal (ULN)
- Total bilirubin =\< 2 x ULN
- Absolute neutrophil count (ANC) \>= 1,000/uL
- Platelets \>= 50,000/uL
- Hemoglobin \>= 8 g/dL
- Growth factor use or transfusions may be used to meet the eligibility requirement for ANC, platelets, and hemoglobin
- Female patients of childbearing potential and male patients must agree to use 2 effective forms of contraception or continuously abstain from heterosexual intercourse during the period of therapy, and for 6 months after discontinuation of study treatment for females and 3 months after discontinuation of study treatment for males
Exclusion
- History of clinically significant cardiovascular disease, including congestive heart failure New York Heart Association (NYHA) class 3-4, symptomatic ischemia, left ventricular ejection fraction \< 40%, uncontrolled conduction abnormalities, myocardial infarction in last 6 months
- Uncontrolled hypertension as determined by the principal investigator (PI) or designee
- Active plasma cell leukemia or systemic amyloid light-chain (AL) amyloidosis
- History of another primary malignancy that has not been in remission for at least 1 year
- However, the following diagnoses are eligible for inclusion: non-melanoma skin cancer, localized prostate cancer, superficial bladder cancer, cervical carcinoma in situ, on biopsy or any prior malignancy with an estimated \> 90% 1-year cure rate per sponsor-investigator
- For patients with chronic hepatitis B viral infection, the hepatitis B virus (HBV) polymerase chain reaction (PCR) must be undetectable on suppressive therapy
- Patients with a history of Hepatitis C viral infection must have been treated and cured. For patients on treatment for hepatitis C, they are eligible if they have an undetectable hepatitis C virus (HCV) viral load
- Subjects with active uncontrolled infection
- Concurrent use of other anticancer agents or experimental treatments
Key Trial Info
Start Date :
July 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2031
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04883242
Start Date
July 29 2021
End Date
December 31 2031
Last Update
September 26 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109