ACTIVE_NOT_RECRUITING

Isatuximab, Carfilzomib, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma

Conditions

Recurrent Multiple Myeloma Refractory Multiple Myeloma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 treatment (refractory). Isatuximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Carfilzomib may stop the growth of cancer cells by blocking some of the proteins needed for cell growth. Pomalidomide may help shrink or slow the growth of multiple myeloma. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving isatuximab, carfilzomib, pomalidomide, and dexamethasone may kill more cancer cells.

Official Title

Isa-CAPED MM: Isatuximab, Carfilzomib, Pomalidomide, and Dexamethasone (Isa-KPd) for Patients With Relapsed/Refractory Multiple Myeloma

Quick Facts

Study Start:2021-07-29

Study Completion:2031-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04883242

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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

Inclusion Criteria

Exclusion Criteria

* 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

* 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

Contacts and Locations

Principal Investigator

Rahul Banerjee, MD

PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Study Locations (Sites)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109

United States

Collaborators and Investigators

Sponsor: University of Washington

Rahul Banerjee, MD, PRINCIPAL_INVESTIGATOR, Fred Hutch/University of Washington Cancer Consortium

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-29

Study Completion Date2031-12-31

Study Record Updates

Study Start Date2021-07-29

Study Completion Date2031-12-31

Terms related to this study

Additional Relevant MeSH Terms

Recurrent Multiple Myeloma
Refractory Multiple Myeloma