Combination treatment for relapsed or refractory multiple myeloma
Isa-CAPED MM: Isatuximab, Carfilzomib, Pomalidomide, and Dexamethasone (Isa-KPd) for Patients With Relapsed/Refractory Multiple Myeloma
This study is testing a combination of four medications to see if they can help people with relapsed or refractory multiple myeloma feel better and manage their disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 37 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Drugs / interventions | isatuximab |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT04883242 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the effects of a combination of isatuximab, carfilzomib, pomalidomide, and dexamethasone in patients with relapsed or refractory multiple myeloma. The treatment involves an induction phase followed by a maintenance phase, where patients receive these medications over a series of cycles. The study includes various assessments such as bone marrow biopsies and imaging to monitor disease progression and treatment response. Patients will be followed for up to five years after treatment completion to evaluate long-term outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory multiple myeloma who have received at least one prior therapy.
Not a fit: Patients who have not received prior lenalidomide therapy or have severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for patients with difficult-to-treat multiple myeloma.
How similar studies have performed: Other studies have shown promising results with similar combinations of therapies in treating multiple myeloma, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where this trial is running
Seattle, Washington
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Andrew J. Cowan — Fred Hutch/University of Washington Cancer Consortium
- Study coordinator: Andrew J. Cowan
- Email: ajcowan@fredhutch.org
- Phone: 206.667.4551
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.