New Four-Drug cocktail aims to tackle tough myeloma
NCT ID NCT04883242
First seen Jun 24, 2026 · Last updated Sep 17, 2026 · Updated 3 times
Summary
This phase 2 trial tests a combination of four drugs—isatuximab, carfilzomib, pomalidomide, and dexamethasone—in 30 patients with multiple myeloma that has relapsed or become resistant to treatment. The goal is to see how many patients respond to this regimen. All participants have had at least one prior therapy and have received lenalidomide before.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- isatuximab, carfilzomib, pomalidomide, and dexamethasone
- What this could lead to
- If successful, this combination could offer a new treatment option for patients whose multiple myeloma has returned or stopped responding to prior therapies.
- What could go wrong
- This is a small, early-phase (phase 2) trial with only 30 participants, so results may not apply to all patients. The drug combination can cause side effects like low blood counts, infections, and heart or lung issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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30 people
The number who actually took part.
- Started
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Jul 2021
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a One-Two drug punch beat back Hard-to-Treat myeloma?
- CAR-T breakthroughs come with infection risks – new study aims to decode them
- Double-barreled CAR t therapy takes aim at hard-to-treat myeloma
- Can a drug stop dangerous side effects of new myeloma therapies?