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New Four-Drug cocktail aims to tackle tough myeloma

NCT ID NCT04883242

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

30 people

The number who actually took part.

Started

Jul 2021

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • 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.