What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, such as bortezomib, lenalidomide, dexamethasone, cyclophosphamide, daratumumab, and ixazomib, are associated with a range of side effects. These include gastrointestinal issues (nausea, vomiting, diarrhea, constipation), hematologic toxicities (thrombocytopenia, anemia), infections, fatigue, peripheral neuropathy, and cardiovascular events (hypertension, cardiac toxicity). Additionally, treatments like lenalidomide and pomalidomide have been linked to a higher risk of venous thromboembolism (VTE). Patients often require dose adjustments or discontinuation due to these adverse effects.

What prior FDA approvals exist?

Several drugs have received FDA approval for the treatment of relapsed or refractory multiple myeloma. These include bortezomib, lenalidomide, and dexamethasone, which are often used in combination regimens. Other notable approvals include carfilzomib, pomalidomide, and the monoclonal antibodies daratumumab and isatuximab. Additionally, selinexor has been approved for use in patients with multiple myeloma who have received at least one prior therapy. These treatments have been evaluated in various phase 2 and phase 3 clinical trials, demonstrating efficacy in managing relapsed or refractory multiple myeloma.

What other types of research exist?

Promising novel alternatives to ION251 for Multiple Myeloma patients include ixazomib plus dexamethasone, which has shown efficacy in relapsed or refractory cases. Additionally, proteasome inhibitors like bortezomib and lenalidomide-based regimens are frequently used and have demonstrated effectiveness. These treatments provide durable responses and are supported by clinical trial data.

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CAR T-cell Therapy

ION251 for Multiple Myeloma

Phase 1

Waitlist Available

Research Sponsored by Ionis Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 days from the last dose of study drug in cycle 1 (each cycle is 28 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing ION251, a new drug, in patients with multiple myeloma. The goal is to determine the appropriate dosage by starting with small amounts and increasing them over time.

Who is the study for?

This trial is for adults over 18 with relapsed/refractory multiple myeloma who have not responded to, cannot tolerate, or are ineligible for established therapies. Participants must have measurable MM and be in good physical condition (ECOG status of 0 or 1). They can't join if they have low blood counts, uncontrolled high blood pressure, certain other cancers or bleeding disorders, poor kidney function, or significantly elevated liver enzymes.

What is being tested?

The study aims to find the safest and most effective dose of a new drug called ION251 for patients with multiple myeloma that has come back after treatment or hasn't responded to previous treatments. The focus is on determining the maximum-tolerated dose and the recommended Phase 2 dose.

What are the potential side effects?

While specific side effects of ION251 are not listed here, common side effects in trials like this may include nausea, fatigue, lowered immunity leading to infections, anemia causing tiredness and weakness; as well as potential impacts on liver function which could cause jaundice.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28 days from the last dose of study drug in cycle 1 (each cycle is 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 28 days from the last dose of study drug in cycle 1 (each cycle is 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days from the last dose of study drug in cycle 1 (each cycle is 28 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum-Tolerated Dose (MTD)

Recommended Phase 2 Dose (PR2D)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ION251Experimental Treatment1 Intervention

In Part 1, the dose escalation phase, increased amounts of ION251 will be administered at multiple time points by intravenous (IV) infusion during 28-day cycles. In Part 2, the determined RP2D of ION251 will be administered at multiple time points by IV infusion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ION251

2021

Completed Phase 1

~30

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Multiple Myeloma include proteasome inhibitors, immunomodulatory drugs, and monoclonal antibodies. Proteasome inhibitors like bortezomib and carfilzomib work by blocking the proteasome, a complex that degrades unneeded proteins, leading to the accumulation of toxic proteins in cancer cells and inducing cell death. Immunomodulatory drugs such as lenalidomide and pomalidomide enhance the immune system's ability to attack cancer cells and inhibit their growth. Monoclonal antibodies like daratumumab and isatuximab target specific proteins on the surface of myeloma cells, marking them for destruction by the immune system. These treatments are crucial for Multiple Myeloma patients as they target the cancer cells through different mechanisms, improving treatment efficacy and patient outcomes.

How I treat high-risk myeloma.Monoclonal antibodies for the treatment of cancer.