What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, such as Ruxolitinib (JAK inhibitor), Steroids, and Lenalidomide, have various side effects. Ruxolitinib can cause anemia, thrombocytopenia, and increased risk of infections. Steroids are associated with side effects like hyperglycemia, hypertension, mood swings, and increased risk of infections. Lenalidomide's side effects include fatigue, diarrhea, constipation, rash, and a higher risk of blood clots. These treatments can also lead to more severe toxicities such as pneumonia, lower respiratory tract infections, and urinary tract infections.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Multiple Myeloma, including lenalidomide, which is an immunomodulatory agent with anti-angiogenic and anti-proliferative properties. Lenalidomide is often used in combination with dexamethasone, a steroid with anti-inflammatory and cytotoxic effects, for both initial treatment and relapsed/refractory cases. Additionally, bortezomib, a proteasome inhibitor, has been approved for use in patients with progressive Multiple Myeloma after one prior therapy. While Ruxolitinib, a JAK inhibitor, is not specifically mentioned in the context of Multiple Myeloma, the combination of immunomodulatory drugs, steroids, and other agents like proteasome inhibitors forms the backbone of current treatment regimens.

What other types of research exist?

Promising novel alternatives for Multiple Myeloma treatment include: 1) Belantamab mafodotin, an antibody-drug conjugate targeting BCMA, 2) Teclistamab, a bispecific antibody targeting BCMA and CD3, 3) Selinexor, a selective inhibitor of nuclear export, 4) Venetoclax, a BCL2 inhibitor, particularly in combination with other agents, and 5) Carfilzomib, a proteasome inhibitor, often used in combination regimens. These treatments have shown efficacy in clinical trials and represent innovative approaches for managing Multiple Myeloma.

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Immunomodulatory Agent

Ruxolitinib + Steroids + Lenalidomide for Multiple Myeloma

Phase 1

Recruiting

Led By James R Berenson, MD

Research Sponsored by Oncotherapeutics

Eligibility Criteria Checklist

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

Must have

Previous exposure to lenalidomide independent of the response

Able to take aspirin (acetylsalicylic acid, ASA) at 81 or 325 mg/daily as antiplatelet therapy if platelet count is above 30 x 10E9/L

Must not have

The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs

Primary amyloidosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 54 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of ruxolitinib, steroids, and lenalidomide in multiple myeloma patients who are not responding to current treatments. The drugs work together to block cancer growth signals, reduce inflammation, and enhance the immune response. Lenalidomide is an immunomodulatory drug developed from thalidomide, effective in multiple myeloma and approved by the FDA.

Who is the study for?

This trial is for Multiple Myeloma patients who've had the disease progress despite previous treatments and can't have a transplant. They should be able to perform daily activities with ease (ECOG ≤ 2), not be pregnant, sign consent forms, follow the study schedule, live more than 3 months, join REVLIMID REMS™ program, take aspirin if safe, and have measurable MM with certain lab results.

What is being tested?

The study tests the combination of Ruxolitinib (Jakafi), steroids (Methylprednisolone), and Lenalidomide in those whose Multiple Myeloma has worsened. It's an early-stage trial to check how safe this mix is and how well it works against MM when other treatments haven't helped.

What are the potential side effects?

Possible side effects include immune system suppression leading to infections, blood clots due to lenalidomide which requires aspirin use if platelets are sufficient; potential risks from steroids like increased blood sugar or bone weakening; and Jakafi might cause dizziness or headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been treated with lenalidomide before.

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I can take aspirin daily and my platelet count is above 30 x 10E9/L.

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I have multiple myeloma with signs that can be measured.

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My multiple myeloma is getting worse.

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I have been diagnosed with multiple myeloma.

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I can take care of myself and am up and about more than half of my waking hours.

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I am not eligible for a transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I developed a peeling rash from taking thalidomide or similar medication.

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I have been diagnosed with primary amyloidosis.

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I have not had major surgery in the last 28 days or still have side effects from it.

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I have heart problems that affect my daily activities.

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I have been diagnosed with POEMS syndrome.

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I am allergic to thalidomide, lenalidomide, or steroids.

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I have a high number of plasma cells in my blood.

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I am not using any other cancer treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 54 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~54 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 54 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Determination of maximum tolerated dose (MTD) of ruxolitinib in combination with steroids and lenalidomide [Tolerability].

Incidence of Treatment-Emergent Adverse Events [Safety]

Secondary study objectives

Assessment of response in additional cohorts

Assessment of the duration of response as a measure of efficacy (DOR)

Assessment of the overall survival (OS) as a measure of efficacy

+5 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Rux and Steroid until progression, then add LenExperimental Treatment3 Interventions

Subject will receive Ruxolitinib Oral Tablet \[Jakafi\] at 15mg BID, and Methylprednisolone at 40mg QOD until disease progression. Lenalidomide at 10mg QD will be added to the treatment (Ruxolitinib, Methylprednisolone) once disease progression was confirmed.

Group II: Rux Len and SteroidExperimental Treatment3 Interventions

Ruxolitinib Oral Tablet \[Jakafi\] at 5mg, 10mg or 15mg BID, Lenalidomide Oral at 5mg or 10mg QD and Methylprednisolone Oral at 40mg QOD. (Dose varies during dose escalation portion of the study)

Group III: High-dose RuxolitinibExperimental Treatment2 Interventions

Subject will receive Ruxolitinib Oral Tablet \[Jakafi\] at 20mg BID and Methylprednisolone at 40mg QOD until disease progression.

Group IV: Expanded Eligibility CriteriaExperimental Treatment3 Interventions

Subject will receive Ruxolitinib Oral Tablet \[Jakafi\] at 15mg BID, Lenalidomide at 10mg QD, and Methylprednisolone at 40mg QOD until disease progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

2005

Completed Phase 3

~2240

Methylprednisolone

2015

Completed Phase 4

~2280

0 / 15Eligibility criteria met

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

Ruxolitinib is a JAK inhibitor that interferes with the JAK-STAT signaling pathway, which is often overactive in cancer cells, thereby reducing cell proliferation and survival. Steroids, such as dexamethasone, have anti-inflammatory and cytotoxic effects that help reduce tumor burden and manage symptoms. Lenalidomide is an immunomodulatory drug that enhances the immune system's ability to attack cancer cells, inhibits angiogenesis (formation of new blood vessels that supply the tumor), and directly induces cancer cell death. These mechanisms are crucial for Multiple Myeloma patients as they target different aspects of the disease, helping to control tumor growth, improve symptoms, and potentially prolong survival.