What side effects are associated with this type of intervention?

Lenalidomide, commonly used in treating Multiple Myeloma, is associated with side effects such as neutropenia, which increases the risk of infections like pneumonia and urinary tract infections. Other common side effects include fatigue, gastrointestinal issues, and an increased risk of venous thromboembolism. Thalidomide and pomalidomide share similar side effects, with neutropenia being a notable concern. Bortezomib, another common treatment, often causes peripheral neuropathy, gastrointestinal distress, and cytopenias. These side effects can significantly impact the patient's quality of life and may require dose adjustments or additional supportive care.

What prior FDA approvals exist?

Lenalidomide, an immunomodulatory drug, has been approved by the FDA for the treatment of multiple myeloma, often in combination with dexamethasone. This combination has shown efficacy in both initial treatment and maintenance therapy. Other related drugs include thalidomide, which also modulates the immune system and inhibits angiogenesis, and pomalidomide, used in relapsed or refractory cases. Additionally, proteasome inhibitors like bortezomib and ixazomib have been approved for use in combination with lenalidomide and dexamethasone, enhancing the treatment's effectiveness by interfering with cancer cell growth.

What other types of research exist?

Promising alternatives to Lenalidomide for Multiple Myeloma patients include Pomalidomide and CC-4047 (also known as Actimid). Both are second-generation IMiDs with enhanced immunomodulatory and anticancer properties. Additionally, novel agents like Ixazomib citrate, a proteasome inhibitor, and monoclonal antibodies such as Daratumumab have shown efficacy in clinical trials and can be considered as part of combination therapies.

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Corticosteroid

Lenalidomide +/- Ixazomib + Dexamethasone for Multiple Myeloma

Phase 2

Waitlist Available

Led By Andrzej Jakubowiak

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

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

Must have

Patients who completed induction treatment followed by autologous stem cell transplant as initial therapy for symptomatic myeloma as per IMWG criteria and initiated Revlimid (lenalidomide) maintenance

Patients must have initiated lenalidomide maintenance at approximately 3 months post autologous stem transplant (preferably 70-90 but not more than 120 days)

Must not have

Diarrhea > grade 1 in the absence of anti-diarrheals

Uncontrolled diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 60 Other Conditions

No Placebo-Only Group

Summary

This trial compares the effectiveness of lenalidomide alone to a combination of lenalidomide, ixazomib citrate, and dexamethasone in patients with multiple myeloma that persists after a stem cell transplant. The drugs help the immune system fight cancer, stop cancer cells from growing, and kill them. Lenalidomide, a derivative of thalidomide, has been shown to be effective in combination with dexamethasone for treating multiple myeloma.

Who is the study for?

This trial is for multiple myeloma patients with residual disease after a donor stem cell transplant. They must have been on lenalidomide maintenance for 3-4 months, have measurable residual disease, and proper organ function. Women of childbearing potential and men must agree to effective contraception methods. Exclusions include uncontrolled conditions like heart issues or diabetes, recent infections or surgeries, other cancer treatments within 30 days, certain drug allergies, severe neuropathy, CNS involvement, and QTc >470 msec.

What is being tested?

The study compares the effectiveness of lenalidomide alone versus in combination with ixazomib citrate and dexamethasone in treating remaining multiple myeloma post-transplant. Lenalidomide may boost the immune system's ability to kill cancer cells; ixazomib could interfere with cancer cell growth; dexamethasone aims to stop cancer spread.

What are the potential side effects?

Potential side effects include immune system complications due to lenalidomide; gastrointestinal issues from ixazomib citrate affecting absorption or tolerance; blood sugar changes from dexamethasone use; fatigue; infection risk increase due to weakened immunity.

Eligibility Criteria

Inclusion Criteria

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

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I finished my first treatment for myeloma and started maintenance therapy with Revlimid.

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I started lenalidomide maintenance within 3 months after my stem cell transplant.

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My condition has not worsened while on lenalidomide.

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I am able to care for myself and perform daily activities.

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I am currently taking lenalidomide and can handle a higher dose.

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My kidney function, measured by creatinine clearance, is normal or near normal.

Exclusion Criteria

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

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I have mild to no diarrhea without taking medication.

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My diabetes is not under control.

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I haven't taken specific strong medications or herbal supplements in the last 14 days.

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I have a GI condition or had a procedure that affects my ability to take pills.

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I do not have uncontrolled heart conditions like severe heart failure or recent heart attacks.

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I have severe nerve damage in my hands or feet, or moderate with pain.

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I am not pregnant or breastfeeding.

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My cancer has worsened despite being on lenalidomide.

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I have not had major surgery in the last 2 weeks.

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I do not have an active infection, hepatitis B or C, or HIV.

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I have started or received a multi-drug treatment after my transplant, except for lenalidomide maintenance.

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My cancer has spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Rate of MRD between the two arms, as measured by flow cytometry and sequencing

Secondary study objectives

Duration of response (MRD-negative disease)

Estimated OS

Estimated PFS

+4 more

Other study objectives

Markers of response

Side effects data

From 2023 Phase 3 trial • 656 Patients • NCT02181413

39%

Nausea

35%

Diarrhoea

27%

Vomiting

25%

Upper respiratory tract infection

24%

Viral upper respiratory tract infection

22%

Arthralgia

22%

Cough

20%

Pyrexia

20%

Fatigue

19%

Back pain

11%

Headache

10%

Influenza

10%

Bronchitis

10%

Constipation

10%

Musculoskeletal pain

10%

Neuropathy peripheral

10%

Thrombocytopenia

Peripheral sensory neuropathy

Oedema peripheral

Herpes zoster

Muscle spasms

Bone pain

Influenza like illness

Asthenia

Pain in extremity

Dizziness

Insomnia

Conjunctivitis

Paraesthesia

Oropharyngeal pain

Productive cough

Anaemia

Pruritus

Rash maculo-papular

Pneumonia

Myalgia

Rash macular

Neutropenia

Pharyngitis

Sinusitis

Musculoskeletal chest pain

Hypertension

Decreased appetite

Dyspepsia

Metapneumovirus infection

Gastroenteritis

Lower respiratory tract infection

Myocardial ischaemia

Cellulitis

Osteonecrosis of jaw

Basal cell carcinoma

Plasma cell myeloma

Pathological fracture

Meniscus injury

Pleural effusion

Chronic obstructive pulmonary disease

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Ixazomib Citrate

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (ixazomib citrate, lenalidomide, dexamethasone)Experimental Treatment3 Interventions

Patients receive ixazomib citrate PO on days 1, 8, and 15, lenalidomide PO QD on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4 only).

Group II: Arm II (lenalidomide)Active Control1 Intervention

Patients receive lenalidomide PO as in Arm I.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

FDA approved

Ixazomib

FDA approved

Lenalidomide

FDA approved

0 / 18Eligibility 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

Lenalidomide enhances the immune system's ability to kill abnormal blood cells and inhibits angiogenesis, which is crucial for cancer growth. Ixazomib citrate interferes with proteins necessary for cancer cell growth, thereby stopping their proliferation. Dexamethasone, a corticosteroid, works by killing cancer cells, halting their division, and preventing their spread. These mechanisms are vital for Multiple Myeloma patients as they target the cancer cells through different pathways, potentially leading to more effective treatment outcomes and improved survival rates.

Lenalidomide enhances the protective effect of a therapeutic vaccine and reverses immune suppression in mice bearing established lymphomas.