What side effects are associated with this type of intervention?

Proteasome inhibitors, such as Ixazomib Citrate, bortezomib, and carfilzomib, are commonly used in the treatment of Multiple Myeloma. Known side effects of these treatments include gastrointestinal issues (nausea, vomiting, diarrhea), peripheral neuropathy, fatigue, and hematologic toxicities like thrombocytopenia and neutropenia. Additionally, patients may experience infections, hypertension, and cardiac events. Ixazomib Citrate specifically has been associated with increased rates of nausea, vomiting, and diarrhea, as well as higher incidences of grade 3 or greater treatment-emergent adverse events.

What prior FDA approvals exist?

Proteasome inhibitors have been a significant class of drugs approved by the FDA for the treatment of Multiple Myeloma. Bortezomib (Velcade) was one of the first proteasome inhibitors approved and has been widely used in various combinations for both initial treatment and relapsed cases. Carfilzomib (Kyprolis) is another proteasome inhibitor that has shown efficacy in relapsed or refractory multiple myeloma, often used in combination with other agents like dexamethasone. Ixazomib (Ninlaro) is an oral proteasome inhibitor that has been approved for use in combination with lenalidomide and dexamethasone for patients who have received at least one prior therapy. These drugs work by inhibiting the proteasome, which is essential for protein degradation in cells, thereby inducing apoptosis in myeloma cells.

What other types of research exist?

Promising alternatives to Ixazomib Citrate for Multiple Myeloma patients include: 1) Daratumumab in combination with bortezomib, melphalan, and prednisone (DVMP), which has shown superior PFS and overall survival (OS) in clinical trials. 2) Carfilzomib combined with dexamethasone and daratumumab (KdD), which has demonstrated efficacy and safety in relapsed or refractory multiple myeloma. 3) Pomalidomide, bortezomib, and low-dose dexamethasone, which have shown positive outcomes in the OPTIMISMM study for relapsed or refractory multiple myeloma.

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Proteasome Inhibitor

Ixazomib Citrate Maintenance Therapy for Multiple Myeloma

Phase 3

Waitlist Available

Research Sponsored by Millennium Pharmaceuticals, Inc.

Eligibility Criteria Checklist

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

Must have

Must have not received post-ASCT consolidation therapy

ECOG performance status of 0 to 2

Must not have

Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months

Active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to eot (24 months); thereafter followed up every 4 weeks until initiation of next-line therapy and then every 12 weeks until second progressive disease (pd2) or death (up to month 107)

Awards & highlights

Pivotal Trial

Summary

This trial is testing ixazomib citrate to see if it can help patients with newly diagnosed multiple myeloma who have responded to earlier treatments. The drug aims to slow down cancer progression by blocking proteins that cancer cells need to grow. Ixazomib has been used in various clinical settings for multiple myeloma, including relapsed and newly diagnosed cases.

Who is the study for?

Adults over 18 with symptomatic multiple myeloma who've had a positive response to stem cell transplant and meet specific health criteria. They must not have received certain treatments or have other serious conditions, agree to contraception if applicable, and be able to follow the study schedule.

What is being tested?

The trial is testing Ixazomib Citrate as a maintenance therapy against a placebo in patients with multiple myeloma post-autologous stem cell transplant. The goal is to see if it helps patients stay cancer-free for longer.

What are the potential side effects?

While the side effects of Ixazomib Citrate aren't detailed here, common ones may include gastrointestinal issues like nausea or diarrhea, low blood counts leading to increased infection risk, skin rash, fatigue, and potential liver problems.

Eligibility Criteria

Inclusion Criteria

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

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I haven't had treatment after my stem cell transplant.

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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 18 or older with a confirmed case of symptomatic multiple myeloma.

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My cancer responded well to a stem cell transplant.

Exclusion Criteria

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

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I do not have any uncontrolled heart problems.

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I have an active hepatitis B or C infection, or I am HIV positive.

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My multiple myeloma has come back or didn't respond to the first treatment.

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I have not had radiotherapy in the last 14 days.

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I have not had major surgery in the last 14 days.

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I have been diagnosed with a specific blood disorder.

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I am currently breastfeeding or pregnant.

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My cancer has spread to my brain or spinal cord.

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I haven't had cancer or been treated for another cancer in the last 5 years.

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I am scheduled for or have had two sequential stem cell transplants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to eot (24 months); thereafter followed up every 4 weeks until initiation of next-line therapy and then every 12 weeks until second progressive disease (pd2) or death (up to month 107)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to eot (24 months); thereafter followed up every 4 weeks until initiation of next-line therapy and then every 12 weeks until second progressive disease (pd2) or death (up to month 107)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to eot (24 months); thereafter followed up every 4 weeks until initiation of next-line therapy and then every 12 weeks until second progressive disease (pd2) or death (up to month 107) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression Free Survival (PFS)

Secondary study objectives

Correlation Between MRD Status and Progression Free Survival (PFS) and Overall Survival (OS)

Duration of the Next Line of Therapy

Eastern Cooperative Oncology Group (ECOG) Performance Score

+13 more

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Ixazomib CitrateExperimental Treatment1 Intervention

Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until progressive disease (PD), unacceptable toxicity, or discontinuation for alternate reasons. Participants who have had any dose reductions due to adverse events (AEs) would not be dose escalated.

Group II: PlaceboPlacebo Group1 Intervention

Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ixazomib Citrate

2012

Completed Phase 3

~970

0 / 14Eligibility 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

Proteasome inhibitors, such as Ixazomib Citrate, work by blocking the proteasome's function, which is essential for degrading unneeded or damaged proteins in cells. This inhibition leads to an accumulation of defective proteins, causing cancer cell death. Immunomodulatory drugs (IMiDs) like lenalidomide enhance the immune system's ability to attack myeloma cells and inhibit their growth. Monoclonal antibodies, such as daratumumab, target specific proteins on the surface of myeloma cells, marking them for destruction by the immune system. These mechanisms are crucial for Multiple Myeloma patients as they directly target and disrupt the survival and proliferation of cancer cells, leading to improved outcomes and prolonged progression-free survival.