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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 randomization 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 107 months)
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 belowSelect...
I haven't had treatment after my stem cell transplant.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am 18 or older with a confirmed case of symptomatic multiple myeloma.
Select...
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:Select...
I do not have any uncontrolled heart problems.
Select...
I have an active hepatitis B or C infection, or I am HIV positive.
Select...
My multiple myeloma has come back or didn't respond to the first treatment.
Select...
I have not had radiotherapy in the last 14 days.
Select...
I have not had major surgery in the last 14 days.
Select...
I have been diagnosed with a specific blood disorder.
Select...
I am currently breastfeeding or pregnant.
Select...
My cancer has spread to my brain or spinal cord.
Select...
I haven't had cancer or been treated for another cancer in the last 5 years.
Select...
I am scheduled for or have had two sequential stem cell transplants.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ randomization 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 107 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization 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 107 months)
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
Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Domain Score
Correlation Between MRD Status and Overall Survival (OS)
+18 moreSide effects data
From 2023 Phase 3 trial • 656 Patients • NCT0218141339%
Nausea
34%
Diarrhoea
27%
Vomiting
27%
Arthralgia
25%
Upper respiratory tract infection
24%
Viral upper respiratory tract infection
23%
Nasopharyngitis
22%
Cough
20%
Pyrexia
20%
Back pain
20%
Fatigue
11%
Headache
10%
Peripheral sensory neuropathy
10%
Influenza
10%
Bronchitis
10%
Constipation
10%
Musculoskeletal pain
10%
Neuropathy peripheral
10%
Thrombocytopenia
9%
Oedema peripheral
9%
Herpes zoster
9%
Muscle spasms
9%
Bone pain
9%
Influenza like illness
9%
Pruritus
8%
Asthenia
8%
Pain in extremity
8%
Dizziness
8%
Insomnia
7%
Conjunctivitis
7%
Paraesthesia
7%
Oropharyngeal pain
7%
Productive cough
7%
Anaemia
6%
Rash maculo-papular
6%
Pneumonia
6%
Myalgia
6%
Rash macular
6%
Neutropenia
5%
Pharyngitis
5%
Sinusitis
5%
Musculoskeletal chest pain
5%
Hypertension
5%
Decreased appetite
3%
Dyspepsia
1%
Metapneumovirus infection
1%
Gastroenteritis
1%
Lower respiratory tract infection
1%
Myocardial ischaemia
1%
Cellulitis
1%
Osteonecrosis of jaw
1%
Basal cell carcinoma
1%
Plasma cell myeloma
1%
Pathological fracture
1%
Meniscus injury
1%
Pleural effusion
1%
Chronic obstructive pulmonary disease
100%
80%
60%
40%
20%
0%
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 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
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.
Find a Location
Who is running the clinical trial?
Millennium Pharmaceuticals, Inc.Lead Sponsor
405 Previous Clinical Trials
46,206 Total Patients Enrolled
82 Trials studying Multiple Myeloma
9,342 Patients Enrolled for Multiple Myeloma
TakedaLead Sponsor
1,238 Previous Clinical Trials
4,148,362 Total Patients Enrolled
50 Trials studying Multiple Myeloma
14,743 Patients Enrolled for Multiple Myeloma
Medical Director Clinical ScienceStudy DirectorMillennium Pharmaceuticals, Inc.
197 Previous Clinical Trials
62,509 Total Patients Enrolled
8 Trials studying Multiple Myeloma
1,968 Patients Enrolled for Multiple Myeloma
Study DirectorStudy DirectorTakeda
1,281 Previous Clinical Trials
499,846 Total Patients Enrolled
25 Trials studying Multiple Myeloma
4,040 Patients Enrolled for Multiple Myeloma