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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

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

Study Summary

This trial will compare the effect of ixazomib citrate maintenance therapy versus placebo on progression-free survival in participants with newly diagnosed multiple myeloma who have responded to induction therapy, high-dose therapy, and autologous stem cell transplant.

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.Check my eligibility

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.See study design

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.

Select...

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

Select...

My cancer responded well to a stem cell transplant.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS)

Secondary outcome measures

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

+16 more

Side effects data

From 2021 Phase 2 trial • 8 Patients • NCT03202628

100%

Fatigue

100%

Neutrophil count decreased

100%

White blood cell decreased

88%

Platelet count decreased

75%

Diarrhea

75%

Lymphocyte count decreased

63%

Constipation

63%

Peripheral sensory neuropathy

50%

Nausea

50%

Creatinine increased

25%

Hyperglycemia

13%

Urinary tract infection

13%

Wrist fracture

13%

Cardiac disorders - Other, specify

13%

Vomiting

13%

Anorexia

13%

Insomnia

13%

Hypoxia

13%

Resp, thoracic, mediastinal - Oth spec

13%

Hypoglycemia

13%

Tremor

13%

Anemia

13%

Blood and lymph sys disorders - Oth Spec

13%

Febrile neutropenia

13%

Fever

13%

Alkaline phosphatase increased

13%

Pneumonitis

13%

Rash maculo-papular

13%

Thromboembolic event

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Ixazomib, Pomalidomide, Dexamethasone, ASCT)

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 2

~200

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Millennium Pharmaceuticals, Inc.Lead Sponsor

404 Previous Clinical Trials

46,258 Total Patients Enrolled

82 Trials studying Multiple Myeloma

9,406 Patients Enrolled for Multiple Myeloma

TakedaLead Sponsor

1,202 Previous Clinical Trials

4,177,606 Total Patients Enrolled

50 Trials studying Multiple Myeloma

17,577 Patients Enrolled for Multiple Myeloma

Study DirectorStudy DirectorTakeda

1,207 Previous Clinical Trials

489,024 Total Patients Enrolled

25 Trials studying Multiple Myeloma

6,874 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any long-term effects of taking Ixazomib Citrate?

"Ixazomib Citrate is in Phase 3 of clinical trials, so there is data supporting both its efficacy and safety. Our team Power gave it a score of 3."

Answered by AI

Is this the first time Ixazomib Citrate has been studied?

"There are currently 69 active trials for Ixazomib Citrate. This includes 8 trials that are in Phase 3. A total of 2348 locations are running these trials. The majority of these trials for Ixazomib Citrate are located in Cleveland, Ohio."

Answered by AI

Recent research and studies

Annals of HematologyJournal

Adverse Event Management in the TOURMALINE-MM3 Study of Post-transplant Ixazomib Maintenance in Multiple Myeloma

Kaiser, Martin, Meral Beksaç, Nina Gulbrandsen, Fredrik Schjesvold, Roman Hájek, Philippe Moreau, Felipe de Arriba de la Fuente, et al.. 2020. “Adverse Event Management in the TOURMALINE-MM3 Study of Post-transplant Ixazomib Maintenance in Multiple Myeloma”. Annals of Hematology. Springer Science and Business Media LLC. doi:10.1007/s00277-020-04149-5.

The LancetJournal

Oral Ixazomib Maintenance Following Autologous Stem Cell Transplantation (TOURMALINE-MM3): A Double-blind, Randomised, Placebo-controlled Phase 3 Trial

Dimopoulos, Meletios A, Francesca Gay, Fredrik Schjesvold, Meral Beksac, Roman Hajek, Katja Christina Weisel, Hartmut Goldschmidt, et al.. 2019. “Oral Ixazomib Maintenance Following Autologous Stem Cell Transplantation (TOURMALINE-MM3): A Double-blind, Randomised, Placebo-controlled Phase 3 Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(18)33003-4.

European Journal of HaematologyJournal

Quality of Life Is Maintained with Ixazomib Maintenance in Post‐transplant Newly Diagnosed Multiple Myeloma: The TOURMALINE‐MM3 Trial

Schjesvold, Fredrik, Hartmut Goldschmidt, Vladimir Maisnar, Ivan Spicka, Neils Abildgaard, Philip Rowlings, Lauren Cain, et al.. 2020. “Quality of Life Is Maintained with Ixazomib Maintenance in Post‐transplant Newly Diagnosed Multiple Myeloma: The TOURMALINE‐MM3 Trial”. European Journal of Haematology. Wiley. doi:10.1111/ejh.13379.

The LancetJournal