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Proteasome Inhibitor

Ixazomib 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of randomization to every 12 weeks until second pd or death (up to 88 months)

Awards & highlights

Study Summary

This trial will test whether ixazomib can help people with newly diagnosed myeloma who have had a good response to initial therapy and who have not undergone stem cell transplant.

Eligible Conditions

Multiple Myeloma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of randomization to every 12 weeks until second pd or death (up to 88 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of randomization to every 12 weeks until second pd or death (up to 88 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of randomization to every 12 weeks until second pd or death (up to 88 months) 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

Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status

Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) as Measured by the Global Health Status (GHS)

Correlation Between Frailty Status and PFS and OS

+16 more

Side effects data

From 2021 Phase 4 trial • 45 Patients • NCT03416374

26%

Diarrhoea

23%

White blood cell count decreased

21%

Platelet count decreased

15%

Neutrophil count decreased

13%

Pneumonia

Rash

Anaemia

Constipation

Malaise

Pyrexia

Acute kidney injury

Nasopharyngitis

Influenza

Pneumonia bacterial

Tumour lysis syndrome

Febrile neutropenia

Prinzmetal angina

Bile duct stone

Gastroenteritis

Interstitial lung disease

Taste disorder

Enterocolitis

Duodenal ulcer

100%

80%

60%

40%

20%

Study treatment Arm

[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy

[Overall]; Combination Therapy + Ixazomib Therapy

[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: IxazomibExperimental Treatment1 Intervention

Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.

Group II: PlaceboPlacebo Group1 Intervention

Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ixazomib

2017

Completed Phase 4

~3370

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Millennium Pharmaceuticals, Inc.Lead Sponsor

404 Previous Clinical Trials

46,208 Total Patients Enrolled

82 Trials studying Multiple Myeloma

9,356 Patients Enrolled for Multiple Myeloma

TakedaLead Sponsor

1,202 Previous Clinical Trials

4,177,556 Total Patients Enrolled

50 Trials studying Multiple Myeloma

17,527 Patients Enrolled for Multiple Myeloma

Study DirectorStudy DirectorTakeda

1,207 Previous Clinical Trials

488,974 Total Patients Enrolled

25 Trials studying Multiple Myeloma

6,824 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.

Has Ixazomib been green-lit by the FDA?

"Ixazomib's safety is estimated to be a 3. This assessment comes from the fact that this drug is in Phase 3 trials, indicating that there is some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

How many people are eligible to participate in this clinical trial?

"Unfortunately, this particular study is not recruiting patients right now. The listing was first posted on April 9th, 2015 and updated as recently as April 26th, 2022. However, there are 826 other clinical trials enrolling multiple myeloma patients and 70 Ixazomib studies that are still looking for participants."

Answered by AI

Are patients being recruited for this clinical trial at present?

"Unfortunately, this clinical trial is not enrolling patients at the moment. Although, it is important to note that this study was first posted on April 9th, 2015 and was updated as recently as April 26th, 2022. If you are seeking out other trials, 826 studies for multiple myeloma and 70 for Ixazomib are actively looking for participants."

Answered by AI

How many different hospitals are conducting this trial?

"To make participation more convenient for patients, this trial is enrolling at 30 sites located throughout the Greater Toronto Area. A few notable locations include Barrie, Brampton and Scarborough."

Answered by AI

What other research studies have included Ixazomib?

"At the moment, 70 different clinical trials are being conducted to study Ixazomib. Out of those, 8 have reached Phase 3. Even though most of the research is based in Cleveland, Ohio, there are 2381 medical facilities conducting these trials."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Ixazomib as Postinduction Maintenance for Patients with Newly Diagnosed Multiple Myeloma Not Undergoing Autologous Stem Cell Transplantation: The Phase III TOURMALINE-MM4 Trial

Dimopoulos, Meletios A., Ivan Špička, Hang Quach, Albert Oriol, Roman Hájek, Mamta Garg, Meral Beksac, et al.. 2020. “Ixazomib as Postinduction Maintenance for Patients with Newly Diagnosed Multiple Myeloma Not Undergoing Autologous Stem Cell Transplantation: The Phase III TOURMALINE-MM4 Trial”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.20.02060.

Journal of Clinical OncologyJournal

Ixazomib as Postinduction Maintenance for Patients with Newly Diagnosed Multiple Myeloma Not Undergoing Autologous Stem Cell Transplantation: The Phase III TOURMALINE-MM4 Trial

clinicaltrials.govStudy

A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT)

2015. "A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02312258.