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Continued Access to Ixazomib for Multiple Myeloma

Phase 2
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 up to 5 years
Awards & highlights

Study Summary

This trial is for people who have already participated in a study on ixazomib, and it will allow them to keep taking the drug.

Who is the study for?
This trial is for people who have lymphoma, multiple myeloma, or amyloidosis and were previously in an ixazomib study. They must agree to use birth control as before and join within 8 weeks of their last dose from the earlier study. Pregnant or breastfeeding women can't participate.Check my eligibility
What is being tested?
The trial provides ongoing access to ixazomib, a drug used in treating certain blood disorders like lymphoma and myeloma. It's for those who've already received it or other drugs in a prior Takeda-sponsored study.See study design
What are the potential side effects?
Ixazomib may cause gastrointestinal symptoms (like nausea and diarrhea), skin rash, fatigue, low platelet counts which can increase bleeding risk, nerve damage causing numbness or pain, and possible infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With New Primary Malignancies
Number of Participants With Serious Adverse Events (SAEs)
Number of Participants With any AE Resulting in Dose Modification or Discontinuation of any Study Drug
+3 more

Side effects data

From 2021 Phase 4 trial • 45 Patients • NCT03416374
67%
Rash
50%
Diarrhoea
50%
Decreased appetite
33%
Nasopharyngitis
33%
Taste disorder
33%
White blood cell count decreased
17%
Bone pain
17%
Compression fracture
17%
Constipation
17%
Malaise
17%
Tibia fracture
17%
Neutrophil count decreased
17%
Anaemia
17%
Pyrexia
17%
Platelet count decreased
17%
Spinal compression fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy
[Overall]; Combination Therapy + Ixazomib Therapy
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: IxazomibExperimental Treatment1 Intervention
Ixazomib capsule, orally, at same dose and schedule that participants were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experience an unacceptable toxicity, withdraw consent, pursue an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant is transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, whichever is sooner. Participants who were receiving a combination therapy with ixazomib and another medication(s) will continue to receive the combination regimen.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ixazomib
2017
Completed Phase 4
~3370

Find a Location

Who is running the clinical trial?

Millennium Pharmaceuticals, Inc.Lead Sponsor
404 Previous Clinical Trials
46,883 Total Patients Enrolled
82 Trials studying Multiple Myeloma
10,031 Patients Enrolled for Multiple Myeloma
TakedaLead Sponsor
1,208 Previous Clinical Trials
4,187,886 Total Patients Enrolled
50 Trials studying Multiple Myeloma
18,202 Patients Enrolled for Multiple Myeloma
Takeda Development Center Americas, Inc.Industry Sponsor
56 Previous Clinical Trials
12,003 Total Patients Enrolled

Media Library

Ixazomib Clinical Trial Eligibility Overview. Trial Name: NCT02924272 — Phase 2
Multiple Myeloma Research Study Groups: Ixazomib
Multiple Myeloma Clinical Trial 2023: Ixazomib Highlights & Side Effects. Trial Name: NCT02924272 — Phase 2
Ixazomib 2023 Treatment Timeline for Medical Study. Trial Name: NCT02924272 — Phase 2
~4 spots leftby Jun 2025
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