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Corticosteroid

IXAZOMIB for Light Chain Amyloidosis

Phase 3
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female participants 18 years or older.
Histochemical diagnosis of amyloidosis, as based on tissue specimens with Congo red staining with exhibition of an apple-green birefringence
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is studying whether ixazomib plus dexamethasone is better than other chemotherapy regimens at treating AL amyloidosis.

Eligible Conditions
  • Light Chain Amyloidosis

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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
2-Year Vital Organ (Heart or Kidney) Deterioration and Mortality Rate
Percentage of Participants With Overall Hematologic Response
Secondary outcome measures
Change From Baseline in 36-item Short Form General Health Survey (SF-36) Mental Component Summary Score at Week 28 of the PFS Follow-up
Change From Baseline in Amyloidosis Symptom Scale Total Score at Week 28 of the PFS Follow-up
Change From Baseline in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) Score at Week 28 of the PFS Follow-up
+16 more

Side effects data

From 2017 Phase 2 trial • 29 Patients • NCT01939899
42%
Diarrhoea
42%
Vomiting
42%
Nausea
33%
Asthenia
33%
Pyrexia
25%
Abdominal pain
25%
Thrombocytopenia
17%
Fatigue
17%
Headache
17%
Neutropenia
17%
Urinary tract infection
17%
Neutrophil count decreased
17%
Myalgia
17%
Decreased appetite
8%
Abdominal pain upper
8%
Local swelling
8%
Dysgeusia
8%
Musculoskeletal chest pain
8%
Non-Hodgkin's lymphoma
8%
Tumour pain
8%
Constipation
8%
Chills
8%
Dizziness
8%
Hypokalaemia
8%
Dermatitis acneiform
8%
Dry skin
8%
Nasopharyngitis
8%
Cough
8%
Dyspnoea
8%
Epistaxis
8%
Arthralgia
8%
Hypotension
8%
Back pain
8%
Neuropathy peripheral
8%
Night sweats
8%
Fall
8%
Pain in extremity
8%
Herpes zoster
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2: PSMB1 Positive
Phase 2: PSMB1 Negative
Lead-in Dose Finding Phase: Ixazomib 4 mg
Lead-in Dose Finding Phase: Ixazomib 5.3 mg
Lead-in Dose Finding Phase: Ixazomib 7.0 mg

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: Ixazomib + DexamethasoneExperimental Treatment2 Interventions
Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated.
Group II: Arm B: Dexamethasone + MelphalanActive Control2 Interventions
Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months.
Group III: Arm B: Dexamethasone + LenalidomideActive Control2 Interventions
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15 and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months.
Group IV: Arm B: Dexamethasone + ThalidomideActive Control2 Interventions
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15 and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months.
Group V: Arm B: Dexamethasone + CyclophosphamideActive Control2 Interventions
Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8 and 15 of each 28-day cycle for up to a maximum of 72.4 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IXAZOMIB
2009
Completed Phase 2
~240
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,198 Previous Clinical Trials
4,178,176 Total Patients Enrolled
Millennium Pharmaceuticals, Inc.Lead Sponsor
404 Previous Clinical Trials
46,772 Total Patients Enrolled
Medical DirectorStudy DirectorTakeda
2,769 Previous Clinical Trials
8,062,023 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~14 spots leftby Mar 2025