← Back to Search

Proteasome Inhibitor

Open-Label Phase 1/2 Study of VELCADE for Injection in Patients With Light-chain (AL)-Amyloidosis

Phase 1 & 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 5 weeks in once weekly (qw) dose cohorts and 3 weeks in twice weekly (biw) dose cohorts
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved

Summary

This is a phase 1/2 open-label, dose-escalation study investigating single-agent therapy with VELCADE in patients with previously treated systemic AL-amyloidosis who require further treatment.

Eligible Conditions
  • Amyloidosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first study-related procedure to 30 days after last dose of study medication
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first study-related procedure to 30 days after last dose of study medication for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose
Subjects Grade 3/4/5 Treatment Emergent Adverse Events
Subjects With Serious Treatment Emergent Adverse Events
+2 more
Secondary study objectives
Best Confirmed Hematologic Responders

Side effects data

From 2009 Phase 1 & 2 trial • 70 Patients • NCT00298766
30%
Dizziness
27%
Pain in extremity
27%
Cough
24%
Paraesthesia
23%
Oedema peripheral
23%
Headache
21%
Oedema
19%
Back pain
17%
Anorexia
17%
Pyrexia
17%
Arthralgia
17%
Abdominal distension
16%
Muscle spasms
16%
Anaemia
16%
Nasopharyngitis
14%
Peripheral sensory neuropathy
13%
Oropharyngeal pain
13%
Pruritus
13%
Asthenia
11%
Dyspnoea exertional
11%
Dehydration
11%
Hypokalaemia
11%
Dry mouth
10%
Anxiety
10%
Neuropathy peripheral
10%
Chills
10%
Hypoaesthesia
9%
Conjunctivitis
9%
Dyspepsia
7%
Somnolence
7%
Dry skin
7%
Erythema
7%
Muscular weakness
7%
Palpitations
7%
Conjunctival haemorrhage
7%
Vision blurred
7%
Abdominal pain upper
7%
Influenza like illness
7%
Contusion
6%
Decreased appetite
6%
Pain
6%
Rhinorrhoea
6%
Periorbital haematoma
6%
Ecchymosis
6%
Hypertension
6%
Phlebitis
6%
Musculoskeletal pain
6%
Myalgia
6%
Dysphonia
6%
Night sweats
6%
Leukopenia
6%
Dry eye
6%
Abdominal discomfort
6%
Chest pain
6%
Early satiety
6%
Bronchitis
6%
Cystitis
6%
Urinary tract infection
4%
Pneumonia
3%
Hypotension
3%
Diarrhoea
3%
Vomiting
3%
Renal failure acute
1%
Orthostatic hypotension
1%
Atrial fibrillation
1%
Herpes zoster
1%
Ileus
1%
Escherichia bacteraemia
1%
Lobar pneumonia
1%
Respiratory tract infection
1%
Staphylococcal bacteraemia
1%
Cardiac failure acute
1%
Thrombocytopenia
1%
Cardiac failure cogestive
1%
Restrictive cardiomyopathy
1%
Abdominal pain
1%
Constipation
1%
Ileus paralytic
1%
Nausea
1%
Rectal haemorrhage
1%
Volvulus
1%
Fatigue
1%
Bacteraemia
1%
Upper respiratory tract infection
1%
Fall
1%
Hip fracture
1%
Fluid retention
1%
Autonomic neuropathy
1%
Cerebral ischaemia
1%
Loss of consciousness
1%
Neuralgia
1%
Insomnia
1%
Renal failure
1%
Penal impairment
1%
Dyspnoea
1%
Interstitial lung disease
1%
Pleural effusion
1%
Hyperhidrosis
1%
Rash
1%
Rash generalized
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Agent VELCADE

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
VELCADE
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bortezomib D-mannitol
FDA approved

Find a Location

Who is running the clinical trial?

Millennium Pharmaceuticals, Inc.Lead Sponsor
405 Previous Clinical Trials
46,792 Total Patients Enrolled
6 Trials studying Amyloidosis
318 Patients Enrolled for Amyloidosis
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry Sponsor
514 Previous Clinical Trials
844,589 Total Patients Enrolled
Medical MonitorStudy DirectorMillennium Pharmaceuticals, Inc.
1,678 Previous Clinical Trials
990,028 Total Patients Enrolled
2 Trials studying Amyloidosis
204 Patients Enrolled for Amyloidosis
~3 spots leftby Jan 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top