Venetoclax for Amyloidosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Amyloidosis+5 More
Venetoclax - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a combination of drugs to treat light chain amyloidosis that has come back or does not respond to treatment. The drugs are venetoclax, ixazomib citrate, and dexamethasone.

Eligible Conditions
  • Amyloidosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Amyloidosis

Study Objectives

3 Primary · 1 Secondary · Reporting Duration: Up to 2.5 years

Year 5
Overall response rate (complete hematologic response)
Baseline
Expression of BCL-2, BCL-XL, BAX, BAK, BIM, NOXA, and MCL-1
Before and during treatment
Immune profile in the peripheral blood
Up to 2.5 years
Characterization of CD138+ plasma cell with t(11;14)
Hematologic response rates
Presence of minimal residual disease
Up to 30 days
Incidence of adverse events
Up to the end of cycle 1
Maximum tolerated dose
Recommended phase 2 dose (RP2D)

Trial Safety

Safety Progress

1 of 3

Other trials for Amyloidosis

Side Effects for

Venetoclax + Rituximab
61%Neutropenia
39%Diarrhoea
21%Nausea
21%Upper respiratory tract infection
18%Fatigue
18%Cough
14%Constipation
14%Anaemia
14%Pyrexia
12%Thrombocytopenia
11%Headache
11%Nasopharyngitis
11%Insomnia
10%Bronchitis
9%Sinusitis
8%Vomiting
8%Infusion related reaction
8%Back pain
8%Pneumonia
7%Rash
7%Pharyngitis
7%Abdominal pain
6%Dizziness
6%Hypokalaemia
6%Hyperkalaemia
6%Hypertension
6%Productive cough
6%Lower respiratory tract infection
6%Neutrophil count decreased
6%Oedema peripheral
6%Urinary tract infection
6%Dyspnoea
6%Arthralgia
5%Alanine aminotransferase increased
5%Conjunctivitis
5%Oropharyngeal pain
5%Pruritus
4%Chills
4%Febrile neutropenia
4%Oral herpes
4%Decreased appetite
2%Influenza
2%Tumour lysis syndrome
2%Muscle spasms
2%Autoimmune haemolytic anaemia
2%Lung infection
2%Squamous cell carcinoma
1%Respiratory tract infection
1%Sepsis
1%Skin cancer
1%Oesophageal obstruction
1%Dyspepsia
1%Gastrointestinal haemorrhage
1%Deafness
1%Urinary tract infection pseudomonal
1%Myocardial infarction
1%Hyperpyrexia
1%Immune thrombocytopenic purpura
1%Cardiac failure
1%Colorectal cancer
1%Moraxella infection
1%Diabetes mellitus
1%Pneumonia streptococcal
1%Deep vein thrombosis
1%Erysipelas
1%Vertigo
1%Eye haemorrhage
1%Pneumonia influenzal
1%Lacunar infarction
1%Myelodysplastic syndrome
1%Ascites
1%Disseminated intravascular coagulation
1%Diverticulitis
1%Tooth abscess
1%Herpes simplex otitis externa
1%Small intestinal obstruction
1%Sudden cardiac death
1%Haemophilus infection
1%Meningitis
1%Peritoneal tuberculosis
1%Dehydration
1%Pancytopenia
1%Angina pectoris
1%Herpes zoster
1%Status epilepticus
1%Ventricular tachycardia
1%Rhinovirus infection
1%Viral upper respiratory tract infection
1%Adenocarcinoma gastric
1%Campylobacter gastroenteritis
1%Cystitis
1%Gastroenteritis rotavirus
1%Viral infection
1%Humerus fracture
1%Respiratory tract infection fungal
1%Colon cancer
1%Cervical dysplasia
1%Hyperphosphataemia
1%Malignant melanoma
1%Nephrolithiasis
1%Uterine haemorrhage
1%Metastatic malignant melanoma
1%Pancreatic carcinoma
1%Prostatic adenoma
1%Acute kidney injury
1%Bronchiectasis
1%Lung disorder
1%Pulmonary embolism
1%Appendicitis
1%Crohn's disease
1%Bile duct obstruction
1%Respiratory tract infection viral
1%Acute respiratory failure
1%Fluid overload
1%Basal cell carcinoma
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT02005471) in the Venetoclax + Rituximab ARM group. Side effects include: Neutropenia with 61%, Diarrhoea with 39%, Nausea with 21%, Upper respiratory tract infection with 21%, Fatigue with 18%.

Trial Design

1 Treatment Group

Treatment (venetoclax, ixazomib citrate, dexamethasone)
1 of 1
Experimental Treatment

6 Total Participants · 1 Treatment Group

Primary Treatment: Venetoclax · No Placebo Group · Phase 1

Treatment (venetoclax, ixazomib citrate, dexamethasone)Experimental Group · 4 Interventions: Bone Marrow Aspiration and Biopsy, Ixazomib Citrate, Dexamethasone, Venetoclax · Intervention Types: Procedure, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ixazomib
FDA approved
Dexamethasone
FDA approved
Venetoclax
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2.5 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,991 Previous Clinical Trials
41,298,487 Total Patients Enrolled
31 Trials studying Amyloidosis
2,145 Patients Enrolled for Amyloidosis
Michael A RosenzweigPrincipal InvestigatorCity of Hope Comprehensive Cancer Center LAO
3 Previous Clinical Trials
50 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have t(11;14) by FISH on bone marrow biopsy, to be confirmed at screening.
Children under 18 years of age are excluded from this study.
Leukocytes must be at least 3,000/mcL.
Platelets must be at least 75,000/mcL before study enrollment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 6th, 2021

Last Reviewed: October 19th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.