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
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
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
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 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.
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