Venetoclax for Multiple Myeloma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Multiple Myeloma+1 More
Venetoclax - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying whether a combination of venetoclax and dexamethasone is better than pomalidomide and dexamethasone at treating patients with relapsed or refractory multiple myeloma.

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 20 Secondary · Reporting Duration: Up to approximately 51 months from first randomization

Day 225
Cmax of Venetoclax
Trough Concentration (Ctrough) of Venetoclax
Month 43
Duration of response (DOR)
Minimal Residual Disease (MRD) Negativity Rate
Overall Response Rate (ORR)
Progression-Free Survival (PFS)
Time to Disease Progression (TTP)
Time to Response (TTR)
Very Good Partial Response or Better Response Rate (VGPR)
Month 51
Change from Baseline in BPI-SF Worst Pain Score
Change from Baseline in EORTC QLQ-30 Global Health Status/Quality of Life Score
Change from Baseline in EORTC QLQ-30 Physical Functioning Score
Change from Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L)
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Module 20 (EORTC QLQ-MY20)
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Change from Baseline in PROMIS Fatigue Score
Change from Baseline in PROMIS Fatigue Score.
Number of Participants With Adverse Events (AEs)
Overall survival (OS)
Time to Deterioration in Disease Symptoms
Time to Deterioration in Physical Functioning

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

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%Sepsis
1%Respiratory tract infection
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

2 Treatment Groups

Arm 2 PomDex
1 of 2
Arm 1 VenDex
1 of 2

Active Control

Experimental Treatment

244 Total Participants · 2 Treatment Groups

Primary Treatment: Venetoclax · No Placebo Group · Phase 3

Arm 1 VenDexExperimental Group · 2 Interventions: Venetoclax, Dexamethasone · Intervention Types: Drug, Drug
Arm 2 PomDexActiveComparator Group · 2 Interventions: Pomalidomide, Dexamethasone · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
FDA approved
Dexamethasone
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 51 months from first randomization

Who is running the clinical trial?

Roche-GenentechIndustry Sponsor
20 Previous Clinical Trials
2,414 Total Patients Enrolled
AbbVieLead Sponsor
823 Previous Clinical Trials
469,391 Total Patients Enrolled
32 Trials studying Multiple Myeloma
4,721 Patients Enrolled for Multiple Myeloma
ABBVIE INC.Study DirectorAbbVie
295 Previous Clinical Trials
116,905 Total Patients Enrolled
12 Trials studying Multiple Myeloma
1,823 Patients Enrolled for Multiple Myeloma

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a documented diagnosis of MM based on standard IMWG criteria.
You have received at least 2 consecutive cycles of a proteasome inhibitor.
You have received at least 2 prior lines of therapy as described in the protocol.
You have had a disease progression on or within 60 days after completion of the last therapy.
Liver, kidney and hematology laboratory values that meet criteria as described per protocol.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 10th, 2021

Last Reviewed: November 3rd, 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.

Who else is applying?

What state do they live in?
British Columbia50.0%
Michigan50.0%
How old are they?
65+50.0%
18 - 6550.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
What site did they apply to?
BC Cancer - Vancouver /ID# 222804100.0%