Venetoclax MTD with Dexamethasone for Amyloidosis
Phase-Based Progress Estimates
Effectiveness
Safety
New York Presbyterian Hospital/Columbia University Irving Medical Center, New York, NY
Amyloidosis+4 More
Venetoclax MTD with Dexamethasone - DrugEligibility
18+
All Sexes
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Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary
The purpose of this study is assess safety, safest dose, and effectiveness of venetoclax in combination with dexamethasone in participants with t(11;14) positive relapsed (comes back) or refractory (did not get better) light chain amyloidosis.
Eligible Conditions
- Amyloidosis
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 9 Secondary · Reporting Duration: Up to 1 year
Year 1
Patient-reported outcomes (PROs) (Phase 2)
Up to 1 year
Duration of Hematologic Response (DOHR) (Phase 2)
Major Organ Deterioration-Progression Free Survival (MOD-PFS) (Phase 2)
Overall Hematologic Response Rate (HRR) (Phase 2)
Overall Organ Response Rate (ORR) (Phase 2)
Overall Survival (OS) (Phase 2)
Progression Free Survival (PFS) (Phase 2)
Time to hematologic ≥VGPR (Phase 2)
Time to next treatment (TTNT) (Phase 2)
Month 6
Hematologic ≥ Very Good Partial Response (VGPR) Rate (Phase 2)
Number of Participants with Dose Limiting Toxicities (DLT) (Phase 1)
Trial Safety
Safety Progress
Trial Design
6 Treatment Groups
Phase 2: Control Arm (Investigator's Choice)
1 of 6
Phase 1: Venetoclax 400mg + Dexamethasone 20 mg
1 of 6
Phase 1: Venetoclax 200 mg
1 of 6
Phase 1: Venetoclax 400mg + Dexamethasone 10 mg
1 of 6
Phase 1: Venetoclax 400mg
1 of 6
Phase 2: Venetoclax MTD with Dexamethasone
1 of 6
Active Control
Experimental Treatment
53 Total Participants · 6 Treatment Groups
Primary Treatment: Venetoclax MTD with Dexamethasone · No Placebo Group · Phase 1 & 2
Phase 1: Venetoclax 400mg + Dexamethasone 20 mgExperimental Group · 3 Interventions: FISH assay, Dexamethasone Oral, 20 mg, Venetoclax Oral Tablet, 400 mg · Intervention Types: Device, Drug, Drug
Phase 1: Venetoclax 200 mgExperimental Group · 2 Interventions: Venetoclax Oral Tablet, 200 mg, FISH assay · Intervention Types: Drug, Device
Phase 1: Venetoclax 400mg + Dexamethasone 10 mgExperimental Group · 3 Interventions: FISH assay, Dexamethasone Oral, 10 mg, Venetoclax Oral Tablet, 400 mg · Intervention Types: Device, Drug, Drug
Phase 1: Venetoclax 400mgExperimental Group · 2 Interventions: FISH assay, Venetoclax Oral Tablet, 400 mg · Intervention Types: Device, Drug
Phase 2: Venetoclax MTD with Dexamethasone
Drug
Experimental Group · 1 Intervention: Venetoclax MTD with Dexamethasone · Intervention Types: DrugPhase 2: Control Arm (Investigator's Choice)ActiveComparator Group · 5 Interventions: Ixazomib, Daratumumab Injection, Dexamethasone Oral, 20 mg, Bendamustine, Pomalidomide · Intervention Types: Drug, Drug, Drug, Drug, Drug
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year
Closest Location: New York Presbyterian Hospital/Columbia University Irving Medical Center · New York, NY
N/AFirst Recorded Clinical Trial
1 TrialsResearching Amyloidosis
0 CompletedClinical Trials
Who is running the clinical trial?
Rajshekhar Chakraborty, MDLead Sponsor
Genentech, Inc.Industry Sponsor
1,482 Previous Clinical Trials
563,292 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are 18 years or older at the time of signing the informed consent form.
You are able to comply with the study protocol.
You have a confirmed diagnosis of systemic AL amyloidosis.
You have received ≥1 prior lines of therapy, including an anti-CD38 monoclonal antibody.
You have had a history of autologous hematopoietic cell transplantation.
You have a performance status of 0, 1, or 2.
Presence of t(11;14) on FISH at any time since diagnosis.
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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