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OncoMatch/Clinical Trials/NCT05451771

Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis

Is NCT05451771 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments for al amyloidosis.

Phase 1/2RecruitingRajshekhar Chakraborty, MDNCT05451771Data as of Jun 2026

Treatment: Venetoclax Oral Tablet, 200 mg · FISH assay · Venetoclax Oral Tablet, 400 mg · Dexamethasone Oral, 10 mg · Dexamethasone Oral, 20 mg · Daratumumab · Bendamustine · Pomalidomide · Ixazomib · Venetoclax MTD with DexamethasoneThe 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.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Daratumumab

Targeted therapy

Ixazomib

Chemotherapy

Bendamustine

Endocrine / hormonal

Pomalidomide

Other

Venetoclax Oral Tablet, 200 mgFISH assayVenetoclax Oral Tablet, 400 mgDexamethasone Oral, 10 mgDexamethasone Oral, 20 mgVenetoclax MTD with Dexamethasone

Cancer type

Multiple Myeloma

Biomarker criteria

Required: CCND1 t(11;14) translocation

Disease stage

Excluded: Stage MAYO STAGE THREE-B (IIIB) WITH NT-PRO BNP > 8500 PG/ML

Mayo stage three-B (IIIB) with N-terminal pro-hormone B-type natriuretic peptide (NT-Pro BNP) > 8500 pg/mL

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: anti-CD38 monoclonal antibody

Has received ≥1 prior lines of therapy, including an anti-cluster of differentiation 38 (CD 38) monoclonal antibody

Cannot have received: BCL2 inhibitor

Prior exposure to anti-apoptotic protein B-cell lymphoma 2 (BCL-2) inhibitors

Lab requirements

Cardiac function

New York Heart Association (NYHA) Class III or IV heart failure [excluded]

Patients on renal replacement therapy; New York Heart Association (NYHA) Class III or IV heart failure

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Boston Medical Center · Boston, Massachusetts
  • Mayo Clinic Rochester · Rochester, Minnesota
  • New York Presbyterian Hospital/Columbia University Irving Medical Center · New York, New York
  • Froedtert Hospital & the Medical College of Wisconsin · Milwaukee, Wisconsin

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT05451771 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior BCL2 inhibitor disqualifies patients from enrollment.

Does this trial require CCND1?

Yes, CCND1 t(11;14) translocation is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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