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

Launched by RAJSHEKHAR CHAKRABORTY, MD · Jul 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a combination of two medications, venetoclax and dexamethasone, in patients with a specific type of AL amyloidosis called t(11;14) positive relapsed or refractory light chain amyloidosis. The main goals of the study are to find out how safe this treatment is, determine the best dose, and see how effective it might be in helping patients whose disease has come back or did not improve with previous treatments.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of systemic AL amyloidosis. They should have already tried at least one treatment before, and their disease must show the specific genetic marker t(11;14). Participants will receive the study treatment and be closely monitored for any side effects and how well the treatment works. This trial is currently recruiting participants, and it is important to note that certain health conditions or previous treatments may prevent someone from joining. If you or a loved one are interested, discussing it with a healthcare professional can provide more personalized information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years at time of signing Informed Consent Form
• • Ability to comply with the study protocol, in the investigator's judgment
• • Confirmed diagnosis of systemic AL amyloidosis by mass spectrometry or immunohistochemistry (IHC) on a tissue biopsy
• • Has received ≥1 prior lines of therapy, including an anti-cluster of differentiation 38 (CD 38) monoclonal antibody
• • Participants with a history of autologous hematopoietic cell transplantation must have recovered from any transplant-related toxicities
• • Presence of t(11;14) on FISH at any time since diagnosis (Eligibility must confirmed by FISH testing at Columbia University Irving Medical Center (CUIMC)
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Exclusion Criteria:
• • Known hypersensitivity to any of the study drugs
• • History of other malignancy that could affect compliance with the protocol or interpretation of results (Patients with a history of curatively treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix, breast cancer, or Hodgkin's Lymphoma are generally eligible. Patients with a malignancy that has been treated, but not with curative intent, will be excluded, unless the malignancy has been in remission without treatment for ≥ 2 years prior to enrollment.)
• • Evidence of other clinically significant uncontrolled condition(s) including, but not limited to, uncontrolled systemic infection (viral, bacterial, or fungal)
• • Patients on renal replacement therapy
• • Known GI disease or GI procedure that could interfere with oral absorption (including difficulty swallowing)
• • New York Heart Association (NYHA) Class III or IV heart failure
• • Mayo stage three-B (IIIB) with N-terminal pro-hormone B-type natriuretic peptide (NT-Pro BNP) \> 8500 pg/mL
• • Prior exposure to anti-apoptotic protein B-cell lymphoma 2 (BCL-2) inhibitors
• • Patients with human immunodeficiency virus (HIV) who are not on highly active antiretroviral therapy (HAART) or those with active hepatitis A, B, or C infection
• • Patients meeting criteria for symptomatic multiple myeloma by one of the following:(a) Lytic lesions on imaging (b) Plasmacytoma, (c) Hypercalcemia without any alternate etiology, or (c) Bone marrow plasma cell infiltrate of greater than 60%