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NCT05451771RECRUITINGIRB Ready

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

Sponsored by Rajshekhar Chakraborty, MD

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
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1 of 53 participants interested
2% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

Age โ‰ฅ 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 โ‰ฅ1 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 sq

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

53 participants

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Gender

ALL

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Sponsor

Rajshekhar Chakraborty, MD

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Boston

Massachusetts

Location available
View Boston location page
RECRUITING

Rochester

Minnesota

Location available
View Rochester location page
RECRUITING

New York

New York

Location available
View New York location page
RECRUITING

Milwaukee

Wisconsin

Location available
View Milwaukee location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Light Chain Amyloidosis Treatment in Boston?

Join others in Massachusetts exploring innovative treatment options through clinical research

Light Chain Amyloidosis Treatment Options in Boston, Massachusetts

If you're searching for Light Chain Amyloidosis treatment in Boston, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Boston, Rochester, New York and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Light Chain Amyloidosis. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Massachusetts
Now Enrolling
Up to 53 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Light Chain Amyloidosis?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Light Chain Amyloidosis

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Light Chain Amyloidosis Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05451771. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.