Boston, MANCT07110844Now EnrollingIRB Ready

Amyloid Light-chain Amyloidosis Clinical Trial in Boston, MA

Access cutting-edge amyloid light-chain amyloidosis treatment through this phase 2 clinical trial at a research site in Boston. Study-provided care at no cost to qualified participants.

Sponsored by Suzanne Lentzsch, MD

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Expert Care in Boston

Access amyloid light-chain amyloidosis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related amyloid light-chain amyloidosis treatment provided free

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Check if you qualify for this amyloid light-chain amyloidosis clinical trial in Boston, MA

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Why Participate?

  • No-Cost Study Care

  • Local to Boston

    Convenient for MA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Boston site if eligible
  4. 4Begin participation

About This Amyloid Light-chain Amyloidosis Study in Boston

The purpose of this study is to investigate whether teclistamab-daratumumab combination is effective and safe in AL amyloidosis. The study treatment is divided into cycles (C) and each cycle is 28 days (D). Study treatment is expected to last 6 months.

Sponsor: Suzanne Lentzsch, MD

Who Can Participate

Inclusion Criteria

Age \>18 years and able to sign Informed Consent Form (ICF). If the individual being considered for participation in this study is unable to provide informed consent due to medical, cognitive, or other conditions, a legally authorized representative (LAR) may consent on their behalf.
Ability to comply with the study protocol, in the investigator's judgment.
Confirmed histopathological diagnosis of systemic AL amyloidosis by mass spectrometry or immunohistochemistry (IHC) or Immunofluorescence (IF) on a tissue biopsy that is positive for Congo Red.
Patient must not have received any prior plasma cell clone-directed therapy.
Measurable hematologic disease, defined as one of the following:
Difference between involved and uninvolved serum free light chain (dFLC) ≥50 mg/L and/or 5 mg/dL
Serum M-protein ≥0.5 g/dL on protein electrophoresis
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
One or more organs involved by AL amyloidosis as per consensus guidelines
Pre-treatment clinical laboratory values meeting the following criteria during the screening phase:
Absolute neutrophil count ≥0.75 × 10\^9/L
Hemoglobin level ≥8.0 g/dL; red blood cell transfusion allowed until 7 days before C1D0.
Platelet count ≥50 × 10\^9/L; Platelet transfusions are acceptable without restriction during the Screening period
Alanine aminotransferase level (ALT) ≤2.5 times the Upper Limit of Normal (ULN)
Aspartate aminotransferase (AST) ≤2.5 times the ULN
Total bilirubin level ≤1.5 × ULN except for subjects with Gilbert syndrome, in which case direct bilirubin ≤2 × ULN
Estimated glomerular filtration rate (eGFR) ≥20 mL/min/1.73 m\^2, measured by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs. For men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.

Exclusion Criteria

Prior therapy for AL amyloidosis or multiple myeloma with the exception of 160 mg dexamethasone (or equivalent corticosteroid) maximum exposure prior to C1D0.
Patients meeting criteria for symptomatic multiple myeloma by any one of the following: (a) Lytic lesions on imaging (Skeletal survey, whole body CT or MRI, or PET/CT) (b) Plasmacytoma, (c) Hypercalcemia without any alternate etiology, (d) Bone marrow plasma cell infiltrate of greater than 60%. Patients with involved/uninvolved serum FLC ratio\>100 as the sole myeloma-defining event will be allowed.
Evidence of significant cardiovascular conditions as specified below:
NT-Pro BNP \> 8500 pg/mL, and/or
NYHA Class IIIb or IV functional class
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
Patients with HIV who are not on HAART or those with active hepatitis A, B, or C infection.
Planned stem cell transplant during the first 6 cycles of protocol therapy are excluded. Stem cell collection during the first 6 cycles of protocol therapy is permitted, as per investigators' discretion.
Known hypersensitivity to any of the agents
Patients who are receiving any other investigational agent concurrently.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT07110844) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

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

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

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

Amyloid Light-chain Amyloidosis Treatment Options in Boston, MA

If you're searching for amyloid light-chain amyloidosis treatment options in Boston, MA, this clinical trial (NCT07110844) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced amyloid light-chain amyloidosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all amyloid light-chain amyloidosis clinical trials near you to find additional studies recruiting in your area.

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