Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who Have Newly Diagnosed AL Amyloidosis

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Given IV

PROCEDURE

Biopsy

Undergo fat pad biopsy

PROCEDURE

Biospecimen Collection

Undergo blood and urine specimen collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

DRUG

Bortezomib

Given SC

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Cyclophosphamide

Given PO or IV

DRUG

Daratumumab and Hyaluronidase-fihj

Given SC

DRUG

Dexamethasone

Given PO or IV

PROCEDURE

Echocardiography

Undergo echocardiography

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Melphalan

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET-CT

PROCEDURE

Stem Cell Isolation

Undergo stem cell collection

OTHER

Survey Administration

Ancillary study

Major organ deterioration progression-free survival (PFS)

Time frame: From date of randomization (Step 2 registration) to date of first documentation of hematologic progression, cardiac organ progression, renal organ progression, or death due to any cause, assessed up to 4 years

Will be performed using a stratified log-rank test for comparison between study arms. The analyses will be stratified according to Mayo 2012 Prognostic Staging System for Light Chain Amyloidosis (Stage 1 versus \[vs.\] 2-3), hematological response following 2 cycles of daratumumab, cyclophosphamide, bortezomib and dexamethasone (Dara-VCD) induction (partial response \[PR\] or worse vs. very good partial response \[VGPR\] or better), and presence of t(11;14) by interphase fluorescence in situ hybridization \[iFISH\] (yes vs. no). All eligible participants will be considered in analyses of the primary endpoint, according to their assigned arm at randomization.

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.

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.

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.

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.

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.

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.