Recruiting PHASE3 AL Amyloidosis

Compares treatment options for AL Amyloidosis

Q: Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Q: Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

Q: How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Q: Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Q: Where is this trial taking place?

Study sites include Goodyear, Arizona, United States; Tucson, Arizona, United States; Duarte, California, United States; Irvine, California, United States; Orange, California, United States; Derby, Connecticut, United States and 90 more location(s). Enter your location above to see the nearest site and check your eligibility.

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

ClinicalTrials.gov ID: NCT06022939

What this study is testing

What is Bortezomib?

Bortezomib is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for al amyloidosis.

Also referred to as [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid, LDP 341.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing: This phase III trial compares the effect of adding a stem cell transplant with melphalan after completing chemotherapy with daratumumab, cyclophosphamide, bortezomib and dexamethasone (Dara-VCD) versus chemotherapy with Dara-VCD alone for treating patients with newly diagnosed amyloid light chain (AL) amyloidosis. Melphalan is a chemotherapy given prior to a stem cell transplant.

Phase 3: a large, late-stage study
Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

STEP 1: Participants must have systemic AL amyloidosis which is biopsy proven and includes histologically-confirmed by positive Congo red stain with...
STEP 1: Participants must have measurable disease within 28 days prior to treatment if initiated prior to registration or within 28 days of...
Positive monoclonal serum immunofixation electrophoresis
Positive monoclonal urine immunofixation electrophoresis
Monoclonal plasma cells in bone marrow In addition, participants must also have a difference between the involved and uninvolved free light chain...

See the full eligibility criteria

Who can join

STEP 1: Participants must have systemic AL amyloidosis which is biopsy proven and includes histologically-confirmed by positive Congo red stain with green birefringence on polarized light microscopy, OR characteristic...
STEP 1: Participants must have measurable disease within 28 days prior to treatment if initiated prior to registration or within 28 days of registration as defined by at least one of the following:
Positive monoclonal serum immunofixation electrophoresis
Positive monoclonal urine immunofixation electrophoresis
Monoclonal plasma cells in bone marrow In addition, participants must also have a difference between the involved and uninvolved free light chain (dFLC) \>= 2 mg/dL
STEP 1: Participants may receive up to one cycle (or 28 days) of therapy prior to enrollment. If a patient receives \>= 75% of 1 cycle of protocol identical Dara-VCD, this will be considered 1 cycle of protocol...
STEP 1: Participants may be receiving chronic corticosteroids if they are being given for disorders other than AL amyloidosis or myeloma
STEP 1: Participant must be \>= 18 years old
STEP 1: Participant must have Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0, 1, or 2 (PS = 3 may be allowed if secondary to neuropathy)
STEP 1: Participant must have a complete medical history and physical exam within 28 DAYS prior to registration
STEP 1: Participants must be willing to undergo high dose chemotherapy and autologous stem cell transplantation if they are assigned by chance to the arm receiving high dose chemotherapy and autologous stem cell...
STEP 1: Participants must be eligible to receive high dose chemotherapy with melphalan at a dose of 200 mg/m\^2 or 140 mg/m\^2 (200 mg/m\^2 is highly encouraged but not mandated). Transplant eligibility criteria are...
Participant must have a supine systolic blood pressure (BP) \>= 90 mmHg (at registration step-1, this may by supported by midodrine
Participant must have non-severe cardiac AL (meeting all the below criteria) as defined by:
N-terminal proB-type natriuretic peptide (NT proBNP) \< 5000 (if no NTproBNP, brain natriuretic peptide [BNP] must be available and \< 400)
Troponin T (TnT) \< 0.06. If not available, one of the following two criteria must be met:
High sensitivity troponin (hsTnT) T \< 75 or troponin I \< 0.1ng/dL
New York Heart Association (NYHA) I or II
Cardiac ejection fraction (EF) \>= 40%
STEP 1: Hemoglobin \>= 8.0 g/dL (\> 5 mmol/L); red blood cell transfusion allowed up to 7 day prior to registration (within 28 days prior to registration) (NOTE: Growth factor support granulocyte colony-stimulating...
STEP 1: Leukocytes \>= 2 x 10\^3/uL (within 28 days prior to registration) (NOTE: Growth factor support [G-CSF] is permitted per institutional guidelines)
STEP 1: Absolute neutrophil count \>= 1.0 x 10\^3/uL (within 28 days prior to registration) (NOTE: Growth factor support [G-CSF] is permitted per institutional guidelines)
STEP 1: Platelets \>= 50 x 10\^3/uL (within 28 days prior to registration) (NOTE: Growth factor support [G-CSF] is permitted per institutional guidelines)
STEP 1: Total bilirubin =\< 1.5 times the institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional ULN...
STEP 1: Direct bilirubin =\< 2.0 mg/dL (within 28 days prior to registration)
STEP 1: Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) =\< 3x upper limit of normal (ULN) (except if secondary to hepatic involvement) (within 28 days prior to registration)
STEP 1: Alkaline phosphatase =\< 750 U/L (except if secondary to hepatic involvement) (within 28 days prior to registration)
STEP 1: Participants must have a serum creatinine =\ = 30 mL/min using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to registration
STEP 1: If peripheral neuropathy is present at diagnosis, participants must be grade 2 (moderate symptoms; limiting instrumental activity of daily living [ADL]) or less
STEP 1: Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of...
STEP 1: Participants must not be seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). people with resolved infection (i.e., people who are HBsAg negative but positive for...
STEP 1: Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most...
STEP 1: Participants must not have concurrent multiple myeloma as defined by the presence of lytic bone disease, plasmacytomas, \>= 60% plasma cells in the bone marrow, or hypercalcemia. Participants will not be...
STEP 1: Participants must not have known allergies to any of the study drugs
STEP 1: Participants must not have had a major surgery within 14 days prior to registration and be fully recovered from surgery completed within 14 days prior to registration
STEP 1: Participants must not have a known chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) \< 50% of predicted normal
STEP 1: Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained...
STEP 1: Participants must not have either moderate or severe persistent asthma within the past 2 years), or currently have uncontrolled asthma of any classification. (Note that people who currently have controlled...
STEP 1: Participants must not have uncontrolled diabetes within 28 days prior to registration
STEP 1: Participants must not have uncontrolled blood pressure and hypertension within 14 days prior to registration. Participants must have a supine systolic BP of \>= 90 mmHg
STEP 1: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or how well it works...
STEP 1: Participants must not have received vaccination with live attenuated vaccines within 28 days prior to Registration to Step 1
STEP 1: Participants must not have uncontrolled infection at the discretion of the enrolling physician and to be discussed with the study chair if the participant is on active anti-infectious therapy. Any patient on...
STEP 1: Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive...
STEP 1: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwestern Oncology group (SWOG) Specimen Tracking...
STEP 1: Participants must agree to have blood, bone marrow core biopsy and aspirate, and fat pad biopsy specimens submitted for minimal residual disease assessment and future exploratory studies
STEP 1: Participants who can complete PRO, QOL, PRO-CTCAE questionnaires, etc. forms in English, Spanish and French must participate in the patient-reported outcomes and quality of life
STEP 2: Participants must have met all eligibility criteria for Step-1 registration
STEP 2: Participants must have achieved at least a partial response
STEP 2: Participants must continue receiving at least one of study drugs (bortezomib, cyclophosphamide, or daratumumab and hyaluronidase-fihj) if another study drug (daratumumab and hyaluronidase-fihj, cyclophosphamide...
STEP 2: Participants must have completed induction therapy
STEP 2: Participants must be registered to Step 2 within 42 days of cycle 3, day 28 of induction therapy
STEP 2: Participants must plan to initiate their assigned consolidation therapy within 8 weeks after randomization
STEP 2: Participants must not have experienced a MOD-PFS event
STEP 2: Participants must have ECOG performance score (PS) of 0, 1, or 2 (PS = 3 may be allowed if secondary to neuropathy)
STEP 2: Participant must have a complete medical history and physical exam within 28 days prior to registration
STEP 2: Participants must be willing to undergo high dose chemotherapy and autologous stem cell transplantation if they are assigned by chance to the arm receiving high dose chemotherapy and autologous stem cell...
STEP 2: Participants assigned by chance to Arm 2 must be willing and able to return to a participating treatment center for their assigned treatment after transplant. Note that participants need not to have a direct...
STEP 2: Participants must be eligible to receive high dose chemotherapy with melphalan at a dose of 200 mg/m\^2 or 140 mg/m\^2 (200 mg/m\^2 is highly encouraged but not mandated). Transplant eligibility criteria are...
Patient must have a supine systolic BP \>= 90 mmHg (at registration step-1, this may not by supported by midodrine)
Patient must have non-severe cardiac AL as defined by:
NT proBNP \<5000 (if no NTproBNP, BNP must be available and \< 400 pg/mL) (within 14 days prior to registration step-2)
TnT \< 0.06. If not available, one of the following two criteria must be met (within 14 days prior to registration step-2)
hsTnT \<75 or troponin I \< 0.1ng/dL
NYHA I or II (within 14 days prior to registration step-2)
Cardiac EF \>= 40% (within 14 days prior to registration step-2)
STEP 2: Hemoglobin \> 8.0 g/dL (\> 5 mmol/L); red blood cell transfusion allowed up to 7 days prior to registration (within 28 days prior to registration) (NOTE: Growth factor support [G-CSF] is permitted per...
STEP 2: Leukocytes \>= 2 x 10\^3/uL (within 28 days prior to registration) (NOTE: Growth factor support [G-CSF] is permitted per institutional guidelines)
STEP 2: Absolute neutrophil count \>= 1.0 x 10\^3/uL (within 28 days prior to registration) (NOTE: Growth factor support [G-CSF] is permitted per institutional guidelines)
STEP 2: Platelets \>= 50 x 10\^3/uL (within 28 days prior to registration) (NOTE: Growth factor support [G-CSF] is permitted per institutional guidelines)
STEP 2: Total bilirubin =\< 1.5 times the institutional ULN unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional ULN (within 28 days prior...
STEP 2: Direct bilirubin =\< 2.0 mg/dL (except if secondary to hepatic involvement) (within 28 days prior to registration)
STEP 2: AST/ALT =\< 3x upper limit of normal (ULN) (except if secondary to hepatic involvement) (within 28 days prior to registration)
STEP 2: Alkaline phosphatase =\< 750 U/L (except if secondary to hepatic involvement) (within 28 days prior to registration)
STEP 2: Participants must have a serum creatinine =\< the IULN OR calculated creatinine clearance ≥ 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days...
STEP 2: Participants must not have uncontrolled infection at the discretion of the enrolling physician and to be discussed with the study chair if the participant is on active anti-infectious therapy. Any patient on...
STEP 2: Participants assigned by chance to the ASCT arm must be able to have at least 2.0 x 10\^6 CD34 cells/kg collected
STEP 2: Participants who can complete PRO, QOL, PRO-CTCAE questionnaires, etc. forms in English, Spanish and French must participate in the patient-reported outcomes and quality of life
STEP 3: Participants must have met all eligibility criteria for Step-1 and Step-2 registration
STEP 3: Participants must not have had daratumumab and hyaluronidase-fihj permanently discontinued during induction or consolidation
STEP 3: Participants must have completed induction and consolidation therapy
STEP 3: Participants must be registered to Step 3 within the following time frames:
If assigned by chance to Arm 1 Dara-VCD consolidation: within 28 days of completion of 3 cycles of consolidation therapy
If assigned by chance to Arm 2 high dose chemotherapy and autologous stem cell transplantation: within 180 days following initiation of stem cell transplantation
STEP 3: Participants must not have experienced a MOD-PFS event
STEP 3: Participants must have ECOG performance score (PS) of 0, 1, or 2 (PS = 3 is allowed if secondary to neuropathy)
STEP 3: Participants must have a complete medical history and physical exam within 28 DAYS prior to registration
STEP 3: Hemoglobin \> 8.0 g/dL (\> 5 mmol/L); red blood cell transfusion allowed up to 7 days prior to registration (within 28 days prior to registration) (NOTE: Growth factor support [G-CSF] is permitted per...
STEP 3: Leukocytes \>= 2 x 10\^3/uL (within 28 days prior to registration) (NOTE: Growth factor support [G-CSF] is permitted per institutional guidelines)
STEP 3: Absolute neutrophil count \>= 1.0 x 10\^3/uL (within 28 days prior to registration) (NOTE: Growth factor support [G-CSF] is permitted per institutional guidelines)
STEP 3: Platelets \>= 50 x 10\^3/uL (within 28 days prior to registration) (NOTE: Growth factor support [G-CSF] is permitted per institutional guidelines)
STEP 3: Total bilirubin =\< 1.5 times the institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional ULN...
STEP 3: Direct bilirubin =\< 2.0 mg/dL (within 28 days prior to registration)
STEP 3: AST/ALT =\< 3x upper limit of normal (ULN) (except if secondary to hepatic involvement) (within 28 days prior to registration)
STEP 3: Alkaline phosphatase =\< 750 U/L (except if secondary to hepatic involvement) (within 28 days prior to registration)
STEP 3: Participants must not have uncontrolled infection at the discretion of the enrolling physician and to be discussed with the study chair if the participant is on active anti-infectious therapy. Any patient on...
Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making...

The study team makes the final eligibility decision.

Where it's taking place

Goodyear, Arizona, United States
Tucson, Arizona, United States
Duarte, California, United States
Irvine, California, United States
Orange, California, United States
Derby, Connecticut, United States
Greenwich, Connecticut, United States
Guilford, Connecticut, United States
Hartford, Connecticut, United States
New Haven, Connecticut, United States
North Haven, Connecticut, United States
Stamford, Connecticut, United States
Trumbull, Connecticut, United States
Washington D.C., District of Columbia, United States
Aventura, Florida, United States
Coral Gables, Florida, United States
Coral Springs, Florida, United States
Deerfield Beach, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States

+ 76 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Goodyear, Arizona, United States; Tucson, Arizona, United States; Duarte, California, United States; Irvine, California, United States; Orange, California, United States; Derby, Connecticut, United States and 90 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.