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Monoclonal Antibodies

Chemotherapy + Stem Cell Transplant for Amyloidosis

Phase 3
Recruiting
Led By Patrick A Hagen
Research Sponsored by SWOG Cancer Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 appearance by electron microscopy AND confirmatory AL amyloid typing (mass spectrometry-based proteomic analysis or immunofluorescence). If there is question regarding diagnosis, consult study chairs prior to registration
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of initial registration (step 1) and date of randomization (step 2 registration) to date of first documentation of hematologic pr, vgpr, or cr, assessed up to 4 years
Awards & highlights

Summary

This trial compares whether adding a stem cell transplant with melphalan after chemotherapy with daratumumab, cyclophosphamide, bortezomib, and dexamethasone (

Who is the study for?
This trial is for adults with newly diagnosed AL amyloidosis, confirmed by specific tests like urine and serum immunofixation electrophoresis, bone marrow analysis, and biopsy. Participants must have a certain level of light chain difference in their blood and can have had up to one cycle of prior therapy. They should be able to perform daily activities on their own or with some effort (ECOG score 0-2) but may be less mobile due to neuropathy.
What is being tested?
The study compares adding stem cell transplant after Dara-VCD chemotherapy (daratumumab, cyclophosphamide, bortezomib, dexamethasone) versus just the chemotherapy for treating AL amyloidosis. The goal is to see if the transplant helps kill more cancer cells when combined with melphalan chemo.
What are the potential side effects?
Potential side effects include reactions from monoclonal antibodies like daratumumab (infusion reactions), effects from steroids such as dexamethasone (immune system suppression), and general chemo side effects like nausea, fatigue, hair loss. Stem cell transplant risks involve infection risk due to immune suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My diagnosis of AL amyloidosis is confirmed by biopsy and specific tests.
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My bone marrow has cancerous cells and my blood test shows a specific protein imbalance.
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I am willing to undergo high dose chemotherapy and stem cell transplant if required.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of initial registration (step 1) and date of randomization (step 2 registration) to date of first documentation of hematologic pr, vgpr, or cr, assessed up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of initial registration (step 1) and date of randomization (step 2 registration) to date of first documentation of hematologic pr, vgpr, or cr, assessed up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Major organ deterioration progression-free survival (PFS)
Secondary study objectives
Best overall hematologic response
Cardiac and renal organ response rates
Change in patient reported health quality of life (QOL)
+8 more
Other study objectives
Bone marrow Next Generation Flow based MRD negativity rates
Change in PROMIS-29 fatigue domain score
Change in physical function as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29+2 physical function domain

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Maintenance (daratumumab and hyaluronidase-fihj)Experimental Treatment6 Interventions
Patients receive maintenance daratumumab and hyaluronidase-fihj SC over 3-5 minutes on day 1 of each cycle. Cycles repeat every 28 days for up 18 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography at screening, 12 months post consolidation treatment and at progression. Patients undergo bone marrow aspiration and biopsy 12 months post consolidation treatment and at progression. Patients undergo blood and urine sample collection at screening, during treatment, 12 months post consolidation treatment and during follow up or at progression.
Group II: Induction (Chemotherapy)Experimental Treatment13 Interventions
Patients receive daratumumab and hyaluronidase-fihj SC over 3-5 minutes on days 1, 8, 15 and 22 for 2 cycles and then days 1 and 15 for cycle 3. Patients receive bortezomib SC over 3-5 minutes, cyclophosphamide PO or IV, and dexamethasone PO or IV on days 1, 8, 15 and 22 of each cycle. Cycles repeat every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI or PET-CT and fat pad aspiration at screening. Patients undergo echocardiography at screening, the completion of induction, and at progression. Patients undergo bone marrow aspiration and biopsy at screening, post induction treatment and at progression. Patients undergo blood and urine sample collection at screening, at the start of each cycle, and the end of treatment and during follow up or at progression.
Group III: Consolidation Arm II (Chemotherapy, ASCT)Experimental Treatment8 Interventions
Patients undergo collection of peripheral blood stem cells. Patients receive melphalan IV for 1 cycle and then 2 days later receive the stem cell transplant IV in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography at screening and at progression. Patients undergo bone marrow aspiration and biopsy within 60-90 days post initiation of stem cell transplant. Patients undergo blood and urine sample collection at screening, during treatment, and the end of treatment and during follow up or at progression.
Group IV: Consolidation Arm I (Chemotherapy)Active Control9 Interventions
Patients receive daratumumab and hyaluronidase-fihj SC over 3-5 minutes on days 1 and 15 as well as bortezomib SC over 3-5 minutes, cyclophosphamide PO or IV, and dexamethasone PO or IV on days 1, 8, 15 and 22 of each cycle. Cycles repeat every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography at screening and at progression. Patients undergo bone marrow aspiration and biopsy within14-28 days post consolidation treatment and at progression. Patients undergo blood and urine sample collection at screening, at the start of each cycle, and the end of treatment and during follow up or at progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2640
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Biospecimen Collection
2004
Completed Phase 3
~2020
Bortezomib
2005
Completed Phase 3
~1410
Computed Tomography
2017
Completed Phase 2
~2740
Echocardiography
2013
Completed Phase 4
~11580
Melphalan
2008
Completed Phase 3
~1500
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Positron Emission Tomography
2011
Completed Phase 2
~2200
Bone Marrow Biopsy
2021
Completed Phase 3
~230
Cyclophosphamide
2010
Completed Phase 4
~2320
Biopsy
2014
Completed Phase 4
~1090
Autologous Hematopoietic Stem Cell Transplantation
2017
Completed Phase 3
~2090

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,662 Total Patients Enrolled
2 Trials studying AL Amyloidosis
35 Patients Enrolled for AL Amyloidosis
SWOG Cancer Research NetworkLead Sponsor
395 Previous Clinical Trials
264,736 Total Patients Enrolled
Patrick A HagenPrincipal InvestigatorSWOG Cancer Research Network
~225 spots leftby Jul 2030
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