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NCT06022939 · ClinicalTrials.gov registry record · Phase 3
Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who Have Newly Diagnosed AL Amyloidosis
A Phase 3 study of AL Amyloidosis, sponsored by SWOG Cancer Research Network.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 338
- Enrollment target
- 20
- Study locations
NCT06022939: Recruiting Phase 3 study of AL Amyloidosis, sponsored by SWOG Cancer Research Network.
NCT06022939 is a Phase 3 study of AL Amyloidosis that is actively recruiting participants, run by SWOG Cancer Research Network. The registered enrollment target is 338 participants, below the 402-participant average among 15 other AL Amyloidosis trials with a reported enrollment target (16% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06022939, a Phase 3 study of AL Amyloidosis, is actively recruiting participants, sponsored by SWOG Cancer Research Network.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 338 participants
- Enrollment target
- 20
- Study locations
Study Summary
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. Giving chemotherapy before a peripheral blood stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. The stem cells are then returned to the patients to replace the blood forming cells that were destroyed by the chemotherapy. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Chemotherapy drugs, such as cyclophosphamide and bortezomib, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dexamethasone is in a class of medications called corticosteroids. It is used to lower the body's immune response to help stop the growth of cancer cells. Giving a stem cell transplant with melphalan after Dara-VCD may kill more cancer cells in patients with newly diagnosed AL amyloidosis.
Primary Outcome
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 hyb
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Biopsy
- PROCEDURE Autologous Hematopoietic Stem Cell Transplantation
Study Locations (20)
Connecticut
- Smilow Cancer Hospital-Derby Care Center - Derby
- Smilow Cancer Hospital Care Center - Guilford - Guilford
- Smilow Cancer Hospital Care Center at Saint Francis - Hartford
- Yale University - New Haven
- Yale-New Haven Hospital North Haven Medical Center - North Haven
Illinois
- Carle at The Riverfront - Danville
- Carle Physician Group-Effingham - Effingham
- Carle Physician Group-Mattoon/Charleston - Mattoon
- Loyola University Medical Center - Maywood
- Carle Cancer Center - Urbana
Iowa
- Mission Cancer and Blood - Ankeny - Ankeny
- Iowa Methodist Medical Center - Des Moines
- Mission Cancer and Blood - Des Moines - Des Moines
Kansas
- University of Kansas Cancer Center - Kansas City
- University of Kansas Hospital-Westwood Cancer Center - Westwood
Michigan
- Wayne State University/Karmanos Cancer Institute - Detroit
- Weisberg Cancer Treatment Center - Farmington Hills
Maryland
- Walter Reed National Military Medical Center - Bethesda
Massachusetts
- Boston Medical Center - Boston
Missouri
- Siteman Cancer Center at Saint Peters Hospital - City of Saint Peters
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 338 participants |
| Start Date | 2024-07-01 |
| Est. Completion | 2030-10-29 |
| Phase | Phase 3 |
What NCT06022939 shows while recruiting
NCT06022939 is an interventional study that assigns participants to a tested intervention. The registered 338 participants enrollment target is mid-sized for trials with a published cap, below the 402-participant average among 15 other AL Amyloidosis trials with a reported enrollment target (16% lower).
The record links to 1 condition, with AL Amyloidosis appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06022939 names 20 study sites across 8 states, led by Connecticut, Illinois, Iowa.
Frequently Asked Questions
What is clinical trial NCT06022939 about?
NCT06022939 is a clinical study titled "Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who Have Newly Diagnosed AL Amyloidosis". 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 (A...
What is the current status of trial NCT06022939?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 338 participants. The study started on 2024-07-01. Estimated completion is 2030-10-29.
What conditions does trial NCT06022939 study?
This clinical trial studies the following conditions: AL Amyloidosis.
What interventions are being tested in trial NCT06022939?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Biopsy (PROCEDURE), Autologous Hematopoietic Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT06022939?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06022939 being conducted?
This trial has 20 study locations across Connecticut, Illinois, Iowa, Kansas, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for AL Amyloidosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06022939's enrollment target sits among peer trials
338 2nd of 15 the highest of 15 other AL Amyloidosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other AL Amyloidosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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