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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 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.

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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.

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

FieldValue
Enrollment Target 338 participants
Start Date 2024-07-01
Est. Completion 2030-10-29
Phase Phase 3

Sponsor

SWOG Cancer Research Network

270 total trials

What the Registry Record Tells You About NCT06022939

The ClinicalTrials.gov registry entry for NCT06022939 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 338 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 402-participant average among 15 other AL Amyloidosis trials with a reported enrollment target (16% lower). The listed sponsor is SWOG Cancer Research Network, which has 270 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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