338 Participants Needed

Chemotherapy + Stem Cell Transplant for Amyloidosis

Recruiting at 34 trial locations
AF
Overseen ByAdam F. Binder
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: SWOG Cancer Research Network
Must be taking: Daratumumab, Cyclophosphamide, Bortezomib, Dexamethasone
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you may continue taking chronic corticosteroids if they are for conditions other than AL amyloidosis or myeloma. It's best to discuss your specific medications with the study team.

Is the combination of chemotherapy and stem cell transplant for amyloidosis safe?

Daratumumab, when used in combination with other chemotherapy drugs for treating amyloidosis, has been shown to have a tolerable safety profile with no significant treatment-related adverse events reported in multiple studies. It is generally well tolerated, and no new safety concerns were identified compared to its use in other conditions.12345

How is the drug Daratumumab used in treating amyloidosis different from other treatments?

Daratumumab, when combined with other drugs like bortezomib, cyclophosphamide, and dexamethasone, offers a unique treatment for amyloidosis by targeting a specific protein (CD38) on cells, leading to improved blood and organ responses. This combination is particularly effective for patients who are newly diagnosed or have relapsed, providing a promising option with a good safety profile compared to traditional treatments.12346

What data supports the effectiveness of the drug Daratumumab for treating AL amyloidosis?

Research shows that Daratumumab, when used alone or with other drugs, significantly improves blood and organ responses in patients with AL amyloidosis. It has been effective in both newly diagnosed and previously treated patients, with studies showing high rates of response and good tolerability.12478

Who Is on the Research Team?

PA

Patrick A Hagen

Principal Investigator

SWOG Cancer Research Network

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My diagnosis of AL amyloidosis is confirmed by biopsy and specific tests.
You have a positive monoclonal serum immunofixation electrophoresis result.
My bone marrow has cancerous cells and my blood test shows a specific protein imbalance.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Induction

Participants receive daratumumab, cyclophosphamide, bortezomib, and dexamethasone for up to 3 cycles

12 weeks
4 visits per cycle (in-person)

Consolidation

Participants receive additional cycles of chemotherapy or undergo stem cell transplant

12 weeks
4 visits per cycle (in-person)

Maintenance

Participants receive maintenance daratumumab and hyaluronidase-fihj for up to 18 cycles

72 weeks
1 visit per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 4 years
Every 3 or 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Daratumumab
  • Melphalan
Trial Overview 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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Group I: Maintenance (daratumumab and hyaluronidase-fihj)Experimental Treatment6 Interventions
Group II: Induction (Chemotherapy)Experimental Treatment13 Interventions
Group III: Consolidation Arm II (Chemotherapy, ASCT)Experimental Treatment8 Interventions
Group IV: Consolidation Arm I (Chemotherapy)Active Control9 Interventions

Daratumumab is already approved in European Union, United States for the following indications:

๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Darzalex for:
๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Darzalex for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

SWOG Cancer Research Network

Lead Sponsor

Trials
403
Recruited
267,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Daratumumab (Dara) has shown remarkable efficacy and a tolerable safety profile in treating newly diagnosed and relapsed refractory AL amyloidosis, making it a promising treatment option for patients who are often ineligible for intensive therapies.
The review highlights the importance of timely diagnosis and the use of novel therapies like Dara, which have contributed to improved outcomes for patients with systemic light-chain amyloidosis over the past two decades.
Progress in research: Daratumumab improves treatment outcomes of patients with AL amyloidosis.Hassan, H., Anwer, F., Javaid, A., et al.[2021]
In the phase III ANDROMEDA trial, subcutaneous daratumumab combined with bortezomib, cyclophosphamide, and dexamethasone significantly improved the rate of complete hematological response in patients with newly diagnosed systemic AL amyloidosis compared to the standard treatment alone.
This combination therapy not only produced rapid and deep responses but also resulted in better progression-free survival and higher rates of cardiac and renal responses at 6 and 12 months, while maintaining an acceptable safety profile.
Daratumumab: A Review in Newly Diagnosed Systemic Light Chain Amyloidosis.Blair, HA.[2022]
Daratumumab shows promising efficacy in treating AL amyloidosis, with hematologic responses observed in 50%-90% of patients and organ responses (cardiac/renal) in 50%-80% based on a review of 16 studies.
The treatment is well tolerated, with no significant treatment-related adverse events reported, making it a safe option for both newly diagnosed and relapsed refractory AL amyloidosis patients.
Efficacy and Safety of Daratumumab-based Regimens in Pretreated Light Chain (AL) Amyloidosis: A Systematic Review.Ehsan, H., Rafae, A., Masood, A., et al.[2022]

Citations

Progress in research: Daratumumab improves treatment outcomes of patients with AL amyloidosis. [2021]
Daratumumab: A Review in Newly Diagnosed Systemic Light Chain Amyloidosis. [2022]
Efficacy and Safety of Daratumumab-based Regimens in Pretreated Light Chain (AL) Amyloidosis: A Systematic Review. [2022]
Daratumumab for the treatment of AL amyloidosis. [2023]
High rate of profound clonal and renal responses with daratumumab treatment in heavily pre-treated patients with light chain (AL) amyloidosis and high bone marrow plasma cell infiltrate. [2020]
Daratumumab plus CyBorD for patients with newly diagnosed AL amyloidosis: safety run-in results of ANDROMEDA. [2021]
Population Pharmacokinetics and Exposure-Response Modeling of Daratumumab Subcutaneous Administration in Patients With Light-Chain Amyloidosis. [2022]
The Role of Autologous Stem Cell Transplantation in Amyloidosis. [2022]
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