Active not recruitingPHASE3INTERVENTIONAL

S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duration

This study, called S1803, is for people in the UK with multiple myeloma who have had a stem cell transplant. It investigates two different treatment plans after the transplant, using either a drug called Lenalidomide alone, or Lenalidomide combined with another drug called Daratumumab. The main goal is to find out which treatment works better and for how long it should be given, especially after checking if any myeloma cells are still detectable (this is called 'minimal residual disease' or MRD). Patients will be followed closely for many years, and the treatment duration might change based on their MRD results. This research aims to improve how multiple myeloma is managed after a stem cell transplant.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

SWOG Cancer Research Network

Enrolment target

1,100

Start

13 Aug 2019

Estimated completion

01 Jul 2040

Multiple Myeloma

What is this study about?

This study is a clinical trial looking at different ways to treat multiple myeloma after patients have had a special procedure called an autologous stem cell transplant (ASCT). An ASCT is a treatment where a patient's own healthy stem cells are put back into their body after high-dose chemotherapy, to help their body recover and fight the cancer.

The study wants to understand the best way to continue treatment, often called 'maintenance' treatment, after the transplant. It compares two options: one group of patients will receive a drug called Lenalidomide, while another group will receive Lenalidomide combined with another drug called Daratumumab. These treatments are used to try and keep the multiple myeloma from coming back or getting worse.

After two years of this maintenance treatment, doctors will check for any remaining myeloma cells in the body, even very tiny amounts. This is called 'minimal residual disease' (MRD). The study will then use these results to decide whether patients should continue their treatment or if some might be able to safely stop. The study will follow patients for a long time, up to 15 years, to see how well these different approaches work and to improve future treatments for multiple myeloma.

Key takeaways

Compares two maintenance treatments for multiple myeloma after a stem cell transplant.
Uses Lenalidomide alone or with Daratumumab.
Treatment duration may change based on 'minimal residual disease' (MRD) results.
Follows patients for up to 15 years to understand long-term effects.
Aims to improve post-transplant care for multiple myeloma.

Who may be eligible?

To join this study, you need to have a confirmed diagnosis of multiple myeloma that caused symptoms and required chemotherapy before your stem cell transplant. You must have started your initial chemotherapy treatment within 12 months before signing up for the first part of the study, and have had at least two rounds of it. The study is for adults generally between 18 and 75 years old.

Before taking part, doctors will need to make sure your body is healthy enough for the study. This includes checking your kidney and liver function, and making sure you can safely take medication to prevent blood clots. You will also need to be able to move around reasonably well, as assessed by a doctor.

There are other medical details that your doctor will review to make sure this study is a good fit for you. It's important to discuss all your health conditions with your doctor if you are interested.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have you been diagnosed with symptomatic multiple myeloma?
Have you had an autologous stem cell transplant (ASCT)?
Are you generally between 18 and 75 years old?
Are your kidneys and liver working well?
Are you able to take medication to prevent blood clots?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll first go through a screening process, either before or after your stem cell transplant. Once everything is checked and you're ready for maintenance treatment, you'll be assigned by chance to one of two groups: either receiving Lenalidomide alone, or Lenalidomide with Daratumumab. You'll take this assigned treatment for two years.

After these two years, doctors will carefully check if any multiple myeloma cells are still present in your body (this is called MRD testing). If traces of myeloma are found, you will continue with the treatment you were assigned. If no traces are found, you'll then have another chance assignment: either continuing your treatment or stopping it. You will be closely monitored throughout this time, and the study plans to follow your health for up to 15 years in total to see the long-term effects of the treatments.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. A potential benefit of this study is that you might receive a new combination of treatments that could be more effective in controlling your multiple myeloma. Your health will also be closely monitored by a dedicated medical team. However, there are potential risks, such as side effects from the study medications, which your doctor will explain in detail. You are free to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (842)

Anchorage Associates in Radiation Medicine
Verified postcode
Anchorage, United States
Anchorage Radiation Therapy Center
Verified postcode
Anchorage, United States
Alaska Breast Care and Surgery LLC
Verified postcode
Anchorage, United States
Alaska Oncology and Hematology LLC
Verified postcode
Anchorage, United States
Alaska Women's Cancer Care
Verified postcode
Anchorage, United States
Anchorage Oncology Centre
Verified postcode
Anchorage, United States
Katmai Oncology Group
Verified postcode
Anchorage, United States
Providence Alaska Medical Center
Verified postcode
Anchorage, United States
Fairbanks Memorial Hospital
Verified postcode
Fairbanks, United States
Kingman Regional Medical Center
Verified postcode
Kingman, United States
Cancer Center at Saint Joseph's
Verified postcode
Phoenix, United States
Mayo Clinic Hospital in Arizona
Verified postcode
Phoenix, United States

Common questions

What is 'autologous stem cell transplant' (ASCT)?

An ASCT is a procedure where your own healthy blood stem cells are collected and then given back to you after high-dose chemotherapy to help your body recover.

What does 'MRD' mean?

MRD stands for 'minimal residual disease'. It means checking for very small numbers of myeloma cells that might still be in your body, even if they can't be seen on regular tests.

Will I know which treatment I'm getting?

Initially, you will be randomly assigned to one of the two treatment groups. After two years, if you are MRD-negative, you'll be randomly assigned again to either continue or stop your treatment.

How long will I be involved in the study?

Your active treatment may last for two years or longer, depending on your MRD results. The study will then follow your health for up to 15 years to see the long-term outcomes.

What are Lenalidomide and Daratumumab?

These are medications used to treat multiple myeloma. Lenalidomide is often used for maintenance, and Daratumumab is a type of immunotherapy that helps your immune system fight cancer cells.