Study on Treatment-Free Intervals for Newly Diagnosed Multiple Myeloma Patients Using Daratumumab, Lenalidomide, and Dexamethasone

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What is this study about?

This clinical trial is focused on studying multiple myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The study will use a combination of three treatments: lenalidomide, daratumumab, and dexamethasone. Lenalidomide is taken as a capsule, daratumumab is given as an injection, and dexamethasone is taken as a soluble tablet. The purpose of the study is to explore the possibility of having a break from treatment for patients who have been newly diagnosed with multiple myeloma and have already received a specific combination of these treatments.

Participants in the study will be divided into two groups. One group will continue receiving the combination of daratumumab, lenalidomide, and dexamethasone without interruption. The other group will stop the treatment for a period and then resume it if there are signs that the disease is progressing. The study will monitor how long patients remain free from events like disease progression or the need to restart treatment, as well as their overall quality of life during the study period.

The trial aims to understand the effects of taking a break from treatment and how it impacts the progression of multiple myeloma. It will also look at the side effects and overall health of the participants. The study will help determine if a treatment-free interval is a viable option for managing multiple myeloma in newly diagnosed patients.

1 joining the study

Upon joining the study, the patient must have been diagnosed with multiple myeloma and have completed 12 cycles of treatment with daratumumab, lenalidomide, and dexamethasone (Dara-Rd).

The patient must be at least 18 years old and capable of providing informed consent.

2 randomization

The patient will be randomly assigned to one of two groups: continuous therapy or discontinuation of therapy.

In the continuous therapy group, the patient will continue receiving Dara-Rd until the disease progresses.

3 treatment administration

For those in the continuous therapy group, lenalidomide is taken orally, with a reduced dose allowed but not less than 5 mg per day.

Daratumumab is administered via subcutaneous injection.

Dexamethasone is taken orally, with previous dose reductions allowed.

4 monitoring and evaluation

The patient’s health and response to treatment will be regularly monitored to assess event-free survival and progression-free survival.

The study will evaluate the time to response and maximal response after restarting therapy in the discontinuation group.

5 treatment-free interval

For patients in the discontinuation group, therapy will be paused until biochemical progression is observed.

Upon progression, therapy with Dara-Rd will resume until further disease progression.

6 end of study

The study is estimated to conclude by September 8, 2030.

The primary endpoints include event-free survival and progression-free survival, while secondary endpoints focus on quality of life, treatment-free intervals, and overall survival.

Who Can Join the Study?

  • The patient must have been diagnosed with multiple myeloma, a type of cancer that affects certain blood cells, based on specific criteria and have measurable disease at the time of diagnosis.
  • The patient must be at least 18 years old.
  • The patient must have been treated with 12 cycles (or 13 cycles) of a specific therapy called Dara-Rd and be eligible to continue this treatment. It’s okay if the dose of one of the drugs, lenalidomide, was reduced, but it should not be less than 5 mg per day. Previous reduction or stopping of another drug, dexamethasone, is also allowed.
  • The patient must have achieved a partial response (PR) or better after 12 cycles of Dara-Rd treatment, without any signs of the disease getting worse based on lab tests.
  • The patient must have a certain level of white blood cells (ANC ≥ 1.0×109/L) and platelets (≥ 75×109/L), which are important for fighting infections and blood clotting.
  • The patient must be able to understand and agree to participate in the study, which means they can give informed consent.
  • The patient must provide written informed consent, which is a document that confirms they understand the study and agree to take part in it.

Who Cannot Join the Study?

  • Patients with conditions other than multiple myeloma cannot participate. Multiple myeloma is a type of cancer that affects certain blood cells in the bone marrow.
  • Patients who are not within the specified age range cannot participate. The age range for this study is typically adults.
  • Both male and female patients are eligible, so gender is not a reason for exclusion.
  • Patients who are considered part of a vulnerable population, such as those unable to give consent, are not included in this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Stichting OLVG Amsterdam The Netherlands
Frisius Heerenveen The Netherlands
University Hospital Maastricht Maastricht The Netherlands

Other Sites

Site Name City Country Status
Ziekenhuis Gelderse Vallei Stichting Ede The Netherlands
Haga Hospital Hague The Netherlands
Noordwest Ziekenhuisgroep Stichting Alkmaar The Netherlands
Isala Klinieken Stichting Zwolle The Netherlands
Groene Hart Ziekenhuis Gouda The Netherlands
Jeroen Bosch Ziekenhuis Stichting s-Hertogenbosch The Netherlands
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
Amphia Hospital Breda The Netherlands
Tergooiziekenhuizen Hilversum The Netherlands
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
Ziekenhuis Rivierenland Tiel The Netherlands
Stichting Viecuri Medisch Centrum voor Noord-Limburg Venlo The Netherlands
Spaarne Gasthuis Hoofddorp The Netherlands
Medisch Spectrum Twente Enschede The Netherlands
Diakonessenhuis Stichting Utrecht The Netherlands
Ziekenhuisgroep Twente Stichting Almelo The Netherlands
Elkerliek Ziekenhuis Helmond The Netherlands
ZorgSaam Ziekenhuis Terneuzen The Netherlands
Ziekenhuis St Jansdal Harderwijk The Netherlands
Alrijne Zorggroep Stichting Leiderdorp The Netherlands
Ikazia Ziekenhuis Rotterdam The Netherlands
Het Van Weel-Bethesda Ziekenhuis Dirksland The Netherlands
Ziekenhuis Nij Smellinghe Drachten The Netherlands
Ziekenhuis Amstelland Amstelveen The Netherlands
Rode Kruis Ziekenhuis B.V. Beverwijk The Netherlands
Saxenburgh Medisch Centrum Hardenberg The Netherlands
Bernhoven B.V. Uden The Netherlands
Flevoziekenhuis Stichting Almere The Netherlands
Maxima Medisch Centrum Veldhoven The Netherlands
Maasstad Ziekenhuis Stichting Rotterdam The Netherlands
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Meander Medical Center Amersfoort The Netherlands
Sint Franciscus Vlietland Groep Stichting Rotterdam The Netherlands
Deventer Ziekenhuis Deventer The Netherlands
Reinier de Graaf Groep Delft The Netherlands
Medical Center Haaglanden Leidschendam The Netherlands
Stichting Treant Ziekenhuiszorg Emmen The Netherlands
Zaans Medisch Centrum Stichting Zaandam The Netherlands
Bravis Ziekenhuis Roosendaal The Netherlands
Slingeland Ziekenhuis Doetinchem The Netherlands
Wilhelmina Ziekenhuis Assen Assen The Netherlands
Gelre Hospitals Zutphen The Netherlands
Dijklander Ziekenhuis Hoorn The Netherlands
Rzarxuxoo Zxcnbihhad Svcfcdyvg Arnhem The Netherlands
Uumxfgluxjbp Mkocdnp Cdczlug Gyjjfakfr Groningen The Netherlands
Snprlmzwb Meqnxyi Zocfwlhpxc Groningen The Netherlands
Mruylfapindmlr Pcyonal Bhed Beugen The Netherlands
Odhhsfyjou Zpedhkgqge Gnzjsamvw Bzvu Scheemda The Netherlands
Lllmrjbqru Zvwxkzsjrg Ryasdzqz Roermond The Netherlands
Byqjebt Zjwardyiti Gorinchem The Netherlands
Akteeguj Dk Rbxkpf Zmddlkmcce Bnyi Goes The Netherlands
Ibstnifqlh Ziplgrfosm Capelle Aan Den Ijssel The Netherlands
Sgqwnjf Geldrop The Netherlands
Agmrssuop Uiv Amsterdam The Netherlands
Emjxkmv Uusdxlsozqdp Mbbpsfr Cbcakvq Rxvulmtwd (hkidfru Mqd Rotterdam The Netherlands
Sch Eejywztjj Hqpawhlc Toufgij Tilburg The Netherlands
Sfh Jvtu Gaimpszr Woacv Weert The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
08.05.2024

Trial locations

Daratumumab is a medication used in the treatment of multiple myeloma. It works by targeting a specific protein on the surface of myeloma cells, helping the immune system to identify and destroy these cancerous cells.

Lenalidomide is a drug that helps to slow the growth of cancer cells and boosts the immune system to fight against multiple myeloma. It is often used in combination with other medications to enhance its effectiveness.

Dexamethasone is a type of steroid that reduces inflammation and helps to manage symptoms associated with multiple myeloma. It is commonly used alongside other treatments to improve patient outcomes.

Investigated diseases:

Multiple Myeloma – Multiple myeloma is a type of cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this disease, abnormal plasma cells multiply and accumulate in the bone marrow, leading to bone damage and affecting the production of normal blood cells. As the disease progresses, it can cause bone pain, fractures, anemia, and increased susceptibility to infections. The abnormal cells can also produce a protein that can damage the kidneys. Over time, the disease can lead to complications such as kidney dysfunction and weakened bones. The progression of multiple myeloma varies among individuals, with periods of stability and periods of active disease.

Trial ID:
2023-508586-33-00
NCT ID:
NCT06187441
Trial Phase:
Therapeutic confirmatory (Phase III)

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