#1 Clinical Trials Search in Europe

Study Comparing Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Patients with Untreated Multiple Myeloma Not Planning Stem Cell Transplant

3 1 1 1

What is this study about?

This clinical trial is focused on studying Multiple Myeloma, a type of cancer that affects plasma cells in the bone marrow. The study is comparing two treatment combinations for patients who have not yet received treatment for this condition and are not planning to undergo a stem cell transplant as their initial therapy. The first treatment combination includes Daratumumab, VELCADE (also known as Bortezomib), Lenalidomide, and Dexamethasone, referred to as D-VRd. The second combination includes VELCADE, Lenalidomide, and Dexamethasone, referred to as VRd. The purpose of the study is to determine if adding Daratumumab to the VRd combination improves the rate at which patients achieve a state called minimal residual disease (MRD) negativity, which means that no cancer cells can be detected in the bone marrow.

Participants in the study will receive one of the two treatment combinations. The study will monitor the participants over a period to see how well the treatments work in reducing the presence of cancer cells. The treatments involve taking medications in the form of capsules or injections. The study will also include a group of participants who will receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments. The study aims to provide valuable information on the effectiveness of these treatment combinations for patients with Multiple Myeloma.

The trial will continue until 2028, allowing researchers to gather comprehensive data on the long-term effects and benefits of the treatments. This study is important for understanding how to best treat Multiple Myeloma in patients who are not candidates for stem cell transplants. By participating in this study, researchers hope to improve treatment options and outcomes for individuals affected by this type of cancer.

1 initial treatment phase

The initial treatment phase involves the administration of several medications. The medications include Revlimid (lenalidomide) in various dosages, VELCADE (bortezomib), DARZALEX (daratumumab), and dexamethasone.

Revlimid is taken orally in capsule form. The dosages vary between 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg, depending on the specific treatment plan.

VELCADE is administered as a subcutaneous injection. The dosage is 3.5 mg.

DARZALEX is also given as a subcutaneous injection, with a dosage of 1800 mg.

Dexamethasone is taken orally in tablet form.

2 treatment schedule

The treatment schedule is structured in cycles. Each cycle typically lasts for a specified period, during which the medications are administered according to the protocol.

The frequency and duration of each medication depend on the cycle and the specific treatment plan. It is important to adhere to the schedule as prescribed.

3 monitoring and assessments

Throughout the trial, regular monitoring and assessments are conducted to evaluate the response to treatment.

These assessments may include blood tests, imaging studies, and other evaluations to monitor the condition and adjust treatment as necessary.

4 completion of treatment

Upon completion of the treatment cycles, a final assessment is conducted to determine the overall response to the treatment.

The primary objective is to achieve minimal residual disease (MRD) negativity, which indicates a significant reduction in disease presence.

Who Can Join the Study?

  • Must be newly diagnosed with Multiple Myeloma and not suitable for high-dose chemotherapy with stem cell transplantation. This could be due to being 65 years or older, having other health conditions that make chemotherapy risky, or choosing not to have chemotherapy.
  • Must have a confirmed diagnosis of Multiple Myeloma. This means having a certain number of abnormal plasma cells in the bone marrow or meeting specific criteria related to calcium levels, kidney function, anemia, or bone damage.
  • Must have a measurable disease, which means certain proteins related to Multiple Myeloma can be detected in the blood or urine.
  • Must have an ECOG performance status score of 0, 1, or 2. This is a scale that measures how well a person can perform daily activities.
  • Must have specific laboratory test results, such as certain levels of hemoglobin, neutrophils, platelets, liver enzymes, bilirubin, kidney function, and calcium.
  • Female participants who can have children must agree to use two reliable methods of birth control or abstain from heterosexual intercourse during the study and for three months after the last dose of treatment.
  • Female participants must have two negative pregnancy tests before starting the study.
  • Female participants must agree not to donate eggs for assisted reproduction during the study and for three months after the last dose of treatment.
  • Male participants must agree not to donate sperm during the study and for three months after the last dose of treatment.
  • Male participants who are sexually active with females who can have children must always use a latex or synthetic condom during the study and for three months after stopping the treatment.
  • Must sign an informed consent form, indicating understanding of the study and willingness to participate.
  • Must be able to follow the rules and restrictions of the study.

Who Cannot Join the Study?

  • Patients with any other active cancer besides Multiple Myeloma cannot participate.
  • Patients who have had a heart attack or severe heart problems in the past 6 months are excluded.
  • Patients with uncontrolled high blood pressure are not eligible.
  • Patients with severe kidney disease or those on dialysis cannot join the study.
  • Patients with severe liver disease are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with active infections that require treatment are not eligible.
  • Patients who have received another investigational drug within the last 30 days are excluded.
  • Patients with known allergies to the study drugs cannot participate.
  • Patients with a history of drug or alcohol abuse in the past year are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oncopole Claudius Regaud Toulouse France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France

Other Sites

Site Name City Country Status
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich Chorzow Poland
Hospital Del Mar Barcelona Spain
Instytut Hematologii I Transfuzjologii Warsaw Poland
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli Lublin Poland
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Brzozow Poland
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o. Slupsk Poland
Fakultni Nemocnice Plzen Plzen Czechia
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
Fundacio Assistencial De Mutua De Terrassa Fpc Terrassa Spain
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Hopital Beaujon Clichy France
University Hospital Ostrava Ostrava Czechia
Ajbzjnggr Utx Amsterdam The Netherlands
Nrwzeiqe Iefdqqsv Oqqzkgooz Izo Mnecr Srzcmmdbiemmlqcycdkbivhyzlff Iqviilue Bcsxeulf Cracow Poland
Uqbxuhhelwsdxi Celrrqb Kgnkpyoqd Gdansk Poland
Igbzfhnd Piiteuvvwbmtkse Cdohrg Cvmwob Marseille France

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

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
11.12.2018
France France
Not recruiting
11.12.2018
Germany Germany
Not recruiting
11.12.2018
Poland Poland
Not recruiting
11.12.2018
Spain Spain
Not recruiting
11.12.2018
The Netherlands The Netherlands
Not recruiting
11.12.2018

Trial locations

Investigated drugs:

Daratumumab is a medication used in this study to treat multiple myeloma, a type of blood cancer. It works by targeting a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells. In this trial, it is being tested to see if adding it to the standard treatment can improve outcomes for patients.

VELCADE (bortezomib) is a medication that helps treat multiple myeloma by interfering with the growth of cancer cells. It is part of the standard treatment regimen in this study and is used to help control the disease and improve patient outcomes.

Lenalidomide is a medication that modifies the immune system and has anti-cancer effects. It is commonly used in the treatment of multiple myeloma and is part of the standard treatment regimen in this study. It helps to slow down or stop the growth of cancer cells.

Dexamethasone is a type of steroid medication that is used to reduce inflammation and suppress the immune system. In the context of multiple myeloma treatment, it helps to enhance the effects of other cancer medications and manage symptoms associated with the disease.

Multiple Myeloma – Multiple Myeloma is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this disease, cancerous plasma cells multiply and crowd out healthy blood cells, leading to problems such as anemia, infections, and bone damage. As the disease progresses, it can cause bone pain, fractures, and high levels of calcium in the blood. The abnormal plasma cells can also produce a protein that can damage the kidneys. Over time, the disease can lead to weakened bones and increased risk of infections.

Trial ID:
2023-507312-13-00
Protocol code:
54767414MMY3019
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A study of etentamig and daratumumab compared to daratumumab, lenalidomide, and dexamethasone in adults with newly diagnosed multiple myeloma not eligible for transplant

    Recruiting

    4 1 1 1
    Investigated drugs:
    France Norway Spain

  • A study testing etentamig alone or with drug combinations in adult patients with multiple myeloma to assess safety and changes in disease activity

    Recruiting

    1 1 1 1
    Investigated drugs:
    Norway