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Study of Daratumumab, Pomalidomide, and Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying a condition called multiple myeloma, which is a type of cancer that affects plasma cells in the bone marrow. The study is specifically for patients whose disease has returned or has not responded to previous treatments. The trial will use a combination of medications: daratumumab, pomalidomide (also known as CC-4047), and dexamethasone. These medications are being tested together to see how effective they are in treating this form of multiple myeloma.

The purpose of the study is to evaluate the effectiveness of this combination of drugs. Participants will receive these medications over a period of time, with the treatment lasting up to 72 weeks. The medications will be given in different forms: daratumumab as an injection under the skin, pomalidomide as a capsule taken by mouth, and dexamethasone either as an injection or oral drops. Some participants may receive a placebo instead of one of the medications.

Throughout the study, participants will be monitored to see how their disease responds to the treatment. The study aims to determine if the combination of daratumumab, pomalidomide, and dexamethasone can help achieve a state where the disease is not detectable, known as minimal residual disease negativity. The trial will also look at other outcomes, such as how long patients live without the disease getting worse and the overall response to the treatment. Safety and any side effects will also be closely observed during the trial.

1 initial treatment phase

The treatment involves the administration of three medications: daratumumab, pomalidomide, and dexamethasone.

Daratumumab is given as a subcutaneous injection. The frequency and duration of administration will be determined by the healthcare provider based on individual response and tolerance.

Pomalidomide is taken orally in the form of hard capsules. The dosage may vary, with available strengths of 1 mg, 2 mg, 3 mg, and 4 mg. The specific dosage and schedule will be provided by the healthcare team.

Dexamethasone is administered either as an oral solution or through infusion. The dosage and frequency will be tailored to the patient’s needs.

2 monitoring and assessment

Regular monitoring will be conducted to assess the effectiveness of the treatment and to check for any side effects.

The primary goal is to achieve a state called molecular minimal residual disease (MRD) negativity, which indicates a very low level of cancer cells.

Assessments will include blood tests, imaging studies, and other evaluations as deemed necessary by the healthcare provider.

3 follow-up and evaluation

The treatment’s success will be evaluated based on several factors, including progression-free survival, overall response rate, and overall survival.

The duration of response and time to the next anti-myeloma therapy will also be considered.

Safety and any adverse effects will be closely monitored throughout the trial.

Who Can Join the Study?

  • The patient must have given voluntary written informed consent, meaning they agree to participate in the study after understanding what it involves.
  • The patient must have an ECOG Performance Status score of 0, 1, or 2. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 2 indicating some limitations.
  • The patient must meet certain laboratory values, including:
    • Platelet count of at least 50 x 109/L (or 30 x 109/L if more than 50% of the bone marrow is affected by myeloma) within 14 days before starting the drug.
    • Absolute neutrophil count (ANC) of at least 1 x 109/L without using growth factors. Neutrophils are a type of white blood cell important for fighting infections.
    • Corrected serum calcium level of 14 mg/dL (3.5 mmol/L) or less.
    • Alanine transaminase (ALT)</b) level of 3 times the upper limit of normal (ULN) or less. ALT is an enzyme that helps break down proteins and is measured to check liver health.
    • Total bilirubin level of 2 times the ULN or less. Bilirubin is a substance made during the normal breakdown of red blood cells.
    • Creatinine clearance of at least 15 mL/minute, which measures how well the kidneys are working.
  • Females of childbearing potential must follow a Pregnancy Prevention Plan and use effective contraception before, during, and after treatment. Males must use effective contraception if sexually active with females of childbearing potential and agree not to donate sperm for at least 3 months after the last dose of certain drugs.
  • The patient must be at least 18 years old.
  • The patient must have documented Multiple Myeloma (MM), a type of blood cancer.
  • The patient must have a specific genetic marker called del(17p) in at least 10% of bone marrow plasma cells at any time in their MM history. This is detected using a test called FISH.
  • The patient must have certain levels of monoclonal paraprotein (M-protein) in the blood or urine, or other specific protein levels related to MM.
  • The patient must have received at least 1 and no more than 3 previous treatments for MM.
  • The patient must have received at least 2 consecutive cycles of a drug called lenalidomide in a previous treatment.
  • The patient must have shown a response, such as partial remission (PR) or better, to at least one previous treatment.
  • The patient must have either refractory or relapsed and refractory disease, meaning the disease has progressed during or within 60 days of finishing their last myeloma treatment.

Who Cannot Join the Study?

  • Patients who have not been diagnosed with Multiple Myeloma that has come back or is not responding to treatment cannot participate. Multiple Myeloma is a type of cancer that affects certain blood cells.
  • Patients who are not within the specified age range for the study cannot participate. The age range is determined by the study organizers.
  • Patients who do not meet the gender requirements for the study cannot participate. The study is open to both male and female participants.
  • Patients who are considered part of a vulnerable population may not be eligible. Vulnerable populations include groups that may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Bari Italy

Other Sites

Site Name City Country Status
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Azienda Ospedaliera S Maria Di Terni Terni Italy
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Universita Degli Studi Di Brescia Brescia Italy
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Ajhknwp Oxecbsvhurq Uxximqtnrbbez Czmxioqshdwf Dbhhi Sprmnq E Dgibp Sxhkcxq Dr Tofuda Turin Italy
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
01.05.2019

Trial locations

Investigated drugs:

Daratumumab is a medication used in the treatment of 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.

Pomalidomide is a drug that helps to slow down or stop the growth of cancer cells in multiple myeloma. It also helps the immune system to attack the cancer cells more effectively.

Dexamethasone is a type of steroid medication that is used to reduce inflammation and suppress the immune system. In the context of multiple myeloma, it helps to enhance the effects of other cancer treatments.

Multiple Myeloma – Multiple Myeloma is a type of blood cancer that affects plasma cells, which are a type 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 symptoms such as bone pain, fatigue, and frequent infections due to weakened immune function. Over time, the accumulation of these abnormal cells can lead to complications like anemia, kidney problems, and increased calcium levels in the blood. The disease often goes through periods of remission and relapse, where symptoms may improve and then return.

Trial ID:
2023-506733-30-00
Protocol code:
DEDALO
NCT ID:
NCT04124497
Trial Phase:
Therapeutic exploratory (Phase II)

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