Not recruitingRare disease

Comparing CT-P44 and Darzalex Faspro with lenalidomide and dexamethasone in patients with refractory or relapsed multiple myeloma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on treating patients with Refractory or Relapsed Multiple Myeloma, a type of blood cancer that returns after previous treatment or does not respond to current treatments. The study compares two medications: CT-P44 and Darzalex Faspro, both containing the active substance daratumumab. These medications will be used in combination with two other drugs: lenalidomide and dexamethasone.

The purpose of this study is to compare how well CT-P44 works compared to Darzalex Faspro, and how the body processes these medications. Both medications are given through subcutaneous injection, which means they are injected under the skin. The study is designed as a double-blind trial, meaning neither the patients nor the healthcare providers know which medication is being given.

During the study, participants will receive treatment for up to 104 weeks. The medications will be administered regularly according to a specific schedule, with a maximum daily dose of 1800 mg. Patients will be monitored throughout the treatment period to evaluate how well the medications work and to check for any side effects.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
You will receive a combination of medications through subcutaneous injection (injection under the skin) and other medications
The treatment combines daratumumab with two additional medications: lenalidomide and dexamethasone
The treatment will be administered in cycles, with regular monitoring of your response
Step 2
First dose evaluation
During the first week of treatment, your body's response to the medication will be closely monitored
Medical tests will be performed to measure how your body processes the medication
Step 3
Ongoing treatment phase
You will continue receiving treatment for up to 9 doses
Between weeks 8 and 10, additional tests will be conducted to measure how your body processes the medication
Your response to the treatment will be evaluated regularly throughout this period
Step 4
24-week assessment
Your overall response to the treatment will be evaluated up to week 24
The medical team will assess the effectiveness of the treatment based on standard criteria for multiple myeloma
This assessment will determine how well you have responded to the treatment
Step 5
Extended monitoring
The study will continue with regular monitoring of your condition
The total duration of the study extends until October 31, 2029
Regular assessments will continue throughout this period to monitor your health status

Who can join the trial?

7 criteria

Must be 18 years of age or older
Must have been diagnosed with multiple myeloma (a type of blood cancer that affects plasma cells)
Must have relapsed or refractory disease (meaning the cancer has returned after treatment or did not respond well to previous treatments)
Must have shown a positive response (partial response or better) to at least one previous treatment according to established medical criteria
Must have experienced disease progression (worsening of the condition) during or after their most recent treatment
Must have received at least 1 but no more than 3 previous treatments for multiple myeloma
Both men and women can participate in the study

Who cannot join the trial?

14 criteria

Prior treatment with daratumumab (a type of targeted therapy for multiple myeloma) or other anti-CD38 medications
Active plasma cell leukemia (an aggressive form of blood cancer)
History of severe allergic reactions to similar medications
Active infections requiring treatment, including hepatitis B, hepatitis C, or HIV
Major surgery within 2 weeks before starting the study
Participation in other clinical trials within 4 weeks before this study
Significant heart problems, including heart failure or recent heart attack
Severe liver or kidney problems
Active or untreated cancer other than multiple myeloma
Pregnancy or breastfeeding
Unable to use effective birth control methods during the study
Mental conditions that could interfere with following study procedures
Stem cell transplant (a procedure to replace damaged bone marrow) within 100 days before the study
Use of other experimental treatments within 4 weeks before the study

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Institut Catala D'oncologia
L'hospitalet De Llobregat, Spain
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Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Cracow, Poland
Verified
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu
Torun, Poland

Trial locations

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Investigated drugs

CT-P44
is an investigational medication being tested as a biosimilar to Darzalex Faspro. It is designed to treat patients with multiple myeloma, a type of blood cancer. It is given as an injection under the skin (subcutaneous injection).
Darzalex Faspro
(daratumumab) is an approved medication used to treat multiple myeloma. It works by targeting specific proteins on cancer cells to help the immune system fight the cancer. It is administered as an injection under the skin.
Lenalidomide
is a medication that helps fight multiple myeloma by working in several ways. It helps boost the immune system, blocks the growth of cancer cells, and prevents the formation of new blood vessels that feed the cancer.
Dexamethasone
is a corticosteroid medication that helps reduce inflammation in the body. In multiple myeloma treatment, it is often used in combination with other medications to make them work more effectively and help manage certain side effects.

What is already known about the treatment

CT-P44
A subcutaneous medication being investigated as a biosimilar to Darzalex Faspro for treating refractory or relapsed multiple myeloma, administered through injection under the skin in combination with lenalidomide and dexamethasone. This drug is currently in Phase 1/3 clinical trials to evaluate its pharmacokinetic similarity and therapeutic equivalence to the reference product, with the primary focus on achieving very good partial response or better in patients. The medication belongs to the class of targeted immunotherapy drugs designed to treat multiple myeloma.
Darzalex Faspro
A subcutaneous formulation of daratumumab that is approved for treating multiple myeloma, administered through injection under the skin in combination with other medications. This medication works by targeting a specific protein called CD38 on the surface of myeloma cells, helping the immune system to identify and destroy cancer cells. It belongs to the class of monoclonal antibodies and represents a significant advancement in multiple myeloma treatment by offering a more convenient administration method compared to intravenous alternatives.
Lenalidomide
An oral immunomodulatory drug used in combination therapy for multiple myeloma, taken as a capsule by mouth. This medication works by helping to strengthen the immune system's response against cancer cells while also directly interfering with cancer cell growth. It belongs to the class of immunomodulatory drugs and is commonly used in various combination treatments for multiple myeloma.
Dexamethasone
An oral corticosteroid medication that is commonly used as part of combination therapy in multiple myeloma treatment, typically taken as a tablet. This synthetic steroid helps reduce inflammation and suppress immune system activity, which can enhance the effectiveness of other anti-myeloma treatments while also helping to manage symptoms. It belongs to the glucocorticoid class of medications and is widely used in various cancer treatment protocols.

Investigated diseases

Multiple Myeloma - A type of blood cancer that develops in plasma cells, which are white blood cells that normally produce antibodies to fight infections. In this condition, abnormal plasma cells multiply uncontrollably in the bone marrow, forming tumors in multiple bones throughout the body. These cancerous cells produce large amounts of abnormal proteins while crowding out healthy blood cells. The disease can weaken bones, reduce immune function, and interfere with the production of normal blood cells. Multiple myeloma typically progresses through cycles of active disease and remission.