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Study of IDP-121 for Patients with Relapsed or Refractory Multiple Myeloma, B-cell Lymphoma, or Chronic Lymphocytic Leukemia

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What is this trial about?

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

This clinical trial is focused on studying certain blood-related cancers, specifically Chronic Lymphocytic Leukemia (CLL), B-cell lymphomas, and Multiple Myeloma (MM). The treatment being tested is a new medication called IDP-121, which is given as an infusion directly into the bloodstream. The purpose of the study is to find the best dose of IDP-121 that patients can tolerate and to see how well it works in treating these cancers.

The study is divided into two phases. In the first phase, different doses of IDP-121 will be given to patients to determine the highest dose that can be safely administered. This is known as the dose-escalation phase. In the second phase, the study will focus on how effective the recommended dose is in treating the cancers. This phase will look at how many patients respond to the treatment and how long the response lasts.

Throughout the study, patients will receive regular check-ups to monitor their health and the effects of the treatment. This includes checking vital signs, conducting physical exams, and performing various tests like blood tests and heart monitoring. The study aims to gather information on how the treatment affects the body and how long patients can live without the cancer getting worse. Safety and any side effects will also be closely observed to ensure the well-being of the participants.

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
Joining the study
Upon joining the study, the patient will have already met the necessary criteria, including age, health status, and specific medical conditions such as chronic lymphocytic leukemia, B-cell lymphomas, or multiple myeloma.
The patient will have provided informed consent, understanding that participation is voluntary and can be withdrawn at any time.
Step 2
Dose-escalation phase (phase 1)
The patient will receive IDP-121, a concentrate for solution for infusion, administered intravenously.
The purpose of this phase is to determine the maximum tolerated dose and the recommended dose for the next phase.
The patient will be monitored for any dose-limiting toxicities over a 28-day cycle.
Step 3
Expansion phase (phase 2)
In this phase, the patient will continue to receive IDP-121 at the recommended dose determined in phase 1.
The focus will be on evaluating the overall response rate to the treatment.
The patient will be observed for any changes in their condition and response to the medication.
Step 4
Monitoring and assessments
Throughout the trial, the patient will undergo regular assessments, including vital signs, physical examinations, and laboratory tests such as hematology and biochemistry.
Electrocardiograms (ECG) will be performed to monitor heart function.
The patient will be evaluated for any adverse effects or serious adverse effects related to the treatment.
Step 5
End of trial
The trial is estimated to conclude by December 31, 2025.
Upon completion, the patient's overall response to the treatment, progression-free survival, and overall survival will be assessed.
The patient will receive information about their participation and any follow-up care required.

Who can join the trial?

14 criteria

Must be at least 18 years old.
Must have a **performance status** of 2 or less. This means you should be able to carry out all self-care but unable to carry out any work activities.
Must have a **life expectancy** of at least 3 months.
Must be willing and able to follow the study's rules and requirements, according to the investigator's opinion.
Must provide written consent to participate in the study, understanding that you can withdraw at any time without affecting your future medical care.
Must have been diagnosed with **chronic lymphocytic leukemia (CLL)**, **B-cell lymphomas**, or **multiple myeloma (MM)** and be ineligible for available treatments.
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Must have adequate **blood and biochemical levels**, including:
- **Hemoglobin** level greater than 8.0 g/dl without needing a blood transfusion in the past 7 days.
- **Platelet count** greater than 75 x 10⁹/L without needing a transfusion in the past 7 days. If your bone marrow is affected, the count can be 50 x 10⁹/L or more.
- **Absolute neutrophil count (ANC)** greater than 0.75 x 10⁹/L without needing support from a medication called G-CSF in the past 7 days.
- **Aspartate transaminase (AST)** level less than 2.5 times the upper limit of normal if you don't have liver metastases, or less than 5 times if you do.
- **Alanine transaminase (ALT)** level less than 2.5 times the upper limit of normal if you don't have liver metastases, or less than 5 times if you do.
- **Total bilirubin** level less than 2 times the upper limit of normal.
- **Creatinine clearance** greater than 30 mL/min, which is a measure of kidney function.
- Must have a **left ventricular ejection fraction** greater than 50% or above the lower limit of normal for the institution, as determined by an echocardiogram. This measures how well your heart pumps blood.

Who cannot join the trial?

10 criteria

Patients with other types of cancer not specified in the study.
Patients who have had a recent heart attack or severe heart problems.
Patients with uncontrolled high blood pressure.
Patients with severe liver or kidney disease.
Patients who are pregnant or breastfeeding.
Patients who have had an organ transplant.
Patients with active infections that require treatment.
Patients who are currently participating in another clinical trial.
Patients with a history of allergic reactions to similar medications.
Patients with any condition that the study doctors believe would make it unsafe to participate.

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Verified sites

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

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Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
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Hospital Universitario 12 De Octubre
Madrid, Spain
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Hospital Universitario De Salamanca
Salamanca, Spain

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Investigated drugs

IDP-121 is an investigational medication being studied for its potential to treat certain blood cancers, including multiple myeloma, B-cell lymphoma, and chronic lymphocytic leukemia. The study aims to find the highest dose of IDP-121 that patients can tolerate without severe side effects and to determine the most effective dose for further testing. The medication is being tested to see how well it works in shrinking or controlling these types of cancer.

IDP-121

What is already known about the treatment

IDP-121 – IDP-121 is an investigational medication currently being studied in a clinical trial for its potential use in treating certain blood cancers, including chronic lymphocytic leukemia, B-cell lymphomas, and multiple myeloma. It is administered intravenously, allowing the medication to directly enter the bloodstream. The trial aims to determine the optimal dose and assess the response rate in patients. IDP-121 is believed to work by targeting specific pathways involved in the growth and survival of cancer cells, although its exact mechanism at the molecular level is still under investigation. It falls under the pharmacological classification of targeted cancer therapies, which are designed to interfere with specific molecules involved in tumor growth and progression.

Investigated diseases

Chronic Lymphocytic Leukemia (CLL)
This is a type of cancer that affects the blood and bone marrow, characterized by the production of too many abnormal lymphocytes, a type of white blood cell. Over time, these abnormal cells can crowd out healthy blood cells, leading to symptoms such as fatigue, infections, and swollen lymph nodes. The disease often progresses slowly, and many people may not experience symptoms for years. As it advances, it can affect the body's ability to fight infections and may lead to anemia or bleeding problems.
B-cell Lymphomas
These are a group of blood cancers that originate in B lymphocytes, which are a type of white blood cell responsible for producing antibodies. B-cell lymphomas can vary widely in their behavior, from slow-growing forms to more aggressive types. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The progression of the disease depends on the specific type of B-cell lymphoma, with some forms remaining stable for years and others requiring immediate treatment.
Multiple Myeloma (MM)
This is a cancer of plasma cells, which are a type of white blood cell found in the bone marrow. In multiple myeloma, cancerous plasma cells multiply and produce abnormal proteins that can cause damage to bones and kidneys. The disease often leads to bone pain, fractures, anemia, and increased risk of infections. It typically progresses in stages, with periods of stability followed by more active phases where symptoms worsen.