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Study on the Safety and Effectiveness of HDP-101 for Patients with Relapsed or Refractory 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 is focused on studying a group of diseases known as plasma cell disorders, with a particular emphasis on 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. The study is testing a new treatment called HDP-101, which is given as a solution for injection directly into the bloodstream.

The purpose of the study is to evaluate the safety and effectiveness of HDP-101 in patients who have experienced a return of their disease or whose disease has not responded to previous treatments. The study is divided into two phases. In the first phase, researchers aim to determine the highest dose of HDP-101 that patients can tolerate. In the second phase, the focus is on assessing how well the treatment works in managing the disease.

Participants in the study will receive HDP-101 and will be monitored closely by the research team. Some participants may receive a placebo, which is a substance with no active medication. The study will involve regular visits to the clinic for treatment and follow-up assessments to monitor the participants' health and the effects of the treatment. The study is expected to continue until 2026, providing valuable information on the potential benefits and risks of HDP-101 for patients with Multiple Myeloma.

The research process

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

  1. Step 1

    Initial treatment phase

    The study begins with the administration of the medication HDP-101, which is a solution for injection. This medication is given through an intravenous route, meaning it is delivered directly into the bloodstream.

    The primary goal during this phase is to determine the maximum dose that can be tolerated without causing significant side effects. This is known as the maximum tolerable dose (MTD).

  2. Step 2

    Dose determination

    The focus is on identifying the appropriate dose for further study. This involves monitoring for any dose-limiting toxicities, which are side effects that prevent further dose increases.

    Patients are closely observed to ensure safety and to adjust the dosage as needed.

  3. Step 3

    Efficacy assessment

    Once the appropriate dose is determined, the study progresses to assess the effectiveness of HDP-101 in treating the condition.

    The objective response rate (ORR) is measured, which indicates the proportion of patients who experience a significant reduction in disease symptoms.

  4. Step 4

    Ongoing monitoring

    Throughout the study, patients continue to receive HDP-101 and are monitored for any changes in their condition.

    Regular assessments are conducted to evaluate both the safety and effectiveness of the treatment.

  5. Step 5

    Study completion

    The study is expected to conclude by May 26, 2026. At this point, all data collected will be analyzed to determine the overall outcomes of the treatment.

    Patients will receive follow-up care as needed based on their individual health status and the results of the study.

Who can join the trial?

18 criteria

  • Patients must sign an informed consent form and agree to follow the study's rules and restrictions.
  • Patients need to have proper functioning of their organs, which includes:
    • Enough white blood cells (absolute neutrophil count) and platelets without recent transfusions.
    • Hemoglobin levels above a certain threshold without recent red blood cell transfusions.
    • Normal blood clotting times.
    • Proper kidney function, measured by creatinine clearance.
    • Low levels of protein in urine.
    • Normal levels of bilirubin in the blood, which is a substance made by the liver.
    • Normal levels of liver enzymes (aspartate and alanine transaminases).
    • Female patients must either be unable to have children or, if they can have children, must have a negative pregnancy test and use reliable birth control methods during the study and for 4 months after the last treatment.
    • Male patients must have had a vasectomy or agree to use effective birth control methods during the study and for 3 months after the last treatment.
    • Patients must be 18 years or older.
    • Patients should have a life expectancy of more than 12 weeks, as judged by the study doctor.
    • Patients must have an ECOG Performance Status of 0 to 2, which measures their ability to perform daily activities.
    • Patients must have a confirmed diagnosis of active **Multiple Myeloma** according to specific criteria.
    • Patients must have had a stem cell transplant or be considered ineligible for one.
    • Patients must have received previous treatments for **Multiple Myeloma**, including specific types of drugs, and must have either not responded to the last treatment, relapsed, or stopped due to side effects.
    • For Phase 1, patients with certain types of **Multiple Myeloma** that do not meet specific measurement criteria are eligible. For Phase 2a, patients must have measurable disease based on specific protein levels in blood or urine.
    • Any side effects from previous treatments must have improved to a mild level, except for hair loss and mild nerve damage.

Who cannot join the trial?

5 criteria

  • Patients who have not been diagnosed with relapsed or refractory Multiple Myeloma (r/r MM). This means the disease has either returned after treatment or did not respond to treatment.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial group.
  • Patients who are not able to provide informed consent or are part of a vulnerable population that cannot participate in the study.
  • Patients who are not able to follow the study procedures or comply with the study requirements.
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Investigated drugs

HDP-101 is an experimental medication being studied for its safety, tolerability, and effectiveness in treating patients with plasma cell disorders, including multiple myeloma. The trial aims to find the best dose of this medication for patients whose multiple myeloma has returned or is not responding to other treatments.

What is already known about the treatment

HDP-101 – This medication is administered intravenously and is currently being studied in clinical trials for its safety, tolerability, and effectiveness in treating relapsed or refractory multiple myeloma. It is in the early stages of research, specifically Phase 1/2a trials, and is not yet widely recognized in medical literature. The main therapeutic indication for HDP-101 is for patients with plasma cell disorders, particularly multiple myeloma that has not responded to previous treatments. At the molecular level, HDP-101 works by targeting specific proteins on cancer cells, disrupting their growth and survival. It is classified pharmacologically as an investigational drug, focusing on targeted cancer therapy.

Investigated diseases

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 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, frequent infections, anemia, and kidney problems. The condition is characterized by periods of remission and relapse, where symptoms may improve and then return. Over time, the disease can become refractory, meaning it no longer responds to standard treatments.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-515273-10-00Protocol codeHDP-101-01Estimated enrolment98 patientsSponsorHeidelberg Pharma AG

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