Study on the Safety and Effectiveness of HDP-101 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 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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country
Asklepios Kliniken Hamburg GmbH	Hamburg	Germany
Orszagos Onkologiai Intezet	Budapest	Hungary
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
Pratia Hematologia Sp. z o.o.	Katowice	Poland
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Semmelweis University	Budapest	Hungary
Pratia S.A.	Skorzewo	Poland
University Of Pecs	Pecs	Hungary
Hospital General Universitario Morales Meseguer	Murcia	Spain
Servei De Salut De Les Illes Balears	Palma	Spain
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Wjrjnetxuww Wofqptgivuclesdxnmla Cxepbpe Oihbpectq I Tesivsxgvjhfu Ii Mbbimxesdqs W Lzutj	Lodz	Poland
Slxuvld Wvhvluacgi W Otuql Shy z ooqd	Opole	Poland
Mislhwfpv Ixlhtkphyo Ctuzgwga Sbkghcfr Sqn z ojil	Warsaw	Poland
Afurpjq Snn z ousd	Poznan	Poland
Hfkgqaxf Upapnyyuaetbd Dx Lh Pyizsima	Madrid	Spain
Agqixhg Ckmexin Styxeq	Bucharest	Romania

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	21.02.2022
Hungary	Recruiting	21.02.2022
Poland	Recruiting	21.02.2022
Romania	Recruiting	21.02.2022
Spain	Not yet recruiting	21.02.2022

Trial locations

Investigated drugs:

Hdp-101

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.

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 ID:

2024-515273-10-00

Protocol code:

HDP-101-01

NCT ID:

NCT04879043

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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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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