Study on the Safety and Effectiveness of AZD0305 Alone and with Other Cancer Drugs for Adults with Relapsed or Refractory Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Multiple Myeloma, which is a condition where cancer cells form in the bone marrow and affect the blood. The study is specifically looking at cases where the disease has returned after treatment or has not responded to previous treatments, known as relapsed or refractory Multiple Myeloma. The treatment being tested in this study is a new medication called AZD0305, which is given as a solution through a vein, a method known as intravenous infusion. The study will explore how safe and tolerable AZD0305 is when used alone and in combination with other cancer treatments.

The purpose of the study is to determine the best dose of AZD0305 for future research and to see how well it works in treating relapsed or refractory Multiple Myeloma. Participants in the study will receive AZD0305, and some may also receive other cancer treatments alongside it. The study will monitor participants for any side effects and how their bodies respond to the treatment. This includes looking at how the drug moves through the body and how the immune system reacts to it.

Throughout the study, researchers will collect information on the safety of AZD0305 and its effects on the cancer. This will help determine if AZD0305 can be a potential treatment option for people with relapsed or refractory Multiple Myeloma. The study aims to provide valuable insights into the effectiveness of AZD0305 and its role in cancer treatment.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, performance status, and previous treatments for multiple myeloma.

Participants must have received at least three prior lines of treatment, including a proteasome inhibitor, an immunomodulator, and an anti-CD38 antibody.

2 initial assessment

An initial assessment is conducted to evaluate organ and bone marrow function. This includes tests for hematological, hepatic, and renal parameters.

3 treatment phase

The treatment involves the administration of AZD0305, a solution for infusion, given intravenously.

The dosage and frequency are determined during the study to assess safety and tolerability.

4 monitoring and evaluation

Participants are monitored for any dose-limiting toxicities and the incidence and severity of adverse events.

The study also evaluates the preliminary effectiveness of AZD0305 using specific response criteria.

5 follow-up

Regular follow-up visits are scheduled to assess the long-term effects and any development of anti-drug antibodies.

The study aims to determine the recommended dose for future phases based on the collected data.

Who Can Join the Study?

Participants must be at least 18 years old or the legal age of consent in the area where the study is conducted.
Participants should have an Eastern Cooperative Oncology Group performance status of 2 or less. This is a scale that measures how well a person can perform daily activities.
Participants must have documentation of Multiple Myeloma according to specific diagnostic criteria. This means the diagnosis should be confirmed based on established guidelines.
Participants must have one or more measurable disease criteria, such as a Serum M-protein level of 0.5 g/dL or higher. M-protein is a marker found in the blood.
Participants must have one or more measurable disease criteria, such as a Urine M-protein level of 200 mg/24h or higher. This is a marker found in the urine.
Participants must have one or more measurable disease criteria, such as a Serum immunoglobulin free light chain level of 10 mg/dL or higher, with an abnormal ratio of specific proteins in the blood.
Participants must have adequate organ and bone marrow function, which will be assessed during screening. This involves checking the health of blood, liver, and kidneys.
Participants must have received at least 3 prior lines of treatment, including a proteasome inhibitor (like bortezomib), an immunomodulator (like lenalidomide), and an anti-CD38 antibody (like daratumumab). These are types of medications used in previous treatments.

Who Cannot Join the Study?

Patients who have not experienced a return or worsening of their Multiple Myeloma condition. Multiple Myeloma is a type of cancer that affects certain cells in the bone marrow.
Patients who are not able to safely tolerate the study medication or its combination with other cancer treatments.
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 male or female, as both genders are included in the study.
Patients who are considered part of a vulnerable population, which means they might 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
Hospital Universitario De Salamanca	Salamanca	Spain
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Centre Hospitalier Universitaire De Lille	Lille	France
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Klinikum Nuernberg	Nürnberg	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Ucfgepclml Mzfpgzo Cdzhur Hdzohwjqfmpgxzyyh	Hamburg	Germany
Uccjxdoyktxqndmbhulvz Ejvgs Akh	Essen	Germany
Ujtcgfbpnxpgukosbhsyv Wdfqgxfbi Afo	Wuerzburg	Germany
Hmigcnga Uwoecimhwtigz Hmxwzkpp Tupis y Pqjqlw Iqjbaukf Csbaoe dfbhvxruxnrazhdit (gtdq	Badalona	Spain

Trial status

Country	Status	Recruitment Start
France	Recruiting	28.05.2024
Germany	Recruiting	28.05.2024
Spain	Recruiting	28.05.2024

Trial locations

Investigated drugs:

AZD0305 is an investigational medication being studied for its potential to treat relapsed or refractory multiple myeloma. It is being tested to understand how safe and tolerable it is for patients, as well as to determine the best dose to use in future studies. This medication is being evaluated both on its own and in combination with other cancer treatments to see how it might help in managing this type of cancer.

Relapsed or Refractory Multiple Myeloma – This 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 condition, the cancer has returned after treatment (relapsed) or has not responded to treatment (refractory). It typically progresses by causing an overproduction of abnormal plasma cells, leading to bone damage, kidney problems, and a weakened immune system. Patients may experience symptoms such as bone pain, fatigue, and frequent infections. The disease can lead to complications like anemia and high calcium levels in the blood. It is a chronic condition that requires ongoing management to control symptoms and slow progression.

Trial ID:

2023-508590-89-00

Protocol code:

D7230C00001

NCT ID:

NCT06106945

Trial Phase:

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

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Study on the Safety and Effectiveness of AZD0305 Alone and with Other Cancer Drugs for Adults with Relapsed or Refractory Multiple Myeloma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?