Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Phase I/IIa Study of ODX (OsteoDex) in Multiple Myeloma

This research is a study looking at a new medicine called OsteoDex for people with multiple myeloma. We are in the early stages (Phase I and IIa) of testing this drug. Our main goal is to find out if OsteoDex is safe and what side effects it might cause. We'll be carefully watching participants and doing tests like blood samples and physical checks to make sure the treatment is well-tolerated. Beyond safety, we'll also be looking at whether OsteoDex helps in treating the cancer, for example, by seeing if the amount of cancer in the body reduces. We'll also check how people's quality of life changes during the study. This study is open to adults of all ages and genders who have multiple myeloma.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Dextech Medical AB

Enrolment target

Start

16 Sep 2024

Multiple Myeloma

What is this study about?

This study is designed to explore a new potential treatment called OsteoDex for a type of cancer called multiple myeloma. Multiple myeloma affects important cells in your bone marrow. When researchers discover a new medicine, they need to test it very carefully, step by step, to make sure it's safe and effective.

This particular study is in an early stage, which we call Phase I and Phase IIa. In these early phases, the most important thing is to make sure the treatment isn't harmful and that people can tolerate it. The researchers will be looking very closely at any side effects people might experience, checking vital signs like blood pressure and heart rate, and doing various medical tests. This careful monitoring helps them understand the drug's safety profile before it can be tested in larger groups of people.

While safety is the main focus, the study will also look for early signs that OsteoDex might be helping to treat the multiple myeloma. This includes checking how the cancer responds to the treatment and seeing if people's quality of life improves. The information gathered from this study will be crucial in deciding if OsteoDex should move forward to later, larger studies.

Key takeaways

This study is testing a new drug called OsteoDex for multiple myeloma.
The main aim is to check if OsteoDex is safe and well-tolerated.
Researchers will also look for early signs if the treatment helps the cancer.
The study includes adults aged 18 and over, with multiple myeloma.
Participation involves regular clinic visits, blood tests, and health checks for 14 weeks.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. The study is open to both men and women. You must have a diagnosis of multiple myeloma to be considered.

There might be other health conditions or medications that could prevent someone from joining. These detailed criteria help the research team ensure the safety of everyone taking part and make sure the study results are clear and reliable. The study team will review your medical history carefully to confirm if this study is suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of multiple myeloma?
Are you able to attend regular clinic appointments?
Are you comfortable with blood tests and physical examinations?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the new treatment called OsteoDex. The study will involve regular visits to the clinic over a period of 14 weeks. During these visits, the research team will perform several assessments to monitor your health and how you are responding to the treatment.

These assessments will include physical examinations, measuring your vital signs (such as blood pressure and heart rate), taking blood samples for various tests, collecting urine samples, and performing heart checks (ECGs). You will also be asked to complete questionnaires about your quality of life. After the 14-week treatment period, there will be follow-up checks to continue monitoring your health. The total duration of your active participation in the treatment part of the study will be at least 14 weeks.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new treatment that isn't yet widely available, which might help your condition. However, there's no guarantee the treatment will work for you, and like all medicines, OsteoDex might cause side effects, some of which could be serious or unexpected. The research team will monitor you closely to identify and manage any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that develops from plasma cells. These are white blood cells found mainly in your bone marrow.

What does 'Phase I/IIa' mean in a clinical trial?

These are early stages of testing a new medicine. Phase I mainly checks if a drug is safe and finds the right dose. Phase IIa then looks more closely at its effectiveness and continues to check for safety in a larger group.

What is OsteoDex?

OsteoDex is the name of the new investigational drug being tested in this study. It's a potential new treatment for multiple myeloma.

Will I know if the treatment is helping me during the study?

The research team will share relevant information about your tests and condition with you as the study progresses, but they cannot guarantee specific outcomes or predict how you will respond.

How long will I need to be in the study?

The main treatment and assessment period will last for 14 weeks. There might be some follow-up appointments after this.