Study on the Safety and Tolerability of OsteoDex for Patients with Relapsed or Refractory Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying Multiple Myeloma, a type of cancer that affects plasma cells in the bone marrow. The treatment being tested is called OsteoDex, also known by its code name ODX. OsteoDex is a solution given through an infusion, which means it is administered directly into the bloodstream. The main goal of the study is to determine how safe and tolerable OsteoDex is for patients who have experienced a return or worsening of their multiple myeloma after previous treatments.

Participants in the study will receive OsteoDex and will be monitored over a period of 14 weeks. During this time, doctors will check for any side effects and changes in the patients’ health through regular physical exams, blood tests, and other assessments. The study will also look at how well the treatment works by measuring changes in specific proteins and markers in the blood that are related to multiple myeloma. Additionally, the study will assess the quality of life of participants using a standard questionnaire.

The study aims to provide valuable information about the safety and potential benefits of OsteoDex for people with multiple myeloma. By participating, patients will help researchers understand more about this treatment and its effects on the disease. The results of this study could lead to new treatment options for those affected by multiple myeloma in the future.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose, which is to determine the safety and tolerability of OsteoDex in individuals with relapsed or refractory multiple myeloma.

The patient will be required to sign an informed consent form, confirming their understanding and willingness to participate.

2 initial assessment

An initial assessment will be conducted to confirm eligibility based on specific criteria, including age, diagnosis, previous treatments, and current health status.

Laboratory tests will be performed to ensure the patient meets the necessary health requirements, such as adequate blood counts and organ function.

3 treatment phase

The patient will receive OsteoDex as a solution for infusion. The exact dosage and frequency will be determined by the study protocol and the patient’s specific needs.

The treatment phase will last for 14 weeks, during which the patient will receive regular infusions and attend scheduled visits for monitoring.

4 monitoring and follow-up

Throughout the treatment phase, the patient will undergo regular monitoring, including physical examinations, vital signs checks, and laboratory tests to assess safety and tolerability.

The patient’s response to treatment will be evaluated using specific criteria, and changes in certain biomarkers will be measured at various intervals.

5 quality of life assessment

The patient’s quality of life will be assessed using a standardized tool at the beginning of the study and at weeks 2, 8, and 14.

This assessment will help determine the impact of the treatment on the patient’s overall well-being.

6 end of study

At the end of the 14-week period, the patient will undergo a final evaluation to assess the overall response to the treatment and any changes in health status.

The study’s primary focus is on safety and tolerability, with secondary outcomes including response rate and quality of life improvements.

Who Can Join the Study?

The patient must be a male or female who is 18 years or older at the time of signing the consent form.
The patient must have a documented diagnosis of multiple myeloma according to specific medical guidelines.
The patient must have a measurable disease, which means certain levels of proteins in the blood or urine are present. This includes:
- Serum monoclonal paraprotein (M-protein) level of 0.5 g/dL or higher or urine M-protein level of 200 mg/24 hours or higher.
- For those with light chain multiple myeloma, a serum immunoglobulin free light chain (FLC) of 10 mg/dL or higher and an abnormal serum immunoglobulin kappa lambda FLC ratio.
The patient must have received 1-5 previous treatments that include specific types of medications, unless they were unable to take them due to health reasons.
The patient must show evidence of disease progression after their last treatment, based on specific medical criteria.
The patient must have a performance status of 0-2 on a scale that measures their ability to perform daily activities.
The patient must meet certain laboratory requirements:
- Neutrophils (a type of white blood cell) of 1.0 x 10⁹/l or higher.
- Hemoglobin (a protein in red blood cells) of 80 g/l or higher.
- Platelets (cells that help with blood clotting) of 50 x 10⁹/l or higher.
- Liver function: Total bilirubin of 1.5 times the upper limit of normal or less, and AST/ALT (liver enzymes) of 2.5 times the upper limit of normal or less.
- Kidney function: Creatinine of 1.5 times the upper limit of normal or less.
- Electrolytes: Sodium, potassium, calcium, phosphate, and magnesium must be within normal ranges. Supplements may be given to correct these values if needed.
The patient must not have had any other cancers in the past 5 years, except for certain types of skin cancer that have been successfully treated.
The patient must be able to follow the study schedule and meet other study requirements.

Who Cannot Join the Study?

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Karolinska University Hospital	Solna	Sweden
Scdwjtiqxvw Uawdrvkodf Hrqjozugjwubgku Gllgstywqfruipskb	Gothenburg	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not recruiting	01.01.2023

Trial locations

Investigated drugs:

Osteodex

ODX (OsteoDex) is a medication being studied for its safety and tolerability in patients with multiple myeloma, a type of blood cancer. The trial aims to understand how well patients can handle the medication and to observe any side effects that may occur.

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 crowd out healthy blood cells, leading to issues such as anemia, infections, and bone damage. As the disease progresses, it can cause bone pain, fractures, and high levels of calcium in the blood. Patients may also experience kidney problems due to the accumulation of abnormal proteins produced by the cancerous cells. Over time, the disease can lead to weakened bones and increased susceptibility to infections. The progression of Multiple Myeloma varies among individuals, with some experiencing slow development and others facing more rapid changes.

Trial ID:

2024-516969-36-00

Protocol code:

ODX-MM-001

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Tolerability of OsteoDex for Patients with Relapsed or Refractory Multiple Myeloma

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