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Study on Heparin Sodium and Sodium Chloride for Patients with Lymphoma or Myeloma Undergoing Stem Cell Collection

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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 two types of blood cancers: lymphoma and myeloma. The trial will explore the use of a medication called Heparin, which is a solution for injection, to see if it can help improve the collection of stem cells from the blood. Stem cells are special cells that can develop into different types of blood cells, and collecting them is an important step in certain treatments for these cancers. The trial will also use a solution called Sodium Chloride, which is commonly used in medical settings to help deliver medications through the veins.

The purpose of the study is to determine if a single dose of Heparin given before collecting stem cells can increase the number of stem cells collected. Participants in the study will receive either Heparin or a placebo before their stem cell collection. The study will monitor the number of stem cells collected and assess the safety of using Heparin in this way. The trial will involve regular blood tests to track the increase of stem cells in the blood during the collection process.

The study will also evaluate any potential side effects related to the use of Heparin, such as bleeding complications. This will be done by reviewing medical records after the stem cell collection is completed. Additionally, some of the collected stem cells will be analyzed using advanced techniques to better understand their characteristics. The trial aims to provide valuable information that could improve the process of stem cell collection for patients with lymphoma and 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.

Step 1
Joining the trial
Upon joining the trial, the patient is confirmed to have been diagnosed with either lymphoma or myeloma.
The patient is scheduled for a procedure to collect stem cells from the blood at a specified hospital.
Written consent to participate in the trial is required.
The patient must be at least 18 years old and weigh between 50 and 100 kg.
Step 2
Preparation for stem cell collection
The patient receives a single dose of heparin sodium intravenously. This is a solution for injection.
The purpose of this dose is to increase the yield of stem cells collected from the blood.
Step 3
Stem cell collection
The collection of stem cells begins on monitoring day 1 or 2.
The process involves collecting stem cells from the blood, which is then measured and adjusted based on the patient's weight and the volume of blood processed.
Step 4
Monitoring and assessment
The primary goal is to evaluate the yield of stem cells collected after the first day.
A portion of patients may undergo repeated blood tests during the collection to assess the increase in stem cells over time.
Safety assessments related to the administration of heparin are conducted through medical record reviews to identify any suspected bleeding complications or other adverse events.
Step 5
Additional analysis
For some patients, the stem cell product is analyzed using advanced methods not typically part of routine clinical practice. This includes techniques like flow cytometry and gene expression analysis.

Who can join the trial?

6 criteria

Have been diagnosed with myeloma or lymphoma. These are types of blood cancers.
Are scheduled for an autologous peripheral stem cell harvest at Karolinska University Hospital. This means collecting your own stem cells from your blood.
Have given written consent to participate in the trial. This means you have agreed in writing to join the study.
Are 18 years old or older.
The stem cell harvest starts on monitoring day 1 or 2. This refers to the specific days when the procedure begins.
Current weight is between 50 and 100 kg.

Who cannot join the trial?

2 criteria

Patients with **myeloma** cannot participate. Myeloma is a type of cancer that affects certain blood cells in the bone marrow.
Patients with **lymphoma** cannot participate. Lymphoma is a type of cancer that starts in the cells of the lymphatic system, which is part of the body's immune system.

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Karolinska University Hospital
Solna, Sweden

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Investigated drugs

Heparin is a medication used in this trial to help increase the yield of stem cell collection from patients with lymphoma or myeloma. It is given as a single dose before the collection process. The purpose of using heparin in this trial is to see if it can effectively improve the number of stem cells collected from the blood, which can be important for future treatments.

What is already known about the treatment

Heparin – Heparin is administered as a single bolus injection, typically given intravenously. It is currently being studied in clinical trials for its potential to enhance the collection of hematopoietic stem cells in patients with lymphoma or myeloma. The main therapeutic indication is to improve the yield of stem cell collection prior to transplantation. At the molecular level, heparin works by activating antithrombin III, which in turn inhibits thrombin and factor Xa, reducing blood clot formation. It is classified as an anticoagulant, commonly used to prevent and treat blood clots.

Investigated diseases

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. As the disease progresses, abnormal plasma cells multiply and accumulate in the bone marrow, leading to bone damage and affecting the production of normal blood cells. This can result in symptoms such as bone pain, fatigue, and frequent infections. Over time, the disease can cause complications like anemia, kidney problems, and weakened bones. The progression of Multiple Myeloma can vary, with periods of stability and periods of active disease.
Lymphoma
Lymphoma is a group of blood cancers that develop in the lymphatic system, which is part of the body's immune system. It begins when a type of white blood cell, called a lymphocyte, grows uncontrollably. As the disease progresses, these abnormal cells can form tumors in lymph nodes and other parts of the body. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. Lymphoma can be classified into two main types: Hodgkin lymphoma and non-Hodgkin lymphoma, each with different patterns of progression. The disease can spread to other organs and tissues, affecting their function.