Study on the Safety and Effectiveness of Motixafortide and G-CSF for Stem Cell Collection in Patients with Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying a condition called Multiple Myeloma, which is a type of cancer that affects the blood cells in the bone marrow. The study is investigating a treatment that combines a medication called BL-8040 (also known as Motixafortide) with another drug called G-CSF. The purpose of this study is to see if this combination is better than using a placebo with G-CSF for helping the body produce more stem cells. These stem cells are important for a procedure called autologous transplantation, where a patient’s own stem cells are collected and then given back to them to help treat the disease.

Participants in the study will receive either the combination of BL-8040 and G-CSF or a placebo with G-CSF. The study will be conducted in a way that neither the participants nor the researchers know who is receiving which treatment, to ensure unbiased results. The treatment involves injections, and the study will monitor how well the body can produce and collect stem cells over a couple of sessions. The goal is to collect a certain number of stem cells that are needed for the transplantation process.

The study will also look at how quickly the body recovers after the transplantation, focusing on how fast the blood cells return to normal levels. This includes checking the recovery of white blood cells and platelets, which are important for fighting infections and preventing bleeding. The study will follow participants for several months after the transplantation to see how well the stem cells continue to work in the body. This research aims to improve the treatment process for patients with Multiple Myeloma by making stem cell collection more effective and efficient.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. Consent is required before participation begins.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes a review of medical history and a physical examination.

3 medication administration

The patient will receive a single dose of either BL-8040 or a placebo. This is administered as a subcutaneous injection.

The injection is prepared by reconstituting a lyophilized powder with 2 mL of 0.45% Sodium Chloride.

4 G-CSF administration

The patient will also receive G-CSF (Granulocyte-Colony Stimulating Factor) to help mobilize stem cells. The dosage and frequency will be determined by the study protocol.

5 apheresis sessions

Up to two apheresis sessions will be conducted to collect stem cells. The goal is to collect at least 6.0 x 10^6 CD34+ cells per kilogram of body weight.

6 monitoring and follow-up

The patient will be monitored for any side effects or reactions to the treatment. Regular follow-up visits will be scheduled to assess the patient’s health and the efficacy of the treatment.

7 transplantation preparation

If sufficient stem cells are collected, the patient will be prepared for autologous hematopoietic cell transplantation.

8 post-transplantation monitoring

After transplantation, the patient will be monitored for engraftment and recovery. This includes checking for neutrophil and platelet engraftment and assessing graft durability at various intervals up to 12 months post-transplantation.

Who Can Join the Study?

Patients must be between the ages of 18 and 78 years.
Women who can have children must agree to use two methods of effective birth control. This includes one barrier method like a condom or diaphragm, combined with a spermicide, and one hormonal method like birth control pills or patches. Alternatively, they can use a highly effective method like an intrauterine device (IUD) or have a partner who has had a vasectomy. These methods must be used before joining the study and continue for 30 days after the last dose of the study treatment.
Men must agree to use an effective method of birth control starting from the first day of G-CSF administration until 30 days after the last dose of the study drug.
Patients must sign a consent form to participate in the study.
Patients must have a confirmed diagnosis of Multiple Myeloma before joining the study.
Patients must wait at least one week (7 days) after their last cycle of chemotherapy before receiving the first dose of G-CSF for mobilization.
Patients must be eligible for Autologous Hematopoietic Stem Cell Transplantation as determined by the study doctor.
Patients should be in their first or second complete response (CR) or partial response (PR) to treatment.
Patients must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest during the day.
Patients must have adequate organ function, which includes:
- White blood cell counts above a certain level.
- Neutrophil count above a certain level.
- Platelet count above a certain level.
- Renal function with a GFR value of at least 15 mL/min/1.73^2.
- Liver function with ALT and AST levels not more than 2.5 times the upper limit of normal, and Total Bilirubin not more than 2 times the upper limit unless the patient has Gilbert disease.
- Coagulation tests with INR or PT not more than 1.5 times the upper limit unless the patient is on blood thinners, as long as the tests are within the therapeutic range.
Women who can have children must have a negative pregnancy test before starting the study and within 72 hours before the first administration of G-CSF.

Who Cannot Join the Study?

Patients who have a different type of cancer other than Multiple Myeloma. Multiple Myeloma is a type of blood cancer that affects plasma cells in the bone marrow.
Patients who have not been diagnosed with Multiple Myeloma.
Patients who are not eligible for autologous hematopoietic cell transplantation. This is a procedure where a patient’s own stem cells are collected, stored, and then given back to them after intensive treatment.
Patients who are unable to undergo the process of stem cell mobilization. This is a procedure to increase the number of stem cells in the bloodstream for collection.
Patients who have medical conditions that would make it unsafe to participate in the study.
Patients who are not within the specified age range for the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to comply with the study procedures.
Patients who have participated in another clinical trial recently.
Patients who have allergies or reactions to the study medications.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Grande Ospedale Metropolitano Bianchi Melacrino Morelli	Reggio Calabria	Italy
Hospital Universitario Ramon Y Cajal	Madrid	Spain
University Of Debrecen	Debrecen	Hungary
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet	Budapest	Hungary
Utaswmemps Huapqktb Cwqyqwz	Cologne	Germany
Hgpsavzv Dq Lz Sgemq Cwuh I Sied Pzg	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	20.04.2018
Hungary	Not recruiting	20.04.2018
Italy	Not recruiting	20.04.2018
Spain	Not recruiting	20.04.2018

Trial locations

Investigated drugs:

Motixafortide

BL-8040 is an experimental medication being tested for its ability to help move stem cells from the bone marrow into the bloodstream. This process is important for collecting stem cells that can be used later in a transplant. In this study, BL-8040 is being combined with another medication to see if it can improve the collection of stem cells in patients with multiple myeloma.

G-CSF (Granulocyte-Colony Stimulating Factor) is a medication that helps the body produce more white blood cells. It is commonly used to help move stem cells from the bone marrow into the bloodstream, making it easier to collect them for a transplant. In this study, G-CSF is used in combination with BL-8040 to see if this combination is more effective than using G-CSF alone.

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. These cancerous plasma cells multiply rapidly, leading to an overproduction of abnormal proteins that can cause damage to bones, kidneys, and the immune system. As the disease progresses, it can lead to bone pain, fractures, anemia, and increased susceptibility to infections. The accumulation of these abnormal cells can also interfere with the production of normal blood cells, leading to various complications. Over time, the disease can cause significant damage to the bones and other organs, impacting overall health and quality of life.

Trial ID:

2024-511953-23-00

Protocol code:

BL-8040.SCM.301

NCT ID:

NCT03246529

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety and Effectiveness of Motixafortide and G-CSF for Stem Cell Collection in Patients with Multiple Myeloma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?