Study of Ciltacabtagene Autoleucel and Drug Combination for Treatment of High-Risk Smoldering Multiple Myeloma

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What is this study about?

This study focuses on patients with High-risk Smoldering Multiple Myeloma, which is an early form of blood cancer that may progress to active multiple myeloma. The main treatment being tested is Ciltacabtagene Autoleucel, a type of cell therapy where a patient’s own immune cells are modified in a laboratory to fight cancer cells. Before receiving this treatment, patients will receive a combination of other medications including Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone.

Additional medications used in the study include Fludarabine and Cyclophosphamide, which are given to prepare the body for the cell therapy. The purpose of this research is to determine how well this treatment combination works and how safe it is for patients with high-risk smoldering multiple myeloma. The treatment involves receiving chemotherapy medications through infusions into veins or as injections under the skin, as well as taking some medications by mouth.

The study will monitor patients for several years after treatment to check how well the therapy works and to watch for any side effects. Doctors will regularly examine the bone marrow to look for any remaining cancer cells and will track how long patients remain free from disease progression. Blood tests will be performed regularly to monitor the patient’s immune system and overall health.

1 Initial treatment phase

You will receive a combination of medications known as Dara-VRD, which includes:

– Daratumumab given as an injection under the skin

– Bortezomib given as an injection under the skin

– Lenalidomide taken by mouth

– Dexamethasone taken by mouth

2 Cell collection procedure

Your blood cells will be collected through a procedure called apheresis

These cells will be used to create your personalized treatment

3 Preparation treatment

You will receive medications to prepare your body for the cell therapy:

– Fludarabine given through an intravenous line

– Cyclophosphamide given through an intravenous line

4 Cell therapy administration

You will receive ciltacabtagene autoleucel (cilta-cel), which are your modified cells

The cells will be given through an intravenous infusion

The dose will be between 3.2 × 10^6 and 1 × 10^8 cells

5 Follow-up period

Your progress will be monitored for up to 5 years after receiving the cell therapy

Regular tests will be performed to check your response to treatment

Blood and bone marrow samples will be collected to monitor your condition

Who Can Join the Study?

Must be at least 18 years of age or legally able to consent
Must have high-risk smoldering multiple myeloma meeting specific medical criteria, including certain protein levels in blood and bone marrow
Must have good physical function status (ECOG score of 0 or 1, meaning able to perform daily activities)
Must have adequate kidney function (filtration rate of at least 40 mL/min)
Must have acceptable liver function and blood test results, including:
- Adequate hemoglobin levels (at least 8.0 g/dL)
- Sufficient white blood cell counts
- Adequate platelet levels (at least 75,000 per microliter)
Must be either HIV-negative or have controlled HIV disease if positive
For women who can become pregnant:
- Must have negative pregnancy test
- Must use effective birth control during study and 6 months after
- Must not donate eggs during study and 6 months after treatment
For men:
- Must use contraception during study and for 1 year after treatment
- Must not donate sperm during study and for 1 year after treatment
- Must not plan to father children during study and for 1 year after
Must sign informed consent forms
Must be willing to follow study requirements and restrictions
Must not be participating in other clinical trials

Who Cannot Join the Study?

Prior treatment with any anti-myeloma therapy (including daratumumab or any other monoclonal antibodies)
History of plasma cell leukemia (a condition where abnormal plasma cells are found in the blood)
Active or prior malignancy (cancer) within 3 years before starting the study
Known allergies or severe reactions to study medications
Significant heart conditions, including:
- Heart failure with reduced heart function
- Uncontrolled irregular heartbeat
- Heart attack within the past 6 months
Severe kidney problems (creatinine clearance less than 30 mL/min)
Active or chronic liver disease
Active, uncontrolled infections including:
- HIV infection
- Active hepatitis B or hepatitis C
Pregnant or breastfeeding women
Unable to take blood-thinning medications
Participation in another clinical trial within 30 days before this study
Any condition that, in the opinion of the study doctor, would interfere with safe participation in the study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hzliqstj Utemnazcmospg Mnvewop Db Vttzibnzwm	Santander	Spain
Ivazpefc Cgptpv Dcaxaocuvxvxqmqpl	L'hospitalet De Llobregat	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	16.09.2024

Trial locations

Investigated drugs:

Ciltacabtagene autoleucel (cilta-cel) is a type of CAR T-cell therapy, which means it uses your own modified immune cells to fight cancer. This treatment involves collecting your T-cells (a type of white blood cell), modifying them in a laboratory to recognize and attack cancer cells, and then returning them to your body to fight the disease. This therapy is specifically designed to target multiple myeloma cells.

Daratumumab (Dara) is an antibody medication that works by helping your immune system fight certain cancer cells. It attaches to a specific protein on cancer cells, making it easier for your immune system to identify and destroy them.

VRD is a combination therapy that includes three medications working together:
– Bortezomib (Velcade) is a targeted therapy that blocks certain proteins to stop cancer cells from growing
– Lenalidomide (Revlimid) is a medication that helps your immune system fight cancer cells and can also block blood supply to tumors
– Dexamethasone is a steroid medication that helps reduce inflammation and can make other cancer treatments more effective

Investigated diseases:

Plasma cell myeloma

Multiple Myeloma (Smoldering) – A precursor condition to multiple myeloma where abnormal plasma cells accumulate in the bone marrow but haven’t yet caused symptoms or organ damage. In this early stage, the body produces abnormal proteins (M proteins) that can be detected in blood tests, but the condition hasn’t progressed to cause bone damage, kidney problems, or other complications. The high-risk form shows certain characteristics that suggest a higher likelihood of progression to active multiple myeloma. The condition is monitored through regular blood tests and bone marrow examinations to track protein levels and plasma cell counts.

Trial ID:

2023-510560-12-00

Protocol code:

GEM-CAR-HiRiSMM

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Ciltacabtagene Autoleucel and Drug Combination for Treatment of High-Risk Smoldering Multiple Myeloma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?