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Study Lead Organization (sponsor)
Protocol number CA088-1007
QUINTESSENTIAL-2 is a clinical study for individuals with relapsed multiple myeloma who currently or previously experienced relapse during or shortly after treatment with the medication lenalidomide. The study investigates whether a new type of cell therapy based on the patient’s own immune cells—called arlo-cel (CAR T-cell therapy)—can control the disease more effectively than current standard treatments.
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If you have relapsed multiple myeloma and have been exposed to lenalidomide, this study may be relevant for you.
What is Multiple myeloma?
Multiple myeloma is a type of cancer affecting plasma cells, a type of white blood cell in the bone marrow that helps the body fight infections. Healthy plasma cells produce antibodies to combat bacteria and viruses. In multiple myeloma, cancer cells accumulate in the bone marrow, displacing healthy cells. This can lead to symptoms like bone pain, infections, and fatigue.
Even with new treatments, multiple myeloma is typically not curable. Most patients experience relapse, and over time, the disease becomes harder to treat. When cancer no longer responds to medications, new treatment options are needed.
Arlo-cel (also known as BMS-986393) is a type of CAR T-cell therapy. It uses your own immune cells (T-cells), collected and modified in a laboratory so they can better recognize and attack myeloma cells. The modified cells target a specific protein called GPRC5D found on cancer cells.
Although arlo-cel is still under investigation and not yet approved, previous studies have shown promising results. The treatment appears effective, and side effects are generally manageable by healthcare professionals.
In this study, researchers compare arlo-cel with two standard treatments:
DPd (daratumumab, pomalidomide, dexamethasone)
Kd (carfilzomib, dexamethasone)
All medicines in the study — except arlo-cel — are already approved and well known to doctors.
What treatments are given in the study?
Experimental Treatment:
Your own immune cells (T cells) are collected and modified in a lab to better target myeloma cells.
You initially receive a brief chemotherapy regimen (cyclophosphamide and fludarabine) to prepare your body.
You then receive a one-time infusion of arlo-cel (BMS-986393).
You will also receive standard multiple myeloma medicines decided by your doctor:
DPd (daratumumab, pomalidomide, dexamethasone)
Kd (carfilzomib, dexamethasone)
Control group:
You receive a standard combination therapy for multiple myeloma:
DPd (daratumumab, pomalidomide, dexamethasone)
Kd (carfilzomib, dexamethasone)
The participants in both groups are closely monitored throughout the study by the study team.
This study may be for you if:
You are 18 years or older.
Have relapsed or refractory multiple myeloma (RRMM).
Have previously received 1 to a maximum of 3 lines of treatment, potentially including:
A proteasome inhibitor (PI)
An immunomodulatory drug (IMiD)
An anti-CD38 monoclonal antibody
You have been exposed to lenalidomide with a minimum of two consecutive cycles.
You have measurable disease (visible in tests).
You are in generally good health with good organ function.
You have an ECOG performance status of 0 or 1 (you are fully active or only slightly limited).
You can take part in regular clinic visits and testing.
You cannot participate if you:
Have a known history of multiple myeloma affecting your central nervous system (CNS).
Have non-secretory myeloma or solitary plasmacytomas with no measurable signs of disease.
Need urgent treatment due to rapidly progressing disease.
Have other serious health conditions that could interfere with study participation.
Additional inclusion and exclusion criteria defined in the study protocol may apply.
How is the study designed?
It is an open study, meaning that both you and the study doctor know which treatment you are receiving. There are three separate parts of the study.
Total duration of the study: Around 5-7 years start to end of study.
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Screening tests will be done to check if you can take part in the study. If you’re eligible, a computer will randomly assign you—to one of two treatment groups: Arm A (arlo-cel) or Arm B (standard treatment: DPd or Kd)
time:
During each visit, the study team will check your health, review any side effects, and monitor your progress.
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You will be randomly assigned to one of two groups, Arm A or Arm B:
Arm A
You will first undergo a procedure called leukapheresis, where your T cells are collected from your blood. These cells are then sent to a lab to produce arlo-cel (also called BMS-986393). While your cells are being prepared, you will receive standard myeloma medicines chosen by your doctor (about 4–5 weeks).
About 3 days before the arlo-cel infusion, you will receive a short course of chemotherapy to prepare your body.
After that, you’ll receive a one-time infusion of arlo-cel.
You will stay in the hospital for at least 7 days after the infusion so the team can monitor for side effects.
From day 8 and for at least 4 more weeks, you must have 24-hour caregiver support and stay within 120 minutes of the hospital, in case of delayed side effects.
Duration: The full treatment period lasts about 8–12 weeks, with around 12 study visits from leukapheresis until 28 days after the infusion (not including the standard multiple myeloma treatment visits while arlo-cel is being produced).
Arm B
If you are in the standard treatementtreatment group, you will receive standard myeloma medicines on a regular schedule. The treatment period will depend on how you respond to treatment, how well you tolerate it, and whether you want to stay in the study.
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After the treatment period is over, you will continue to attend follow-up visits. This part of the study is important to understand how you are doing and how the study treatment is affecting you.
You receive all study-related care and medication at no cost.
Travel support and all expenses related to the study will be covered.
Your health will be monitored closely by a specialist team.
Side effects can occur during or after treatment or procedures.
Some people experience side effects, while others do not.
Side effects may
Go away on their own
Last a long time
Be serious or even life-threatening
The treatment may affect the brain or nervous system.
Because of this, you should not drive or use heavy machinery for at least 8 weeks after receiving the arlo-cel infusion.
The study treatment may not improve your condition.
Your condition may stay the same or get worse.
Everyone responds differently to treatment.
There may be unknown risks, as the treatment is still being studied.
As part of the study, you will have:
Blood tests
Bone marrow tests
Imaging (like scans, if needed)
Physical exams
Medication and symptom check-ins
Pregnancy testing (if applicable)
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Have questions about our clinical studies or need more information on how to participate. Our team is here to provide you with all the details you need. Don't hesitate to reach out to the study team today!
Helpful Information
The Norwegian Blood Cancer Association
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