Quad DARZALEX FASPRO® treatment combination results
A clinical study comparing DARZALEX FASPRO® + VRd vs VRd alone in people with newly diagnosed multiple myeloma who are not eligible for a stem cell transplant
DARZALEX FASPRO® is used with other medicines or by itself depending on your doctor’s treatment plan. One combination is DARZALEX FASPRO® + VRd (bortezomib, lenalidomide, and dexamethasone), which is known as a quadruplet, or quad, therapy and consists of 4 treatments.
The CEPHEUS clinical study tested DARZALEX FASPRO® + VRd in people who are not eligible for a transplant. The study compared DARZALEX FASPRO® + VRd vs VRd alone.
Who took part in the study?
395
people total participated in the study
197
people were treated with DARZALEX FASPRO® + VRd
198
people were treated with VRd alone
Everyone who participated was newly diagnosed with multiple myeloma. People from age 31 to 80 (median age 70) who could not get a stem cell transplant were included.*
*A doctor determined transplant eligibility for each person.
What were the goals of the clinical study?
The main goal was to measure something called minimal residual disease (MRD) negativity.
MRD negativity means that after treatment, not one cancer cell was detected out of every 100,000 cells. In this trial, MRD negativity was studied in people.
There were other goals during the study. One goal was to see how long people lived without their disease getting worse or dying. Another goal was to measure the response people had during the study.
Response is used to measure how well multiple myeloma cells in your body are being controlled by therapy. As a response deepens (or gets better) fewer cancer cells remain. You can have a partial response, a very good partial response, or a complete response or better.
Complete response means that you have responded to treatment; there are no signs of cancer seen in imaging, blood, or bone marrow tests. Your doctor can also check for minimal residual disease (MRD). MRD negativity means that after treatment, not one cancer cell was detected out of every 100,000 cells. These measures represent thorough responses; however, they do not mean that the cancer is cured.
Key results in people treated with DARZALEX FASPRO® + VRd vs VRd alone in the study after median follow-up of 22 months
MRD Negativity
In this clinical study, more people who were treated with DARZALEX FASPRO® + VRd achieved MRD negativity with a complete response or better vs those who were treated with VRd alone
of people who were treated with
DARZALEX FASPRO® + VRd achieved MRD negativity with a complete response or better after 22 months
vs 35% of people who were treated with VRd alone.
Complete Response or Better
More people who were treated with DARZALEX FASPRO® + VRd achieved a complete response or better compared with those who were treated with VRd alone
of people in this clinical study who were treated with DARZALEX FASPRO® + VRd had a complete response after 22 months
vs 59% of people treated with VRd alone.
More people who were treated with DARZALEX FASPRO® + VRd achieved sustained MRD negativity than those treated with VRd alone
Sustained MRD negativity means that doctors tested your bone marrow at 2 separate times, at least one year apart, and found no signs of multiple myeloma in the bone marrow either time—showing the disease stayed at very low levels over time.
After a median follow-up of 39 months
of people who were treated with DARZALEX FASPRO® + VRd achieved sustained MRD negativity
vs 25% of people who were treated with VRd alone.
After a median follow-up of 39 months, people who were treated with DARZALEXFASPRO® + VRd had a better chance of living progression free*
of people treated with DARZALEX FASPRO® + VRd were still alive without their disease progressing
vs 61% of those treated with VRd alone.
*Living progression free refers to the length of time a person lived without having their disease getting worse, or passing away.
DARZALEX FASPRO® + VRd is available for people who are eligible to receive a stem cell transplant*
The PERSEUS clinical trial studied DARZALEX FASPRO® in combination with bortezomib, lenalidomide, and dexamethasone (DARZALEX FASPRO® + VRd) in induction and consolidation, compared to treatment with VRd alone.
*Your doctor will determine if you are eligible to receive a type of stem cell transplant that uses your own stem cells.
Who took part in the study?
709
people total participated in the study
355
people were treated with DARZALEX FASPRO® + VRd
354
people were treated with VRd alone
Everyone who participated in the study was newly diagnosed with multiple myeloma and was eligible to receive a type of stem cell transplant that uses the person’s own stem cells.*
*Your doctor will determine if you are eligible to receive a type of stem cell transplant that uses your own cells.
For people eligible for transplant, first-line therapy may include different treatment phases:
Induction therapy: The first treatment given before stem cell transplant, aimed at reducing the number of cancer cells. It typically includes a combination of medicines
Stem cell transplant: A procedure that uses your own stem cells, which are collected, preserved, and infused into your bloodstream to restore blood cell production
Consolidation therapy: The same medications used for induction therapy, given over a shorter period of time to kill cancer cells that may be left in the body
Post-consolidation therapy: Following consolidation, your doctor may prescribe additional medication to maintain your results
What were the goals of the study?
The main goal was to measure how long people lived without their multiple myeloma getting worse. A second goal was to measure response to treatment using markers in blood, urine, and bone marrow.
The study compared DARZALEX FASPRO® + VRd vs VRd alone.
More people in the DARZALEX FASPRO® + VRd group lived progression-free*
reduction in the risk of disease progression or death with DARZALEX FASPRO® + VRd vs VRd alone
vs 61% of those treated with VRd alone.
of people who were treated with DARZALEX FASPRO® + VRd lived without their disease getting worse after 48 months.†
vs 68% who were treated with VRd alone
*Living progression-free refers to the length of time people lived without having their disease getting worse, or passing away.
†48-month estimate based on a median follow-up of 47.5 months for the DARZALEX FASPRO® + VRd and VRd groups.
In people who were treated with DARZALEX FASPRO® + VRd for induction and consolidation
(158 out of 355) achieved complete response or better.
vs 35% (123 out of 354) who were treated with VRd alone.
(204 out of 355) achieved MRD negativity.
vs 33% (115 out of 354) who were treated with VRd alone.
Complete response means there are no signs of cancer seen in imaging, blood, or bone marrow tests, but a small number of cells may still exist under the surface.
In people who achieved complete response or better during induction and consolidation
(121 out of 158) treated with DARZALEX FASPRO® + VRd also achieved MRD negativity.
vs 59% (72 out of 123) treated with VRd alone.
Minimal residual disease (MRD) means the amount of myeloma cells remaining after a course of treatment, as measured by very sensitive testing, can be as low as one myeloma cell in 1 million normal cells.
Side effects for DARZALEX FASPRO®
Do not receive DARZALEX FASPRO® if you have a history of a severe allergic reaction to daratumumab, hyaluronidase, or any of the ingredients in DARZALEX FASPRO®.
Serious allergic reactions and other severe injection-related reactions
Serious allergic reactions and reactions due to release of certain substances by your body (systemic) that can lead to death can happen with DARZALEX FASPRO®. Your doctor or care team may temporarily stop or completely stop treatment if you have a serious reaction.
Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an injection of DARZALEX FASPRO® :
- Shortness of breath or trouble breathing
- Dizziness or lightheadedness (hypotension)
- Cough
- Wheezing
- Heart beating faster than usual
- Low oxygen in the blood (hypoxia)
- Throat tightness or irritation
- Runny or stuffy nose
- Headache
- Itching
- High blood pressure
- Eye pain
- Nausea
- Vomiting
- Chills
- Fever
- Chest pain
- Blurred vision
In studies, injection-related reactions decreased over time
7% had a reaction with the first injection
0.5% had a reaction with the second injection
1% had a reaction with the following injections combined
Not everyone responds to treatment the same. Talk to your care team about any side effects that are bothersome or do not go away.
The most common side effects of DARZALEX FASPRO® when used alone include:
- cold-like symptoms (upper respiratory tract infection)
- muscle, bone, and joint pain
- tiredness
- diarrhea
- rash
- trouble sleeping, including sleep apnea and restless legs
- nerve problems, including increased or decreased sensitivity to touch, temperature, or pain; loss of smell; and numbness, tingling, or burning sensations
- injection site reactions
Skin reactions at or near the injection site (local), including injection site reactions, can happen with DARZALEX FASPRO®
In a safety analysis of patients from clinical studies, 8% of patients had local injection-site reactions with injection site redness (erythema) and injection site rash being the most frequent.
Symptoms at the site of injection may include itching, swelling, bruising, pain, rash, bleeding, or redness of the skin. These reactions sometimes happen more than 24 hours after an injection of DARZALEX FASPRO®.
The most common side effects of DARZALEX FASPRO® when used in combination with other therapies include:
- Tiredness
- Nausea
- Diarrhea
- Shortness of breath
- Trouble sleeping
- Headache
- Rash
- Fever
- Cough
- Muscle spasms
- Back pain
- Vomiting
- High blood pressure
- Muscle, bone, and joint pain
- Cold-like symptoms (upper respiratory infection)
- Nerve damage causing tingling, numbness, or pain
- Constipation
- Lung infection (pneumonia)
- Swollen hands, ankles, or feet
- Decreased red blood cell counts
Infections
DARZALEX FASPRO® can cause serious life-threatening infections that can lead to death. Tell your healthcare provider right away if you develop a fever, trouble breathing, cough, burning or pain when you urinate, or any other signs and symptoms of infection during treatment.
Decreased blood cell counts and changes in blood tests
Your doctor will do blood tests to check your blood cell count and match your blood type before treatment. DARZALEX FASPRO® can:
- Decrease white blood cell counts (help fight infections) and blood cells called platelets (help clot blood). Decreases are common with DARZALEX FASPRO® but can be severe. Tell your doctor if you get a fever or develop signs of bruising or bleeding
- Affect the results of blood tests to match your blood type. These changes can last for up to 6 months after your final dose of DARZALEX FASPRO®. Tell all of your healthcare providers that you are being treated with DARZALEX FASPRO® before receiving blood transfusions
These are not all of the possible side effects of DARZALEX FASPRO®. Speak with your doctor about the side effects that you may experience with DARZALEX FASPRO®.