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Introducing
DARZALEX FASPRO® + VRd

The newest FDA-approved
treatment
combination for patients
who are
newly diagnosed with
multiple myeloma
and eligible to
receive a stem cell transplant*

FDA=U.S. Food and Drug
Administration; VRd=bortezomib (V) + lenalidomide (R) + dexamethasone (d).

*Your doctor will determine if you are eligible to receive a type of stem cell transplant that uses your own stem cells.

now_approved
COMING SOON!

Todd & Diane's story

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Hear from Todd, a newly diagnosed, transplant-eligible patient, along with his wife and care partner, Diane, about their experience with DARZALEX FASPRO® + VRd

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About DARZALEX FASPRO® + VRd

DARZALEX FASPRO® is used with other medicines, with or without a stem cell transplant 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.

For patients 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 blood stream 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

A clinical trial compared patients on the DARZALEX FASPRO® + VRd treatment regimen with patients who received VRd treatment alone. Explore the tabs below to learn more about the study, side effects, and dosing for DARZALEX FASPRO®.

In a clinical trial, DARZALEX FASPRO® was studied in combination with bortezomib, lenalidomide, and dexamethasone (DARZALEX FASPRO® + VRd) in induction and consolidation, compared to treatment with VRd.

Who participated?

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709 people

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Newly diagnosed with multiple myeloma

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Eligible to receive a type of stem cell transplant that uses the patient's own stem cells*

What were the goals of the study?

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The main goal was to measure how long people lived without their multiple myeloma getting worse

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A second goal was to measure response to treatment using markers in blood, urine, and bone marrow

What treatments were compared?

DARZALEX FASPRO® +VRd group treatment steps 1 through 4Treatment steps for DARZALEX FASPRO® +VRd group

*Your doctor will determine transplant eligibility.

Treatment restarted at week 1 after recovery from stem cell transplant.

In a clinical trial,

More people in the DARZALEX FASPRO® + VRd group lived progression free

85% lived without their disease getting worse at 48 months85% lived without their disease getting worse at 48 months

In a clinical trial,

In people who received DARZALEX FASPRO® + VRd for induction and consolidation:

45% achieved complete response or better45% achieved complete response or better58% maintained MRD negativity for at least 12 months58% maintained MRD negativity for at least 12 months

In people who achieved complete response or better during induction and consolidation, 77% (121 out of 158) on DARZALEX FASPRO® + VRd also achieved MRD negativity, compared with 59% (72 out of 123) treated with VRd alone

Response refers to how well the multiple myeloma cells in your body are being controlled by therapy. As response deepens (or gets better), fewer cancer cells remain. You can have a partial response, a very good partial response, or a complete response.

Minimal residual disease (MRD) negativity is another form of response. This is currently the most sensitive way to determine how well a treatment works because it can detect a very small number of cancer cells.

Complete response and MRD negativity are 2 measurements that indicate deeper response

*Progression-free survival refers to the length of time a person lives without disease progression or death.

48-month estimate based on a median follow-up of 47.5 months for the DARZALEX FASPRO® + VRd and VRd groups.

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®.

You may experience side effects from treatment. Side effects are an unwanted or unexpected reaction to a drug that can occur anywhere in your body.

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

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  • 7% had a reaction with the first injection
  • 0.2% 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 are:

  • cold-like symptoms (upper respiratory infection)
  • decreased red blood cell counts

Skin reactions at or near the injection site (local), including injection site reactions, can happen with DARZALEX FASPRO®

7% icon7% icon

In clinical studies, 7% of patients had an injection site reaction with DARZALEX FASPRO®.

Symptoms at the site of injection may include itching, swelling, bruising, pain, rash, bleeding, or redness of the skin.

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

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®.

Dosing for DARZALEX FASPRO® when given in combination with VRd

INDUCTION: DARZALEX FASPRO® + VRd

(Given before stem cell transplant)

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DARZALEX FASPRO® is given every week

Weeks 1 to 8 8 doses total

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DARZALEX FASPRO® is given every 2 weeks

Weeks 9 to 16 4 doses total

Stop for high-dose chemotherapy and a stem cell transplant that uses your own stem cells

CONSOLIDATION: DARZALEX FASPRO® + VRd

(Given after stem cell transplant)

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DARZALEX FASPRO® is given every 2 weeks

Weeks 1 to 8* 4 doses total

Your care team will determine the dosing for bortezomib (V), lenalidomide (R), and dexamethasone (d) using each drug's product information.

*Treatment restarted at week 1 after recovery from stem cell transplant.

MRD=minimal residual disease; R=lenalidomide; VRd=bortezomib (V) + lenalidomide (R) + dexamethasone (d).

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Learn more about DARZALEX FASPRO® + VRd

Download a brochure and ask your doctor about the newest treatment for people newly diagnosed with multiple myeloma who are eligible to receive a stem cell transplant*

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*Your doctor will determine transplant eligibility.