Learn about DARZALEX FASPRO® + VRd, the latest FDA-approved quad treatment combination for people with newly diagnosed multiple myeloma who are not eligible to receive a stem cell transplant

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DARZALEX FASPRO ® is now FDA approved as the first therapy for use alone to treat adults with high-risk smoldering multiple myeloma.

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Starting TreatmentTriplet Combination Treatment Results

Triplet DARZALEX® treatment combination results

DARZALEX® + Rd was studied in people with newly diagnosed multiple myeloma

DARZALEX® is used with other medicines or by itself depending on your doctor's treatment plan. One combination is DARZALEX® + Rd (lenalidomide and dexamethasone), which is known as a triplet therapy, and consists of 3 treatments.

Who participated in the study?

In this study, DARZALEX® was evaluated in 737 people. The study looked at people with newly diagnosed multiple myeloma and were not eligible for a stem cell transplant taking DARZALEX® in combination with lenalidomide + dexamethasone (Rd) vs Rd alone.

737

people total participated in the study

368

people were treated with DARZALEX® + Rd

369

people were treated with Rd alone

What were the goals of the clinical study?

The main goal of the study was to measure the length of time people lived without having their multiple myeloma get worse, or passing away. Another goal was to measure overall response rate, which is the percentage of people who responded to treatment. People followed the complete dosing schedule for DARZALEX® + lenalidomide + dexamethasone (DRd).

Key study results

After a follow-up time of ~30 months

74%

(271 out of 368) of people in the DARZALEX® + Rd group lived without having their disease get worse, or passing away

vs 61% (226 out of 369) of people in the Rd group.

~90%

of people responded to DARZALEX® + Rd

vs ~8/10 people treated with Rd alone.

~48%

of people had a complete response* or better with DARZALEX® + Rd

vs 25% of people with Rd alone.

*This means the doctor observed no signs or symptoms of the disease as seen through imaging or other specific blood and bone marrow tests after treatment.

After median follow-up of 56 months

The estimated number of patients still alive after 5 years was 67% for patients in the DARZALEX® + Rd group and 54% in the Rd alone group.

After long-term follow-up of a median of 89 months

53% (195 out of 368) of people treated with DARZALEX® + Rd were alive vs 39% (144 out of 369) treated with Rd alone.

Side effects

DARZALEX® may cause serious reactions, including infusion-related reactions. Infusion-related reactions are common with DARZALEX®. Serious allergic reactions and reactions due to release of certain substances by your body (systemic) that can lead to death can happen with DARZALEX®. About half the people treated with DARZALEX® experience an infusion-related reaction. This is most likely to happen during the first infusion and less likely with future infusions.

Your healthcare provider may temporarily stop your infusion or completely stop treatment with DARZALEX® if you have infusion-related reactions. Get medical help right away if you get any of the following symptoms:

  • 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 discomfort
  • Blurred vision

The most common side effects of DARZALEX® include:

  • Cold-like symptoms (upper respiratory infection)
  • Diarrhea
  • Constipation
  • Decreased red blood cell count
  • Nerve damage causing tingling, numbness, or pain
  • Tiredness
  • Swollen hands, ankles, or feet
  • Nausea
  • Cough
  • Fever
  • Shortness of breath
  • Feeling weak

These are not all the possible side effects of DARZALEX®. Call your doctor for medical advice about side effects.

Changes in blood tests

DARZALEX FASPRO® and DARZALEX® can 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® or DARZALEX®. Your healthcare provider will do blood tests to match your blood type before you start treatment. Tell all of your healthcare providers that you are being treated with DARZALEX FASPRO® or DARZALEX® before receiving blood transfusions.

Decreases in blood cell counts

DARZALEX FASPRO® and DARZALEX® can decrease white blood cell counts, which help fight infections, and blood cells called platelets, which help to clot blood. Decreases in blood cell counts are common with DARZALEX FASPRO® and DARZALEX® but can be severe. Your healthcare provider will check your blood cell counts during treatment. Tell your healthcare providers if you develop fever or have signs of bruising or bleeding.

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