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Treatment Name: DVd (Daratumumab + Velcade® (bortezomib) + dexametha­sone)

DVd (Daratumumab + Velcade® (bortezomib) + dexametha­sone) is a Chemotherapy Regimen for Multiple Myeloma (MM)

How does DVd work?
Each of the medications in the DVd (Daratumumab, Velcade, dexamethasone) regimen is designed to kill or slow the growth of myeloma cells.

D - Daratumumab (Darzalex®)
V - Velcade® (bortezomib)
d - dexamethasone (dex)

Goals of therapy:
DVd is not given to cure multiple myeloma, but rather to slow the progression of the disease and to decrease symptoms.

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Schedule

  • Daratumumab intravenous (I.V.) infusion on Days 1, 8, and 15 of Cycles 1, 2, and 3; then Day 1 only of Cycles 4, 5, 6, 7, and 8, then once monthly (every 28 days) thereafter. The time of infusion varies depending upon the tolerability and number of previous infusions
  • Bortezomib subcutaneous (S.Q.) injection on Days 1, 4, 8 and 11 of Cycles 1, 2, 3, 4, 5, 6, 7, and 8
  • Dexamethasone 20 mg (five 4 mg tablets) by mouth on Days 1, 2, then Days 4, 5, then Days 8, 9, then Days 11, 12 of Cycles 1 through 8.

       Cycles 1 through 8 are repeated every 21 days.

Estimated total infusion time for this treatment:

  • For daratumumab, Cycle 1 Day 1 may take up to 8 hours because of the possibility of experiencing infusion reactions. If you do not experience any with the first infusion, Cycle 1 Day 8 may be reduced to 6 hours. If you do not experience any infusion reactions during the first two daratumumab doses, it may only take up to 4 hours after that. There is also a 90-minute rapid infusion option if it is well tolerated
  • On days that only bortezomib and dexamethasone are given, infusion time may be as little as 1 hour
  • Infusion times are based on clinical studies, but may vary depending on doctor preference or patient tolerability. Pre-medications and intravenous (I.V.) fluids, such as hydration, may add more time

DVd is usually given in an outpatient infusion center, allowing the person to go home afterwards. It is repeated every 21 days. This is known as one Cycle. Each cycle may be repeated up to eight times and then ONLY daratumumab is given (no Velcade or dexamethasone) until daratumumab no longer works or until unacceptable side effects occur.

Click here for the common DVd (Daratumumab Velcade Dexamethasone) starting doses.

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Side Effects

In a multi-drug regimen, each medication has unique side effects. When these medicines are given together, drug-related side effects reported in clinical studies give the best estimate of what to expect. In clinical studies, the most commonly reported DVd (daratumumab + Velcade + dexamethasone) side effects are shown here:

  • Increased bleeding risk [low platelet count; thrombocytopenia] (59%)
  • Pins-and-needles feeling in fingers and toes (47%)
  • Diarrhea (32%)
  • Anemia [low red blood cell count] (26%)
  • Sinus infection (25%)
  • Cough (24%)
  • Fatigue (21%)
  • Constipation (20%)
  • Shortness of breath (19%)
  • Low white blood cells (18%)
  • Trouble sleeping (17%)
  • Fluid retention (17%)
  • Fever (16%)
  • Pneumonia (12%)
  • Weakness (9%)
  • High blood pressure (9%)

Approximately 8% of patients discontinued DVd due to unacceptable side effects.

Side effect videos Side Effect Videos
DiarrheaDiarrheaAnemiaAnemiaFatigue Fatigue ConstipationConstipationPainPain

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Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before treatment and periodically during treatment. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), serum free light chains (FLC), quantitative immunoglobulins, plus any others your doctor may order.

How often is imaging needed?
Imaging may be checked during treatment. Imaging may include: bone scans, computerized tomography (CT) scans, or magnetic resonance imaging (MRI).

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue DVd as planned, reduce the dose of future treatments, delay the next dose until the side effect goes away, or switch to an alternative therapy.

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ChemoExperts Tips

  • Approximately 50% of patients experience a daratumumab infusion reaction during the first dose (infusion reactions during subsequent doses are less likely). Acetaminophen (Tylenol®) + antihistamine such as diphenhydramine (Benadryl®) + a corticosteroid such as methylprednisolone (Solu-Medrol®) will be given approximately one hour before each dose of daratumumab to decrease the chance of an infusion reaction
  • Remember to take your corticosteroid such as dexamethasone or methylprednisolone (Solu-Medrol®) on the first and second days after each infusion of daratumumab to decrease the chance of experiencing a delayed infusion reaction
  • If you have an obstructive lung disorder such as COPD or emphysema, you may be instructed to use an inhaler after your infusion of daratumumab
  • If daratumumab alone starts to lose effectiveness while on the once-monthly schedule, your doctor may put you back on a once-weekly schedule to bring the myeloma back in control
  • Therapy with daratumumab and bortezomib can increase your risk of experiencing herpes zoster (shingles). You will be given an anti-viral medication such as acyclovir (Zovirax®) or valacyclovir (Valtrex®) to lessen your risk. These medications should be started within one week of starting treatment with daratumumab and bortezomib and taken until 3 months after therapy is stopped
  • Daratumumab interferes with testing that is done to determine what type of blood you can receive if you need a blood transfusion. This effect can last up to 6 months after completing therapy with daratumumab. Before your first infusion of daratumumab, you will have a blood type-and-screen performed to help determine what type of blood you can receive if you need it in the future. Inform your healthcare provider that you are taking daratumumab if any blood transfusion are planned
  • Daratumumab can affect the results of a test used to assess response to therapy called serum protein electrophoresis (SPEP). Additional testing may be needed to assess your response to therapy with daratumumab
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for multiple myeloma. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for DVd (Daratumumab + Velcade® (bortezomib) + dexametha­sone), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for DVd (Daratumumab + Velcade® (bortezomib) + dexametha­sone). Depending upon your income, they may be able to help cover the cost of:

  • Daratumumab
  • Velcade®
  • Dexamethasone

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as DVd (Daratumumab + Velcade® (bortezomib) + dexametha­sone) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with DVd (Daratumumab + Velcade® (bortezomib) + dexametha­sone)

Individual Drug Label Information

Daratumumab (Darzalex®)

  • Daratumumab is an intravenous infusion
  • Acetaminophen (Tylenol®), diphenhydramine (Benadryl®), and a corticosteroid such as methylprednisolone (Solu-Medrol®) will be given approximately one hour before each dose
  • A corticosteroid such as methylprednisolone (Solu-Medrol®) is taken on the first and second days after each infusion
  • An inhaler may been used after each treatment if you have an obstructive lung disorder such as COPD or emphysema
  • May increase your risk of experiencing herpes zoster (shingles). Acyclovir (Zovirax®) or valacyclovir (Valtrex®) may be taken to lessen your risk
  • Daratumumab interferes with testing that is done to determine what type of blood you can receive if you need a blood transfusion. Inform your healthcare provider that you are taking daratumumab if any blood transfusion are planned
  • Daratumumab can affect the results of a test used to assess response to therapy
  • Females who are of reproductive potential should use contraception during therapy and for at least 3 months after completing therapy
General Daratumumab (Darzalex) Side Effects
  • May cause fatigue
  • Can cause allergy symptoms such as a runny nose
  • Can cause an upper respiratory tract infection or a sinus infection Fever 
  • Diarrhea
  • Shortness of breath
  • Click on the daratumumab (Darzalex) package insert below for reported side effects and possible drug interactions

Side Effect Videos
DiarrheaDiarrheaFatigue Fatigue BleedingBleedingAnemiaAnemiaNeutropenic FeverNeutropenic Fever

See DailyMed package insert.

Velcade® (Bortezomib)

  • Velcade can be given either as an intravenous (I.V.) infusion, but is more commonly administered as a subcutaneous (under the skin, “SubQ”) injection
  • Dosage adjustments may be required for liver dysfunction, low blood counts, or nerve pain
  • Will cause death if administered into the spinal fluid
  • Green tea and green tea extracts may decrease the effectiveness of bortezomib and these should be avoided.
  • Avoid dietary supplementation with ascorbic acid (Vitamin C), which also includes multivitamins that contain ascorbic acid. Normal dietary intake of ascorbic acid does NOT need to be changed
  • Avoid over-the-counter natural products such as St. John’s Wort
General Velcade (Bortezomib) Side Effects 
  • May cause or worsen nerve pain and is more common if bortezomib is given intravenously than subcutaneously
  • Can cause decreases in platelets, red blood cells, and white blood cells leading to increase risk of bleeding, fatigue, and infection
  • May cause reactivation of herpes simplex virus (HSV) or varicella zoster virus (VZV). Prophylactic anti-viral medications should be taken during therapy with bortezomib
  • Can worsen symptoms of heart failure
  • May cause redness or irritation around injection site if given subcutaneously
  • Click on the Velcade (bortezomib) package insert below for reported side effects and possible drug interactions

Side Effect Videos
DiarrheaDiarrheaFatigue Fatigue BleedingBleedingConstipationConstipationPainPain

See DailyMed package insert.

Dexamethasone (Decadron®)

  • Dexamethasone is supplied as an oral tablet or oral liquid
  • Dexamethasone may increase the risk of infection. Depending upon how much dexamethasone is taken, antibiotics may be prescribed to help prevent infection
  • Should be taken with food and with a large glass of water to avoid stomach irritation or ulcers
  • Should be taken before 6 p.m. when possible, to avoid trouble falling asleep
  • May decrease the response to vaccines; vaccines may need to be repeated at a later date to obtain maximal response
  • If taken daily for several days or weeks, the dose of dexamethasone may need to be gradually decreased (tapered) to avoid withdrawal symptoms
  • If you miss a dose, take the next dose as soon as possible
  • Should be stored at room temperature
General Dexamethasone (Decadron) Side Effects
  • May cause high blood sugar, weight gain, irritability, high blood pressure, difficulty sleeping, stomach ulcers, bone loss, muscle weakness
  • Click on the dexamethasone (Decadron) package insert below for reported side effects and potential drug Interactions
See DailyMed package insert.

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References

Palumbo A, Chanan‐Khan A, Weisel K, et al. Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016;375:754-766.

Created: September 14, 2016 Updated: October 5, 2018

What is Multiple Myeloma (MM)?

Multiple Myeloma is a disease of the white blood cells, called plasma cells, found in the blood or bone marrow. Plasma cells are a type of white blood cell known as a B-lymphocyte.

Sometimes plasma cells form collections on bone and weaken or destroy it. These are known as "lytic lesions". Multiple Myeloma is a rare condition with an unknown cause. The stage can vary at diagnosis and throughout treatment. Staging is based on the international staging system (ISS). The type and effectiveness of the treatment may depend upon the stage.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

What does Cure mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, doctors use the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

Common DVd Starting Doses

  • Daratumumab 16 mg/kg intravenous (I.V.) infusion on Days 1, 8, and 15 of Cycles 1, 2, and 3; then Day 1 only of Cycles 4 through 8, then once monthly (every 28 days) thereafter
  • Bortezomib 1.3 mg/m2 subcutaneous (S.Q.) injection on Days 1, 4, 8 and 11 of Cycles 1 through 8
  • Dexamethasone 20 mg (five 4 mg tablets) by mouth on Days 1, 2, then Days 4, 5, then Days 8, 9, then Days 11, 12 of Cycles 1 through 8

         Cycles 1 through 8 are 21 days in duration.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium