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Treatment Name: DRd (Daratumu­mab + Revli­mid® + dexamethasone)

DRd (Daratumu­mab + Revli­mid® + dexamethasone) is an Immunotherapy Regimen for Multiple Myeloma (MM)

How does DRd work?
Each of the medications in DRd is designed to kill or slow the growth of myeloma cells. DRd may also work to enhance your immune system to help kill myeloma cells.

D – Daratumumab (Darzalex®)
R – Revlimid® (lenalidomide)
d – Dexamethasone (Decadron®)

Alternative names: DLd, Dara-Rev-dex, Dara-Len-dex

Goals of therapy:
DRd is not given to cure multiple myeloma, but may lead to a complete remission in some patients. DRd is given to slow the progression of myeloma and to decrease symptoms from the disease.

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Schedule

  • Daratumumab intravenous infusion on Days 1, 8, 15, and 22 of Cycles 1 and 2, then Days 1 and 15 of Cycles 3 through 6, then monthly thereafter. The time of infusion varies depending upon the tolerability and number of previous infusions
  • Lenalidomide 25 mg by mouth daily for 21 days continuously on Days 1 - 21
  • Dexamethasone:
    • 40 mg (ten 4 mg tablets) by mouth on Days 1, 8, 15, and 22
      OR
    • 20 mg (five 4 mg tablets) by mouth on Days 1, 8, 15, and 22
  • Premedications for DRd commonly include acetaminophen (Tylenol) 650 – 1000 mg, diphenhydramine (Benadryl) 25 – 50 mg, and dexamethasone (See ChemoExperts tips section for how to take dexamethasone on treatment days)

Estimated total infusion time for this treatment:

  • Cycle 1 Day 1 may take up to 8 hours because of the possibility of experiencing infusion reactions with daratumumab and be given in a hospital, or near-hospital setting. If you do not experience any infusion reactions with the first infusion, Cycle 1 Day 8 (the second infusion) may take from 4 to 6 hours. If you do not experience any infusion reactions during the first two infusions of daratumumab, the infusion time on remaining doses may take only 3 to 4 hours
  • 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

Lenalidomide is a human teratogen. In order to decrease the risk of embryo-fetal exposure, lenalidomide is available only through a restricted distribution program (Revlimid® REMS).

DRd is usually given in an outpatient infusion center, allowing the person to go home afterwards. It is repeated every 28 days. This is known as one Cycle. Each cycle may be repeated until the regimen no longer works or until unacceptable side effects occur.

Click here for the common DRd immunotherapy 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 DRd immunotherapy side effects are shown here. Side effects sometimes have percentage ranges [example: 59 – 84%] because they differed between clinical studies:

  • Low white blood cells (59 - 84%)
  • Cough (29 - 50%)
  • Diarrhea (43 - 44%)
  • Muscle spams (26 - 44%)
  • Fatigue (34 - 35%)
  • Upper respiratory tract infection (25 - 32%)
  • Increased bleeding risk [low platelet count; thrombocytopenia] (27 - 31%)
  • Anemia [low red blood cells] (25 - 31%)
  • Fever (20 - 31%)
  • Constipation (29%)
  • High blood pressure (28%)
  • Nausea, mostly mild (24 - 28%)
  • Fluid retention in extremities such as legs (15 - 25%)
  • Sore throat or sinus infection (24%)
  • Trouble sleeping (19%)
  • Shortness of breath (18%)
  • Back pain (18%)
  • Vomiting (17%)
  • Weakness (16%)
  • Pneumonia (14%)
  • Neutropenic fever (6%)

Approximately 7 - 15% of patients discontinued DRd therapy due to unacceptable side effects.

Side effect videos Side Effect Videos
DiarrheaDiarrheaFatigue Fatigue AnemiaAnemiaConstipationConstipationNausea and VomitingNausea and VomitingPainPainNeutropenic FeverNeutropenic FeverBleedingBleeding

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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 DRd as planned, delay treatment, change drug doses, or switch therapy.

Red blood cell transfusions may be recommended for periods of moderate to severe anemia.

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ChemoExperts Tips

  • The first dose of daratumumab may be given in the hospital setting due to the possibility of infusion reactions as described in the Side Effects section above
  • Approximately 50% of patients experience an infusion reaction, which most commonly occur during the first dose of daratumumab (infusion reactions during subsequent [later] doses are less likely). Acetaminophen (Tylenol®) and an antihistamine such as diphenhydramine (Benadryl®) will be given approximately one hour before each dose to decrease the chance of an infusion reaction
  • On days daratumumab is given, your doctor may instruct you to take half of your dexamethasone dose (20 mg) before your infusion then 20 mg after the infusion
  • 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
  • Therapy with daratumumab 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 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 six months after completing therapy. Before your first infusion, you will have a 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 transfusions 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
  • Additional medications that may be prescribed include Bactrim® (Sulfamethoxazole/Trimethoprim) to prevent Pneumocystis Jirovecii Pneumonia (PJP), and omeprazole (or a similar medication) to prevent ulcers from dexamethasone
  • 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 DRd (Daratumu­mab + Revli­mid® + 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 DRd (Daratumu­mab + Revli­mid® + dexamethasone). Depending upon your income, they may be able to help cover the cost of:

  • Daratumumab
  • Revlimid®
  • 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 DRd (Daratumu­mab + Revli­mid® + 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 DRd (Daratumu­mab + Revli­mid® + 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.

Revlimid® (Lenalidomide)

  • Revlimid ​Is a capsule
  • Is not to be used during pregnancy; it may cause human embryo toxicity and birth defects. Females must avoid pregnancy while taking this and for 4 weeks after finishing therapy 
  • Is only available through the R.E.M.S. program, which is Risk Evaluation and Mitigation Strategy http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm 
  • Women should not breast feed while on this drug
  • Can cause severe low white blood cells and platelet cell counts. Patients who have “del 5q myelodysplastic syndromes” should have complete blood counts (CBC) monitored every week for the first eight weeks of treatment
  • Patients may require dose decreases and periodic stopping of doses for low blood cell counts, poor kidney function, or other reasons
  • Some patients may require growth factors to help stimulate blood cell production
  • Patients are at increased risk of blood clots in limbs (DVT- deep vein thrombosis) or lungs (PE- pulmonary embolism), as well as risk for heart attack and stroke.  A "blood thinner" such as aspirin or warfarin may be prescribed to decrease risk of clots
  • Is swallowed whole with or without food and with a large glass of water; take at the same time every day
  • If you miss a dose and it’s less than 12 hours late, take the dose.  If it’s more than 12 hours late skip the dose.  Do not take two doses at the same time
  • This capsule contains lactose.  Patients should advise their physician if they are lactose intolerant
  • Do not open capsules.  If powder from capsule touches skin, wash immediately with soap and water
  • Should be stored at controlled room temperature
  • May interact with digoxin, estrogen containing therapies, and erythropoietin
  • Has been linked to the development of other cancers in a small number of people
  • Do not donate blood during therapy and for one one month after completion of therapy
General Revlimid (Lenalidomide) side effects
  • Low while blood cells
  • Low platelet cells
  • Blood clots
  • Bleeding
  • Diarrhea
  • Constipation
  • Itching
  • Cough or shortness of breath
  • Skin rash
  • Pain
  • Nausea
  • Fatigue, dizziness
  • Muscle cramps
  • Low red blood cells
  • Swelling of arms and legs
  • Liver toxicity
  • Allergic reactions
  • Tumor Lysis Syndrome (TLS)
  • Click on the Revlimid (lenalidomide) package insert below for reported side effects and possible drug interactions

Side Effect Videos
DiarrheaDiarrheaFatigue Fatigue BleedingBleedingConstipationConstipationPainPainAnemiaAnemiaNeutropenic FeverNeutropenic FeverBlood ClotsBlood Clots

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

1) Dimopoulos MA, Oriol A, Nahi H, et al. Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016;375:1319-1331.

2) Plesner T, Arkenau HT, Gimsing P, et al. Phase 1/2 study of daratumumab, lenalidomide, and dexamethasone for relapsed multiple myeloma. Blood. 2016; 128(14):1821-1828.

Created: February 20, 2017 Updated: November 2, 2017

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.

What is a teratogen?

A drug that is known to cause severe birth defects or fetal death. These drugs should NOT be used during pregnancy and patients should avoid becoming pregnant while taking these drugs.

  • Women, if taking a teratogenic medication, should abstain from heterosexual intercourse or use two forms of reliable contraception at least 4 weeks prior to, during, and for 4 weeks after treatment.
  • Men (even after vasectomy), if taking a teratogenic medication, must use a latex or synthetic condom during any sexual contact with women of childbearing potential and must not donate sperm for up to 28 days following discontinuation of therapy.

What is the Revlimid® REMS program?

REMS stands for Risk Evaluation and Mitigation Strategy. This program requires that all patients must sign a Patient-Physician agreement form acknowledging pregnancy risks before starting treatment. If you are female who can get pregnant, you must have 2 negative pregnancy tests before starting Revlimid® and will have pregnancy tests performed periodically throughout treatment. Revlimid® is only dispensed from certain pharmacies and the pharmacy will contact you before every prescription is dispensed. A confidential survey must also be taken every month before Revlimid® can be dispensed.

Common DRd immunotherapy starting doses

  • Daratumumab 16 mg/kg intravenous infusion on Days 1, 8, 15, and 22 of Cycles 1 and 2, then Days 1 and 15 of Cycles 3 - 6, then monthly thereafter. The time of infusion varies depending upon the tolerability and number of previous infusions
  • Lenalidomide 25 mg by mouth daily for 21 days continuously on Days 1 - 21. If kidney function is drcreased (Clcr: 30 – 60 mL/min), the dose of lenalidomide is reduced from 25 mg to 10 mg
  • Dexamethasone (dose may depend upon your doctor’s recommendation):
    • 40 mg (ten 4 mg tablets) by mouth on Days 1, 8, 15, and 22
      OR
    • 20 mg (five 4 mg tablets) by mouth on Days 1, 8, 15, and 22 (if older than 75 years and Body Mass Index < 18.5)

Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability

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

What is a "Serum Protein Electrophoresis," or SPEP?

An antibody, sometimes referred to as an immunoglobulin, is made up of two pieces - 1 heavy chain, and 1 light chain. They are normally attached to one another. Free light chains are fragments, or small parts of antibodies (also known as immunoglobulins) that are found unattached to the heavy chain and can be detected in the blood or urine.

Myeloma cells sometimes produce too many of these antibody chains. The blood test used to detect these extra antibodies or antibody pieces (free light chains) may be referred to as a "Serum Protein Electrophoresis," or SPEP.