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Treatment Name: Isa-Pd (Isatuximab + Pomalidomide + Dexamethasone)

Isa-Pd (Isatuximab + Pomalidomide + Dexamethasone) is a Treatment Regimen for Multiple Myeloma (MM)

How does Isa-Pd for multiple myeloma work?

Isatuximab is an antibody (a type of targeted drug therapy) that attaches to a specific protein commonly found on the surface of myeloma cells. When isatuximab binds to this protein on myeloma cells it marks the cell for destruction by your immune system.

Pomalidomide and dexamethasone are designed to kill or slow the growth of mutliple myeloma cells.

IsaIsatuximab (Sarclisa®)
PPomalyst® (Pomalidomide)
dDexamethasone (Decadron®)

  • Alternative names: Isa/Pom/Dex, Isa + Pom/Dex, or Isa-Pom-Dex

Goals of Isa-Pd therapy:

Isa-Pd is typically given to patients who have had at least two prior therapies, including lenalidomide (Revlimid®) and a proteasome inhibitor (bortezomib, carfilzomib, or ixazomib). It is not usually given to cure multiple myeloma, but rather to slow the progression of the disease and to improve symptoms of myeloma.

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How is Isa-Pd therapy for multiple myeloma given?

  • Isatuximab is an intravenous (I.V.) infusion given every week for 4 weeks (Days 1, 8, 15, 22) during Cycle 1, then every 2 weeks thereafter for all subsequent cycles (Days 1 and 15)
  • Usual pomalidomide starting dose: 4 mg oral capsule by mouth once daily for 21 consecutive days (days 1 through 21 of each cycle), followed by 7 days off (Days 22 through 28 of each cycle) where pomalidomide is NOT taken
  • Usual dexamethasone starting dose: 40 mg (ten 4 mg oral tablets) by mouth once weekly (Days 1, 8, 15, and 22 of each cycle)
    • For patients 75 years or older, typical starting dose is 20 mg (five 4 mg oral tablets)
    • Dexamethasone may also be given via I.V. infusion instead of by mouth

Estimated total infusion time for Isatuximab (Sarclisa®) treatment:

  • Up to 4 hours for Cycle 1, Day 1; then as short as 2 hours each following day isatuximab is given, if well tolerated
  • 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

Of note: Pomalidomide is a human teratogen. In order to decrease the risk of embryo-fetal exposure, pomalidomide is available only through a restricted distribution program (Pomalyst® REMS).

  • Isatuximab is usually given in an outpatient infusion center, allowing the person to go home afterwards. Pomalidomide and dexamethasone are usually taken at home.
  • Isa-Pd is repeated every 28 days. This is known as one Cycle. Each cycle may be repeated until the treatment no longer works or until unacceptable side effects occur. Duration of therapy depends upon response, tolerability, and number of cycles prescribed.

Click here for the common Isa-Pd starting doses.

Side Effects

What are the most common side effects from Isa-Pd for multiple myeloma?

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 ISA-Pd clinical studies, the most commonly reported side effects are shown here:

  • Low red blood cells [anemia] (99%)
  • Low white blood cells [neutropenia] (%)
  • Low platelets [thrombocytopenia] (84%)
  • Infusion reactions (38%)
  • Upper respiratory infection (28%)
  • Diarrhea (26%)
  • Lung inflammation (20-24%)
  • Fatigue (17%)
  • Back pain (16%)
  • Constipation (16%)
  • Weakness (15%)
  • Shortness of breath (15%)
  • Nausea (15%)
  • Secondary cancers (4%)

On average, 7% of patients discontinue Isa-Pd treatment due to unacceptable side effects.

Watch videos on common Isa-Pd therapy side effects below

Side effect videos Side Effect Videos
AnemiaAnemiaDiarrheaDiarrheaFatigue Fatigue PainPainConstipationConstipationNausea and VomitingNausea and Vomiting

Monitoring

How often is monitoring needed with Isa-Pd?

Labs (blood tests) may be checked before the start of each cycle or more often at the discretion of your doctor. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), common multiple myeloma labs, plus any others your doctor may order.

How often is imaging needed with Isa-Pd?

Imaging may be checked if there is concern for disease progression or certain side effects. Imaging may include: X-rays, magnetic resonance imaging (MRI), computerized tomography (CT) scans, or positron emission tomography (PET) scans.

How might blood test results/imaging affect treatment with Isa-Pd?

Depending upon the results, your doctor may advise to continue Isa-Pd as planned, reduce the dose of future treatments, delay treatment until the side effect goes away, or switch to an alternative therapy.

ChemoExperts Tips

What are the 7 most important things to know about Isa-Pd while receiving therapy?

  • Infusion reactions with the first dose of isatuximab is fairly common. Approximately 38% of patients (38 out of 100) experience an infusion reaction during the first dose of isatuximab. It is important to know that infusion reactions during subsequent [later] doses are less likely. Acetaminophen (Tylenol®) and antihistamines such as diphenhydramine (Benadryl®) and famotidine (Pepcid®) are given approximately 15 to 60 minutes before each dose to decrease the chance of an infusion reaction
  • Secondary malignancies, or a second and different type of cancer have been reported in roughly one in 25 patients (4%) who have taken isatuximab. The most common types of secondary malignancies include skin squamous cell carcinoma, breast angiosarcoma, and myelodysplastic syndrome (MDS). If you develop a secondary malignancy while on therapy with Isa-Pd, your doctor will determine if its safe to continue with treatment or if your treatment regimen should be changed.
  • Isatuximab 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 isatuximab if any blood transfusions are planned
  • Isatuximab 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 isatuximab
  • Additional medications that may be prescribed during Isa-Pd therapy include Bactrim® (Sulfamethoxazole/Trimethoprim) to prevent Pneumocystis Jirovecii Pneumonia (PJP), and omeprazole (or a similar medication) to prevent stomach ulcers from dexamethasone
  • Before starting Isa-Pd therapy, a pharmacist should ALWAYS review your entire 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 Isa-Pd (Isatuximab + Pomalidomide + 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 Isa-Pd (Isatuximab + Pomalidomide + Dexamethasone). Depending upon your income, they may be able to help cover the cost of:

  • Isatuximab
  • Pomalidomide
  • 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 Isa-Pd (Isatuximab + Pomalidomide + 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 Isa-Pd (Isatuximab + Pomalidomide + Dexamethasone)

Individual Drug Label Information

Isatuximab (Sarclisa®)

  • ​Is an intravenous infusion
  • Acetaminophen (Tylenol®) and antihistamines such as diphenhydramine (Benadryl®) and famotidine (Pepcid®) will be given approximately 15 to 60 minutes before each dose to decrease the chance of an infusion reaction
  • Secondary malignancies, though rare (4%), have been reported. The most common types of secondary malignancies include skin squamous cell carcinoma, breast angiosarcoma, and myelodysplastic syndrome (MDS).
  • Isatuximab 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 isatuximab if any blood transfusions are planned
  • Isatuximab 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 isatuximab
  • May cause fetal harm if given to pregnant patients. Females should use effective contraception during treatment and for at least 5 months after completing treatment. Women should not breast feed while receiving treatment with isatuximab
General side effects from isatuximab
  • Low red blood cells, white blood cells, and platelets
  • Infusion reactions
  • Upper respiratory infection
  • Diarrhea or constipation
  • Lung inflammation
  • Fatigue and weakness
  • Back pain
  • Shortness of breat
  • Click on the isatuximab (Sarclisa®) package insert below for reported side effects, possible drug interactions, and other isatuximab prescribing information

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue ConstipationConstipationPainPainAnemiaAnemia

See DailyMed package insert.

Pomalidomide (Pomalyst®)

  • Pomalidomide is an oral capsule available in 1 mg, 2 mg, 3 mg, and 4 mg strengths 
  • Can be taken on an empty stomach with a large glass of water. Do not eat two hours before and until two hours after taking a dose. Swallow capsule whole and do not break, open, or chew 
  • If you miss a dose, take it as soon as possible ONLY if it is within 12 hours since the dose should have been taken, then return to the normal schedule. If it is already been past 12 hours since the dose should have been taken, do not take the dose. Wait until your next dose is due 
  • Store at room temperature 
  • Dosage adjustments may be required for liver function, low platelets, or low white blood cells 
  • May interact with certain antifungal and seizure medications. Ask your doctor or pharmacist to review your medications for any possible interactions 
  • May interact with grapefruit and grapefruit juice causing increased blood levels of pomalidomide. This could increase your risk of experiencing side effects. Avoid eating grapefruit and drinking anything containing grapefruit juice during treatment 
  • Avoid therapy with St. Johns Wort as it will decrease blood levels of pomalidomide. This could decrease the effectiveness of pomalidomide 
  • Smoking while on therapy with pomalidomide may reduce its effectiveness. Talk to your doctor or pharmacist about smoking cession and available nicotine replacement therapies 
General Pomalidomide (Pomalyst) Side Effects 
  • Low white blood cells and platelets are common during therapy. Your dose of pomalidomide may need to be adjusted to held for a period of time 
  • Pomalidomide causes a higher chance of developing a blood clot, especially when used with dexamethasone. An “blood thinner” such as aspirin or warfarin may be used to decrease the risk of a clot forming 
  • Nerve pain in hands or feet may occur. Tell your doctor if you are experiencing these symptoms  
  • Although rare, pomalidomide may increase your risk of developing secondary cancers such as myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML)  
  • Click on the pomalidomide (Pomalyst) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue 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) Attal M, Richardson PG, Rajkumar SV, et al. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet 2019;394:2096-2107

Created: March 18, 2020 Updated: March 18, 2020

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, 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
  • Males (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.

Common starting doses for Isa-Pd

  • Isatuximab 10 mg/kg intravenous (I.V.) infusion every week for 4 weeks (Days 1, 8, 15, 22) during Cycle 1, then every 2 weeks thereafter for all subsequent cycles (Days 1 and 15)
  • Usual pomalidomide starting dose: 4 mg oral capsule by mouth once daily for 21 consecutive days (days 1 through 21 of each cycle), followed by 7 days off (Days 22 through 28 of each cycle) where pomalidomide is NOT taken
  • Usual dexamethasone starting dose: 40 mg (ten 4 mg oral tablets) by mouth once weekly (Days 1, 8, 15, and 22 of each cycle)
    • For patients 75 years or older, typical starting dose is 20 mg (five 4 mg oral tablets)
    • Dexamethasone may also be given via I.V. infusion instead of by mouth

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 labs are used to monitor multiple myeloma?

Commonly used labs to diagnose and monitor for treatment response in patients with multiple myeloma may include:

Serum Protein ElectroPhoresis (SPEP)
- Serum Immunofixation Electrophoresis (IFE)
- Lactate DeHydrogenase (LDH)
- Serum Free Light Chains (FLC)
- Quantitative immunoglobulins
- Beta 2-microglobulin (B2M)
- Cytogenetic analysis (karyotyping and FISH testing)

Note: Some labs may not apply. In addition, some labs are checked only at diagnosis, while others are used to assess response to treatment.