UNDERSTANDING
YOUR MULTIPLE
MYELOMA LAB TESTS

Woman tending to flowers.

Stay on top of lab work

Your healthcare provider will help you schedule lab tests to track your symptoms and treatment progress. It’s important that you familiarize yourself with the different advanced lab tests and understand what your results mean.

Man and woman on the beach.

Lab tests you might need

Blood tests can check for M protein

It can be hard to know if multiple myeloma has returned, because it sometimes does not cause any symptoms. Healthcare providers will use blood tests that check M protein levels to help monitor disease progression.

 

Illustration of a blood vessel. Inside the vessel there are platelets, white blood cells, and red blood cells.


Complete blood count (CBC)

A CBC measures the number of blood cells you have, including red blood cells, white blood cells, and platelets. Myeloma plasma cells can cause low blood counts because they overgrow and crowd out normal cells in the bone marrow. Monitoring blood cell counts can be used to track disease progression and treatment effects.

Illustration of blood in a test tube. A blood sample is taken for a blood chemistry profile.


Blood chemistry profile

A blood chemistry profile measures the levels of different substances in your blood. These levels provide insight to the function of different organs (kidney, liver, etc) that can be affected by multiple myeloma and treatments.

Normal albumin vs an M spike with multiple myeloma.


Serum protein electrophoresis (SPEP)

Antibodies are part of your immune system and help your body fight infection. They are produced by healthy plasma cells. In multiple myeloma, one plasma cell becomes cancerous and makes multiple copies of itself (clones). Each copy makes an abnormal antibody called M protein. A test called SPEP is used to separate and identify the presence of M protein in the blood. When M protein is detected, it is called an M spike.

The UPEP test estimates the quantity of certain proteins in your urine. The arrow in this UPEP diagram corresponds to the M spike (M protein). The normal UPEP range is ≤500 mg/24 hours for asymptomatic patients.

Illustration of an M spike.


Urine protein electrophoresis (UPEP)

The UPEP test estimates the quantity of certain proteins in your urine. The arrow in this UPEP diagram corresponds to the M spike (M protein). The normal UPEP range is ≤500 mg/24 hours for asymptomatic patients.

M spike (myeloma gamma globulin) lab test

The M spike lab test determines the amount of M protein in your blood. The presence of any M spike is abnormal because it reflects the presence of an abnormal clone of plasma cells. There is not a normal range for M protein. You may have multiple myeloma if the amount of M protein is ≥30 g/L and/or there are other disease symptoms.

Illustration of an immunoglobulin.


Serum quantitative immunoglobulins (Igs)

A serum quantitative Igs test measures the levels of the major classes of Igs (IgG, IgA, IgM, IgD, and IgE) in the blood and can reveal excessive amounts of any of the Ig types. Immunoglobulins are antibodies that help the body fight infection. Patients with certain types of cancer, such as multiple myeloma, may have high amounts of Igs.

 

Serum immunofixation (IFE) image.


Serum immunofixation (IFE)

Different antibody classes of Igs in blood are identified using an IFE. If the presence of an M protein excess is identified by the Serum protein electrophoresis (SPEP) test, IFE will determine what subtype of M protein is present. Too much of 1 type of Ig is usually tied to specific types of blood cancer.

Illustration of immunoglobulin heavy chain and light chain.


Serum free light chain assay

Igs are made up of smaller units called heavy chains and light chains, which bind together to form whole Igs. The presence of an M protein is consistent with the excess production of 1 type of light chain (kappa or lambda), which is detectable in the blood as a free light chain.

Tests that check for signs of multiple myeloma

X­ray machine.


X-ray/bone survey

The inside of your body is able to be seen using X-ray imaging. The images show the parts of your body in different shades of black and white. Multiple myeloma will cause decreased bone density and appear as “punched-out” bone lesions. X-rays can help monitor disease.

MRI machine.


Magnetic resonance imaging (MRI)

Organs and structures inside your body can be imaged using MRI. This technology uses strong magnets and radio waves to create images.

PET-scan machine.


PET scan

PET scan can reveal the locations of cancer cells in different parts of the body using radioactivity. Radioactive glucose is put into your veins, which will be absorbed by cancer cells. Then, a special camera can detect the locations and activity of the cells.

Illustration of a bone marrow biopsy.


Bone marrow biopsy

A bone marrow biopsy may be used to confirm the presence and number of myeloma cells. This test can also be used to detect other blood-related diseases. People with multiple myeloma have too many plasma cells in their bone marrow.

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IMPORTANT SAFETY INFORMATION, INDICATION, AND USAGE

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NINLARO may cause serious side effects, including:

  • Low platelet counts (thrombocytopenia) are common with NINLARO and can sometimes be serious. You may need platelet transfusions if your counts are too low. Tell your healthcare provider if you have any signs of low platelet counts, including bleeding and easy bruising.
  • Stomach and intestinal (gastrointestinal) problems. Diarrhea, constipation, nausea, and vomiting are common with NINLARO and can sometimes be severe. Call your healthcare provider if you get any of these symptoms and they do not go away during treatment with NINLARO. Your healthcare provider may prescribe medicine to help treat your symptoms.
  • Nerve problems are common with NINLARO and may also be severe. Tell your healthcare provider if you get any new or worsening symptoms including: tingling, numbness, pain, a burning feeling in your feet or hands, or weakness in your arms or legs.
  • Swelling is common with NINLARO and can sometimes be severe. Tell your healthcare provider if you develop swelling in your arms, hands, legs, ankles, or feet, or if you gain weight from swelling.
  • Skin Reactions. Rashes are common with NINLARO. NINLARO can cause rashes and other skin reactions that can be serious and can lead to death. Tell your healthcare provider right away if you get a new or worsening rash, severe blistering or peeling of the skin, or mouth sores.
  • Thrombotic microangiopathy (TMA). This is a condition involving blood clots and injury to small blood vessels that may cause harm to your kidneys, brain, and other organs, and may lead to death. Get medical help right away if you get any of the following signs or symptoms during treatment with NINLARO: fever, bruising, nose bleeds, tiredness, or decreased urination.
  • Liver problems. Tell your healthcare provider if you get these signs of a liver problem: yellowing of your skin or the whites of your eyes; pain in your right upper-stomach area.

Other common side effects of NINLARO include low white blood cell counts and bronchitis.

Tell your healthcare provider if you get new or worsening signs or symptoms of the following during treatment with NINLARO:

  • skin rash and pain (shingles) due to reactivation of the chicken pox virus (herpes zoster)
  • blurred vision or other changes in your vision, dry eye, and pink eye (conjunctivitis)

These are not all the possible side effects of NINLARO. Talk to your healthcare provider for medical advice about side effects. You may report side effects to Takeda at 1-844-217-6468 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before taking NINLARO, tell your healthcare provider about all your medical conditions, including if you:

  • have liver problems.
  • have kidney problems or are on dialysis.

  • are pregnant or plan to become pregnant. NINLARO can harm your unborn baby. 

    Females who are able to become pregnant:

    • Avoid becoming pregnant during treatment with NINLARO.
    • Your healthcare provider will do a pregnancy test before you start treatment with NINLARO.
    • You should use effective non-hormonal birth control during treatment and for 90 days after your last dose of NINLARO. If using hormonal contraceptives (for example, birth control pills), you should also use an additional barrier method of contraception (for example, diaphragm or condom). Talk to your healthcare provider about birth control methods that may be right for you during this time.
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with NINLARO.

    Males with female partners who are able to become pregnant:

    • You should use effective birth control during treatment and for 90 days after your last dose of NINLARO.
    • Tell your healthcare provider right away if your partner becomes pregnant or thinks she may be pregnant while you are being treated with NINLARO.
       
  • are breastfeeding or plan to breastfeed. It is not known if NINLARO passes into breast milk, if it affects an infant who is breastfed, or breast milk production. Do not breastfeed during treatment with NINLARO and for 90 days after your last dose of NINLARO.

Taking too much NINLARO (overdose) can cause serious side effects, including death. If you take more NINLARO than instructed by your healthcare provider, call your healthcare provider right away or go to the nearest hospital emergency room right away. Take your medicine pack with you.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements or before starting any new medicines. Talk to your healthcare provider before starting any new medicines during treatment with NINLARO.

Please see Patient Information in the accompanying full Prescribing Information.

What is NINLARO?

NINLARO is a prescription medicine used to treat multiple myeloma in combination with the medicines REVLIMID® (lenalidomide) and dexamethasone, in people who have received at least one prior treatment for their multiple myeloma.

NINLARO should not be used to treat the following people, unless they are participants in a controlled clinical trial:

  • people who are receiving maintenance treatment, or
  • people who have been newly diagnosed with multiple myeloma.

It is not known if NINLARO is safe and effective in children.

IMPORTANT SAFETY INFORMATION FOR NINLARO® (ixazomib)

NINLARO may cause serious side effects, including:

  • Low platelet counts (thrombocytopenia) are common with NINLARO and can sometimes be serious. You may need platelet transfusions if your counts are too low. Tell your healthcare provider if you have any signs of low platelet counts, including bleeding and easy bruising.
  • Stomach and intestinal (gastrointestinal) problems. Diarrhea, constipation, nausea, and vomiting are common with NINLARO and can sometimes be severe. Call your healthcare provider if you get any of these symptoms and they do not go away during treatment with NINLARO. Your healthcare provider may prescribe medicine to help treat your symptoms.
  • Nerve problems are common with NINLARO and may also be severe. Tell your healthcare provider if you get any new or worsening symptoms including: tingling, numbness, pain, a burning feeling in your feet or hands, or weakness in your arms or legs.
  • Swelling is common with NINLARO and can sometimes be severe. Tell your healthcare provider if you develop swelling in your arms, hands, legs, ankles, or feet, or if you gain weight from swelling.
  • Skin Reactions. Rashes are common with NINLARO. NINLARO can cause rashes and other skin reactions that can be serious and can lead to death. Tell your healthcare provider right away if you get a new or worsening rash, severe blistering or peeling of the skin, or mouth sores.
  • Thrombotic microangiopathy (TMA). This is a condition involving blood clots and injury to small blood vessels that may cause harm to your kidneys, brain, and other organs, and may lead to death. Get medical help right away if you get any of the following signs or symptoms during treatment with NINLARO: fever, bruising, nose bleeds, tiredness, or decreased urination.
  • Liver problems. Tell your healthcare provider if you get these signs of a liver problem: yellowing of your skin or the whites of your eyes; pain in your right upper-stomach area.

Other common side effects of NINLARO include low white blood cell counts and bronchitis.

Tell your healthcare provider if you get new or worsening signs or symptoms of the following during treatment with NINLARO:

  • skin rash and pain (shingles) due to reactivation of the chicken pox virus (herpes zoster)
  • blurred vision or other changes in your vision, dry eye, and pink eye (conjunctivitis)

These are not all the possible side effects of NINLARO. Talk to your healthcare provider for medical advice about side effects. You may report side effects to Takeda at 1-844-217-6468 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before taking NINLARO, tell your healthcare provider about all your medical conditions, including if you:

  • have liver problems.
  • have kidney problems or are on dialysis.

  • are pregnant or plan to become pregnant. NINLARO can harm your unborn baby. 

    Females who are able to become pregnant:

    • Avoid becoming pregnant during treatment with NINLARO.
    • Your healthcare provider will do a pregnancy test before you start treatment with NINLARO.
    • You should use effective non-hormonal birth control during treatment and for 90 days after your last dose of NINLARO. If using hormonal contraceptives (for example, birth control pills), you should also use an additional barrier method of contraception (for example, diaphragm or condom). Talk to your healthcare provider about birth control methods that may be right for you during this time.
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with NINLARO.

    Males with female partners who are able to become pregnant:

    • You should use effective birth control during treatment and for 90 days after your last dose of NINLARO.
    • Tell your healthcare provider right away if your partner becomes pregnant or thinks she may be pregnant while you are being treated with NINLARO.
       
  • are breastfeeding or plan to breastfeed. It is not known if NINLARO passes into breast milk, if it affects an infant who is breastfed, or breast milk production. Do not breastfeed during treatment with NINLARO and for 90 days after your last dose of NINLARO.

Taking too much NINLARO (overdose) can cause serious side effects, including death. If you take more NINLARO than instructed by your healthcare provider, call your healthcare provider right away or go to the nearest hospital emergency room right away. Take your medicine pack with you.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements or before starting any new medicines. Talk to your healthcare provider before starting any new medicines during treatment with NINLARO.

Please see Patient Information in the accompanying full Prescribing Information.

What is NINLARO?

NINLARO is a prescription medicine used to treat multiple myeloma in combination with the medicines REVLIMID® (lenalidomide) and dexamethasone, in people who have received at least one prior treatment for their multiple myeloma.

NINLARO should not be used to treat the following people, unless they are participants in a controlled clinical trial:

  • people who are receiving maintenance treatment, or
  • people who have been newly diagnosed with multiple myeloma.

It is not known if NINLARO is safe and effective in children.