Multiple Myeloma Vitamin C

Multiple Myeloma Vitamin C

Overview | Schedule | Side Effects | Monitoring | Tips | Patient Assistance | Emotional Wellness | Drugs | References

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Treatment Name: RVd (Revlimid®­ + Velcade®­ + dexametha­sone)

RVd (Revlimid®­ + Velcade®­ + dexametha­sone) is a Chemotherapy Regimen for Multiple Myeloma (MM)

How does RVd work?
Each of the medications in the RVd regimen is designed to kill or slow the growth of myeloma cells.

R - Revlimid® (lenalidomide)
V - Velcade® (bortezomib)
d - dexamethasone (Deltasone, dex)

Alternative name: VRd

V - Velcade® (bortezomib)
R - Revlimid® (lenalidomide)
d - dexamethasone (Deltasone, dex)

Goals of therapy:
RVd or VRd is given to alleviate myeloma symptoms and slow the progression of multiple myeloma, not to cure this disease. After treatment, patients who respond to RVd typically are either monitored, continue on to maintenance therapy, or proceed to bone marrow transplant.

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Schedule

• Lenalidomide (Revlimid®) 25 mg by mouth daily for 14 days continuously on Days 1 - 14
• Bortezomib subcutaneous injection on Days 1, 4, 8, and 11
• Dexamethasone:
  • 40 mg (ten 4 mg tablets) by mouth on Days 1, 8, and 15
    Or
  • 20 mg (five 4 mg tablets) by mouth on Days 1, 2, then 4, 5, then 8, 9, then 11, 12

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)

Bortezomib is usually given in an outpatient infusion center, allowing the person to go home afterwards. Lenalidomide and dexamethasone are usually taken at home.

RVd is repeated every 21 days. This is known as one Cycle. Each cycle may be repeated up to eight times, depending upon the stage of the disease. Duration of therapy may last up to 8 months, depending upon response, tolerability, and number of cycles prescribed.

Click here for common RVd 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 side effects with RVd are shown here:

• Tingling in fingers or toes (53%)
• Fatigue (50%)
• Low white blood cells (42%)
• Diarrhea (41%)
• Muscle pain (39%)
• High blood sugar (38%)
• Fluid accumulation (34%)
• Increased bleeding risk [Low platelets] (33%)
• Constipation (30%)
• Trouble sleeping (28%)
• Anemia [low red blood cells] (23%)
• Nausea (23%)
• Nerve pain (17%)
• Loss of feeling in fingers or toes (14%)
• Rash (14%)
• Dizziness (14%)

Approximately 5 - 19% of patients discontinue RVd due to unacceptable side effects.

Side effect videos
Fatigue Diarrhea Pain Bleeding Anemia Constipation Nausea and Vomiting

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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), plus any others your doctor may order.

How often is imaging needed?
Imaging may be checked before treatment and then periodically during treatment to assess how the chemotherapy is working. Imaging may include: bone surveys, computerized tomography (CT) scans, magnetic resonance imaging (MRI), or positron emission tomography (PET) scans.

How might blood test results affect treatment?
Depending upon the results, your doctor may advise to continue chemotherapy as planned, or delay or switch therapy.

Questions to Ask Your...

A better understanding of your treatments will allow you to ask more questions of your healthcare team. We then hope that with the answers, you will get better results and have greater satisfaction with your care. Because we know it's not always easy to know what questions to ask, we've tried to make it easy for you!

Choose any healthcare provider below to see common questions that you may want to ask of this person. Then, either print each list to bring to your clinic visits, or copy the questions and send them as a message to your healthcare team through your electronic medical record.

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ChemoExperts Tips

• Bortezomib can cause reactivation of herpes (HSV- herpes simplex virus) or varicella zoster virus (VZV), which causes shingles.  Prophylactic (preventative) anti-viral medications such as acyclovir (Zovirax®), valacyclovir (Valtrex®), or famciclovir (Famvir®) should be taken during treatment
• Additional medications that may be prescribed include Bactrim® (Sulfamethoxazole/Trimethoprim, unless you have a sulfa allergy) to prevent Pneumocystis Pneumonia and omeprazole (Prilosec®, or a similar medication in that drug class) 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 RVd (Revlimid®­ + Velcade®­ + 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 RVd (Revlimid®­ + Velcade®­ + dexametha­sone). Depending upon your income, they may be able to help cover the cost of:

• Revlimid®
• 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 RVd (Revlimid®­ + Velcade®­ + 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 RVd (Revlimid®­ + Velcade®­ + dexametha­sone)

Individual Drug Label Information

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 Strategyhttp://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
Diarrhea Fatigue Bleeding Constipation Pain Anemia Neutropenic Fever Blood Clots

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
Diarrhea Fatigue Bleeding Constipation Pain

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.

References

1. Kumar S, Flinn I, Richardson PG, et al. Randomized, multicenter, phase 2 study (EVOLUTION) of combinations of bortezomib, dexamethasone, cyclophosphamide, and lenalidomide in previously untreated multiple myeloma. Blood. 2012;119:4375-4381.

2. Richardson, PG, Xie W, Jagannath S, et al. A phase 2 trial of lenalidomide, bortezomib, and dexamethasone in patients with relapsed and relapsed/refractory myeloma. Blood. 2014;123:1461-1469.

Created: September 8, 2015 Updated: September 10, 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 Revised International staging system (R-ISS) for multiple myeloma. The type and effectiveness of the treatment may depend upon the stage and whether prior treatments have been tried.

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 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.

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 risks with pregnancy before starting treatment.

If you are woman who can get pregnant, you must have 2 negative pregnancy tests before starting lenalidomide (Revlimid®) and will have pregnancy tests performed periodically throughout treatment. Lenalidomide 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 lenalidomide can be dispensed.

Clinical Studies

If you are interested in reading the clinical trials results, please click on references below:

1. Kumar S, Flinn I, Richardson PG, et al. Randomized, multicenter, phase 2 study (EVOLUTION) of combinations of bortezomib, dexamethasone, cyclophosphamide, and lenalidomide in previously untreated multiple myeloma. Blood. 2012;119:4375-4381.

2. Richardson, PG, Xie W, Jagannath S, et al. A phase 2 trial of lenalidomide, bortezomib, and dexamethasone in patients with relapsed and relapsed/refractory myeloma. Blood. 2014;123:1461-1469.

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 status,2) 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

Common Starting Doses

• Lenalidomide 25 mg by mouth daily for 14 days continuously, Days 1 - 14
• Bortezomib 1.3 mg/m² subcutaneous injection on Days 1, 4, 8, and 11
• Dexamethasone 40 mg (ten 4 mg tablets) by mouth on Days 1, 8, and 15
         OR
• Dexamethasone 20 mg (five 4 mg tablets) by mouth on Days 1, 2, 4, 5, 8, 9, 11, 12

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

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.

Multiple Myeloma Vitamin C

Source: https://www.chemoexperts.com/rvd.html