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Treatment Name: Melphalan (Evomela®, Alkeran®)

Melphalan (Evomela®, Alkeran®) is a Chemotherapy Regimen for Autologous Stem Cell Transplant (autoSCT) for Multiple Myeloma

How does Melphalan (Evomela®, Alkeran®) work?
Melphalan is designed to slow the growth of and kill multiple myeloma cancer cells. Melphalan is commonly given as the conditioning regimen for patients with multiple myeloma prior to autologous stem cell transplant.

Goals of therapy:
Melphalan is given to kill residual (left over) multiple myeloma cells, decrease the amount of abnormal blood protein produced by myeloma cells, prevent relapse, and increase survival. Melphalan is not usually given to cure multiple myeloma, but rather to slow the progression of the disease and to improve symptoms of myeloma.

Schedule

  • Melphalan intravenous infusion administered over 15 - 30 minutes as a single daily dose on either a single day or two consecutive days, prior to stem cell transplant
    • either Day -3 and Day -2, OR on Day -2 and Day -1
      OR
    • on Day -1 OR Day -2 only
  • Stem cells are infused on Day 0 ("Day Zero") of transplant
  • Depending upon the institution protocol, the total melphalan dose may be administered over 1 or 2 days

Estimated total infusion time for this treatment:

  • Up to 30 minutes for each infusion
  • 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. Premedications often include dexamethasone, diphenhydramine, ondansetron, and ranitidine

A hospital stay may be required:
Melphalan may require a 14 to 21-day hospital stay (or sometimes longer), depending upon bone marrow function recovery and how well the side effects of treatment are tolerated. Patients who are fit may receive this type of stem cell transplant on an outpatient basis with close monitoring in clinic.

Click here for common melphalan doses for autologous stem cell transplant.

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 of melphalan are shown here. Side effects sometimes have percentage ranges [example: 41 - 73%, neutropenic fever] because they differed between clinical studies:

Note: Patients older than 65 years are at higher risk for mouth sores (45%) compared to those who are younger (23%). Diarrhea may also be more common in elderly patients.

Side effect videos Side Effect Videos
DiarrheaDiarrheaNausea and VomitingNausea and VomitingNeutropenic FeverNeutropenic FeverFatigue Fatigue AnemiaAnemiaConstipationConstipationPainPainBleedingBleedingHair LossHair LossBlood ClotsBlood Clots

Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before treatment, then daily or every other day for the first few weeks while in the hospital, and then periodically after hospital discharge. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), magnesium, phosphorus, blood cultures, plus any others your doctor may order.

How often is imaging needed?
Imaging may be checked before treatment to assess the status of myeloma prior to transplant, or if there is a concern for an infection or blood clot, or whenever clinically indicated. Imaging may include: positron emission tomography (PET scan), computerized tomography (CT), an ECG (or "EKG"), bone scans, or magnetic resonance imaging (MRI). A chest x-ray or chest CT scan may be needed if an infection such as pneumonia is suspected during hospitalization. An ultrasound may be performed to evaluate for formation of a clot during treatment. An EKG may be recommended if you feel a very fast heartbeat to look for atrial fibrillation.

How might blood test results/imaging affect treatment?
Daily or every other day labs will indicate bone marrow recovery after transplant. White blood cell recovery known as white blood cell engraftment typically occurs day 10 to day 14 after stem cell infusion depending upon whether growth factors support agents such as filgrastim (Neupogen®) were used. During this time mouth sores tend to heal, nausea and vomiting decrease, antimicrobial prevention agents are discontinued and the patient is prepared for discharge in the following days.

ChemoExperts Tips

  • Melphalan chemotherapy and stem cell transplant may require a long stay in the hospital. Try to be as active as possible by taking walks in the hallway, or using an exercise bicycle in the room, if available. This will hopefully speed time to recovery
  • Antibiotics, antifungal agents, and antiviral medications are commonly used to prevent infection. The particular medications and schedules used may vary between institutions. Be sure to tell your doctor if you experience discomfort anywhere as this may be a clue to an infection
  • A medication known as Bactrim® (Septra®, TMP/SMX) is commonly taken to prevent a certain type of pneumonia known as pneumocystis carinii. If you are allergic to sulfa antibiotics, a different medication other than Bactrim® may be prescribed
  • Recombinant hematopoietic growth factors such as granulocyte-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) are frequently administered to patients following stem cell transplant in order to speed up white blood cell recovery and shorten duration of hospitalization
  • Nausea and vomiting are major side effects associated with melphalan chemotherapy and may last for a couple of weeks after chemotherapy is given. Tell your doctors how you are feeling. Your healthcare team may be able to administer several anti-nausea medications around the clock to reduce nausea
  • Melphalan chemotherapy may result in the development of painful mouth sores and difficulty eating. Your team may increase pain medication regimen and if needed administer nutrition intravenously also known as Total Parenteral Nutrition (TPN)
  • Some patients chew on ice for up to 30 minutes before the melphalan infusion, during the infusion, and 30 minutes after melphalan is done infusing
  • Tell your doctor if you experience any new rash, bleeding, fever, cough, weight loss, or new lumps or bumps
  • If you take oral cyclosporine regularly, your cyclosporine may need to be temporarily stopped while receiving melphalan to prevent kidney problems
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for 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 Melphalan (Evomela®, Alkeran®), 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 Melphalan (Evomela®, Alkeran®). Depending upon your income, they may be able to help cover the cost of:

  • Melphalan

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 Melphalan (Evomela®, Alkeran®) 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 Melphalan (Evomela®, Alkeran®)

Individual Drug Label Information

Melphalan (Evomela®, Alkeran®)

  • Melphalan is an intravenous (I.V.) infusion that is typically given over 15 - 30 minutes
  • Patients who experience a hypersensitivity reaction to melphalan should have the infusion stopped immediately and not receive further doses. A hypersensitivity reaction may result in itching, swelling, rash, fast heart beat, low blood pressure, or difficulty breathing
  • Dosage adjustments may be required for decreased renal function
  • Special care should be taken if melphalan is administered into a peripheral I.V. line due to the risk of the drug leaking out into the tissue (skin or muscle) and causing damage. This is known as extravasation. Unless peripheral veins are adequate, melphalan should be given into an injection port, or central venous line, such as a P.I.C.C line (Peripherally Inserted Central Catheter)
  • May cause suppression of ovary function resulting in menopause and end of periods in premenopausal women
  • May cause reversible or irreversible function of testicular function in men
  • Women of child-bearing potential should be advised to avoid becoming pregnant while receiving melphalan. If a woman becomes pregnant while receiving melphalan, she should be informed of potential hazards to the unborn baby
  • It is not known if melphalan is excreted in human milk, therefore women who plan to nurse a baby after receiving melphalan should be advised of the risks of breast-feeding
General side effects from Melphalan (Evomela®, Alkeran®)
  • Low red blood cells, white blood cells, or platelets
  • Gastrointestinal side effects such as diarrhea, mouth sores, nausea and upset stomach are common
  • May cause lung problems
  • Although rare, it has been linked to the development of acute leukemia or other cancers 
  • Acute hypersensitivity reactions, including anaphylaxis, were reported in 2.4% of patients
  • Click on the melphalan (Evomela®, Alkeran®) package insert below for reported side effects, possible drug interactions, and other prescribing information

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaHair LossHair LossFatigue Fatigue ConstipationConstipationPainPainAnemiaAnemiaNeutropenic FeverNeutropenic Fever

See DailyMed package insert.

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References

1) Bensinger WI, Becker PS, Gooley TA, et al. A randomized study of melphalan 200 mg/m2 vs 280 mg/m2 as a preparative regimen for patients with multiple myeloma undergoing auto-SCT. Bone Marrow Transplant. 2016;51:67-71.

2) Cunningham D, Paz-Ares L, Milan S, et al. High-dose melphalan and autologous bone marrow transplantation as consolidation in previously untreated myeloma. J Clin Oncol. 1994;12:759-763.

3) Hari P, Aljitawi O, Arce-Lara C, et al. A Phase IIb, Multicenter, Open-Label, Safety, and Efficacy Study of High-Dose, Propylene Glycol-Free Melphalan Hydrochloride for Injection (EVOMELA) for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Transplantation. Biol Blood Marrow Transplant. 2015;21:2100-2105.

4) Jantunen E, Kuttinen T, Pentillä K, et al. High-dose melphalan (200 mg/m2) supported by autologous stem cell transplantation is safe and effective in elderly (>or=65 years) myeloma patients: comparison with younger patients treated on the same protocol. Bone Marrow Transplant. 2006;37:917-922.

5) Sirohi B, Powles R, Mehta J, et al. An elective single autograft with high-dose melphalan: single-center study of 451 patients. Bone Marrow Transplant. 2005;36:19-24.

6) Moreau P. How I treat myeloma with new agents. Blood. 2017;130:1507-1513.

Created: October 14, 2017 Updated: October 14, 2017

What is Autologous Stem Cell Transplant (autoSCT) for Multiple Myeloma?

Autologous stem cell transplant or "bone marrow transplant" is a type of stem cell transplant in which a patient’s own stem cells are collected prior to administration of high-dose chemotherapy, or a combination of high-dose chemotherapy agents, with or without radiation.

High-dose chemotherapy is designed to kill more cancer cells, but it also destroys normal blood-producing cells in the bone marrow. Because of this, previously collected stem cells are infused after high-dose chemotherapy to allow the bone marrow to recover blood cell production faster and can prevent a potentially life-threatening infection from occuring.

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 your therapy.

What is a Conditioning Regimen?

A conditioning regimen is a form of treatment used to prepare a patient for stem cell transplant.

The conditioning regimen is used to make room in the bone marrow for new white blood cells, red blood cells and platelets to grow, helps eliminate or kill any residual cancer cells, and ensures that the body does not reject the newly infused stem cells. It may include chemotherapy, monoclonal antibody therapy, total body irradiation, or a combination of these.

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.

Common melphalan doses for autologous stem cell transplant for multiple myeloma

  • Melphalan 140 mg/m2 or 200 mg/m2 intravenous infusion administered over 15 - 30 minutes as a single daily dose on either one day or two consecutive days prior to stem cell transplant
    • either Day -3 and Day -2, OR on Day -2 and Day -1
      OR
    • on Day -1 OR Day -2 only
  • Stem cells are infused on Day 0 ("Day Zero") of transplant
  • Depending upon the institution protocol, the total melphalan dose may be administered over 1 or 2 days
  • Dose reductions may be considered in patients with kidney dysfunction
  • Mouth sores may be more common when the dose is split over two days vs. given all on one day
  • Melphalan 140 mg/m2 may be used in patients 70 years or older
  • Melphalan 280 mg/m2 is often given with amifostine, a medication used to prevent gastrointestinal and kidney side effects

Clinical Studies

1) Bensinger WI, Becker PS, Gooley TA, et al. A randomized study of melphalan 200 mg/m2 vs 280 mg/m2 as a preparative regimen for patients with multiple myeloma undergoing auto-SCT. Bone Marrow Transplant. 2016;51:67-71.

2) Cunningham D, Paz-Ares L, Milan S, et al. High-dose melphalan and autologous bone marrow transplantation as consolidation in previously untreated myeloma. J Clin Oncol. 1994;12:759-763.

3) Hari P, Aljitawi O, Arce-Lara C, et al. A Phase IIb, Multicenter, Open-Label, Safety, and Efficacy Study of High-Dose, Propylene Glycol-Free Melphalan Hydrochloride for Injection (EVOMELA) for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Transplantation. Biol Blood Marrow Transplant. 2015;21:2100-2105.

4) Jantunen E, Kuttinen T, Pentillä K, et al. High-dose melphalan (200 mg/m2) supported by autologous stem cell transplantation is safe and effective in elderly (>or=65 years) myeloma patients: comparison with younger patients treated on the same protocol. Bone Marrow Transplant. 2006;37:917-922.

5) Sirohi B, Powles R, Mehta J, et al. An elective single autograft with high-dose melphalan: single-center study of 451 patients. Bone Marrow Transplant. 2005;36:19-24.

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 does Engraftment mean?

Engraftment is when the new blood-producing cells start to multiply in the bone marrow and begin to appear the blood. White blood cell engraftment usually occurs first, prior to platelet or red blood cell engraftment, and is associated with the healing of mouth sores, resolution or abatement of nausea and neutropenic fever. Patients can go home from the hospital soon after engraftment occurs.

What is Total Parenteral Nutrition (TPN)?

Total Parenteral Nutrition (TPN) is the process of administering a type of liquid nutrition intravenously, bypassing the normal process of food digestion in stomach and gastrointestinal tract. It frequently consists of glucose, lipids, amino acids, electrolytes, vitamins, and minerals and is given to people who cannot eat due to mucositis or cannot absorb nutrients due to inflammation of the colon.

TPN often has a milky white appearance and is prepared in a large bag (1 to 3 liters)

Exercise Bicycle

What if a bicycle is not available? Some hospitals allow family members to purchase an exercise bicycle and bring it in fully assembled. Ask your nurse if this may be an option!

What is Atrial Fibrillation?

Atrial fibrillation, or “Afib,” is when part of your heart, the atria, beats abnormally fast. A fast heart rate can sometimes be felt. This may be referred to as a palpitation. Afib can lead to low blood pressure, shortness of breath, lightheadedness or dizziness.

Afib may also increase the risk of a blood clot forming. Blood clots may be life threatening, especially if they occur in the brain, lungs, or a blood vessel leading to the heart. If you develop these symptoms, seek emergency care immediately.