Leukemias, lymphomas, and other hematologic cancers:

Indications for: Melphalan Injection

Palliative treatment of multiple myeloma when oral therapy is not appropriate.

Clinical Trials:

  • In a randomized clinical trial, prednisone plus IV melphalan was compared to prednisone plus oral melphalan for the treatment of myeloma. All patients received oral prednisone starting at 0.8 mg/kg/day with doses tapered over 6 weeks. 

  • For the melphalan treatment arms, patients were randomly assigned to receive either oral melphalan 0.15 mg/kg/day x 7 followed by 0.05 mg/kg/day when WBC began to rise; or IV melphalan 16 mg/m2 every 2 weeks x 4 (over 6 weeks) followed by the same dose every 4 weeks.

  • The overall response rates were similar at week 22 between oral and IV melphalan (44% vs 38%, respectively). There were more patients who had a poor-risk classification (58% vs 44%) and high tumor load (51% vs 34%) in the oral arm compared to the IV arm (P <.04).

  • The IV melphalan arm had a higher incidence of severe myelotoxicity (WBC ≤1,000 and/or platelets ≤25,000) vs the oral melphalan arm (28% vs 11%, respectively).

Adult Dosage:

Give by IV infusion over 15–20 minutes. 16mg/m2 every 2 weeks for a total of 4 doses, then at 4-week intervals. Continue treatment as hematological recovery permits. Renal insufficiency (BUN≥30mg/dL): consider reducing dose by 50%.

Children Dosage:

Not recommended.

Melphalan Injection Contraindications:

Prior resistance to melphalan.

Boxed Warning:

Should be administered under the supervision of an experienced physician in cancer chemotherapeutic agents. May cause severe bone marrow suppression with resulting infection or bleeding. Intravenous (IV) form may be more myelosuppressive than oral form. Leukemogenic in humans. Potentially mutagenic.

Melphalan Injection Warnings/Precautions:

Prior irradiation or chemotherapy. Bone marrow suppression. Azotemia. Monitor platelets, hemoglobin, WBC and differential at start of therapy and prior to each course; discontinue if WBC <3,000cells/µL or platelets <100,000cells/µL. Moderate to severe renal impairment. Elderly. Pregnancy (Cat.D), nursing mothers: not recommended.

See Also:

Melphalan Injection Classification:

Alkylating agent.

Melphalan Injection Interactions:

Radiotherapy potentiates antineoplastic effect. For IV: caution with cyclosporine, cisplatin, BCNU, nalidixic acid.

Adverse Reactions:

Bone marrow suppression, GI upset, hepatic dysfunction, anemia, blood dyscrasias, secondary malignancies (eg, nonlymphocytic leukemia), rash, alopecia, pulmonary fibrosis, interstitial pneumonitis, gonadal toxicity (amenorrhea, infertility); hypersensitivity reactions, cardiac arrest (rare).

Note:

Formerly known under the brand name Alkeran.

Drug Elimination:

Following injection, the terminal elimination phase half-life was approximately 75 minutes.

How Supplied:

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