Combination of Revlimid, Melphalan and Dexamethasone as First Line Treatment for Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Lenalidomide (Revlimid); Melphalan; Dexamethasone
Intervention MeSH terms: Dexamethasone; Lenalidomide; Melphalan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: multiple myeloma; frontline treatment; first-line treatment

Summary:

      This study is to determine whether addition of Revlimid to standard therapy will increase
      overall and complete response rates compared to historical standard frontline therapy and
      whether this combination treatment has fewer side effects than similar combination induction
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly Diagnosed multiple myeloma, ISS stage I-III requiring therapy: Serum M-protein
             ≥1 gm/dL (≥10 gm/L), Urine M-protein ≥200 mg/24 hr, Serum FLC assay: involved FLC ≥10
             mg/dL (≥100 mg/L) provided serum FLC ratio is abnormal

          -  Previously untreated except prior treatment with corticosteroid less than one full
             cycle of pulsed dose dexamethasone (40 mg daily days 1-4, 9-12, and 17-20) or
             equivalent is allowed. Concomitant administration of IV bisphosphonates, Zometa
             (zoledronic acid, up to 4 mg IVSS over 30 minutes every four weeks) or Aredia
             (alendronate, up to 90 mg IVSS over 4 hours every four weeks), for prophylaxis against
             skeletal complications due to lytic bone disease or for acute management of
             hypercalcemia is allowed. Concomitant external beam radiation therapy for local
             management of lytic bone disease is allowed.

          -  Age ≥ 18 years old

          -  Life expectancy ≥ 12 weeks

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status will be employed. ECOG
             0-2 accepted.

          -  WBC ≥ 3.0 X 103/ µL, ANC ≥ 1.5 X 103/ µl, Hgb ≥ 8.0 gm/ dL, Plt ≥ 75 X 103/ µl, Serum
             Creatinine ≤ 2.0 mg/ dL

          -  Ability to understand and the willingness to sign a written informed consent document.

          -  All study participants must be registered into the mandatory RevAssist® program, and
             be willing and able to comply with the requirements of RevAssist®.

          -  Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy
             test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again
             within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7
             days) and must either commit to continued abstinence from heterosexual intercourse or
             begin TWO acceptable methods of birth control, one highly effective method and one
             additional effective method AT THE SAME TIME, at least 28 days before she starts
             taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree
             to use a latex condom during sexual contact with a FCBP even if they have had a
             successful vasectomy. See Appendix A: Risks of Fetal Exposure, Pregnancy Testing
             Guidelines and Acceptable Birth Control Methods.

          -  Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients
             intolerant to ASA may use warfarin or low molecular weight heparin).

        Exclusion Criteria:

          -  Prior therapy with Revlimid®, Thalomid (thalidomide), Velcade (bortezomib), Alkeran
             (melphalan) excluded. Prior therapy with corticosteroid allowed as defined in
             inclusion criteria.

          -  No prior or concurrent treatment with an investigational agent.

          -  Active Hepatitis B or C excluded, New York Heart Association grade III/IV congestive
             heart failure excluded, History of bleeding disorder excluded, History of platelet
             function disorder, History of deep vein thrombosis or other thromboembolic event
             excluded

          -  Prior history of allergic reaction to IMiD™ compounds (Thalidomide, Lenalidomide)
             excluded.

          -  Concomitant treatment with nonsteroidal antiinflammatory drugs (NSAIDs)(with the
             exception of aspirin) or other nephrotoxic agents is excluded.

          -  Serum creatinine > 2.0 mg/ dL is excluded

          -  Pregnancy and breastfeeding excluded

          -  Known HIV+ patients are excluded.

          -  Other active hematologic or solid tumor or history of such disease requiring therapy
             of any form within five years of screening is excluded.