Study of Single Agent Lenalidomide in Older Adults With Newly Diagnosed Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Lenalidomide; Prednisone; Dexamethasone
Intervention description: Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle;
Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle;
Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle;
Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle;
Dose Level -4: Discontinue; Starting Dose: 100 mg PO days 1-5 every 28 days;
Dose level -1: 50 mg PO days 1-5 of a 28 day cycle;
Dose level -2: 25 mg PO days 1-5 of a 28 day cycle;
Dose level -3: Discontinue; Starting Dose: 40 mg daily on days 1 - 4 every 28 days;
Dose level -1: 20 mg daily on days 1 - 4 every 28 days;
Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6;
Dose level -2: 10 mg daily on days 1 - 4 every 28 days;
Dose level -3: Discontinue
Intervention MeSH terms: Dexamethasone; Prednisone; Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Newly Diagnosed Standard Risk Multiple Myeloma; Senior Adults

Summary:

      The purpose of this research is to estimate the effectiveness of a response adapted approach
      with the use of the drug, lenalidomide in the treatment of older adults with newly diagnosed
      standard risk multiple myeloma. This means that participants will be given the study drug,
      lenalidomide but depending on how they respond to this drug they may also be given
      dexamethasone and/or prednisone to help with their treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Understand and voluntarily sign an informed consent form

          -  Age ≥65 years or not eligible for high dose therapy and autologous stem cell
             transplant

          -  Able to adhere to study visit schedule and other protocol requirements

          -  Diagnosed with multiple myeloma and considered to have active disease. Patients must
             not have received an active chemotherapy regimen or Dexamethasone. Patients may have
             received palliative radiotherapy at least 2 weeks prior to the study start.

          -  Measurable myeloma paraprotein levels in serum (≥ 0.5 g/dL), urine (≥ 0.2 g excreted
             in a 24-hour urine collection sample) or by serum free light chains (involved free
             light chain greater than 100mg/L)

          -  Eastern Cooperative Group (ECOG) Performance Status of 0 or 1

          -  Serum bilirubin levels ≤1.5 times the upper limit of the normal (ULN) range for the
             laboratory

          -  Serum aspartate transaminase (AST) or serum alanine transaminase (ALT) levels ≤2 x ULN

          -  Adequate bone marrow function: Absolute neutrophil count ≥ 1,000 cells/mm³ (1.0 x
             10^9/L); Platelets ≥ 100,000 /mm³

          -  Hemoglobin > 8 g/dL

          -  Adequate renal function: Calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault
             formula

          -  Low risk myeloma is defined as the absence of the following adverse features[21]:
             t(4;14) by FISH or metaphase cytogenetics; t(14,16) or t(14;20) by FISH or metaphase
             cytogenetics; Deletion 17q13 by FISH; Deletion 13 by metaphase analysis; Aneuploidy by
             metaphase analysis; Β2 microglobulin > 5.5.

          -  Able to tolerate one of the following thromboprophylactic strategies: aspirin, low
             molecular weight heparin or warfarin (coumadin)

          -  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 milli-international units per milliliter
             (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 4 weeks before taking lenalidomide. FCBP must also agree to
             ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact
             with a female of child bearing potential even if they have had a successful vasectomy.

        Exclusion Criteria:

          -  Ongoing severe infection requiring intravenous antibiotic treatment

          -  Life expectancy of less than 3 months

          -  Performance status of 2, 3 or 4

          -  Prior malignancy, except for adequately treated basal cell or squamous cell skin
             cancer, in-situ cervical cancer, or other cancer from which the patient has been
             disease-free for at least 2 years

          -  Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma
             cell dyscrasia

          -  Uncontrolled medical problems such as diabetes mellitus, congestive heart failure,
             coronary artery disease, hypertension, unstable angina, arrhythmias), pulmonary,
             hepatic and renal diseases unless renal insufficiency is felt to be secondary to
             multiple myeloma.

          -  Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the subject from signing the informed consent form

          -  Pregnant or lactating

          -  Any condition, including the presence of laboratory abnormalities, which places the
             patient at unacceptable risk if he/she were to participate in the study or confounds
             the ability to interpret data from the study

          -  Known hypersensitivity to thalidomide

          -  Use of any other experimental drug or therapy within 28 days of baseline.

          -  The development of erythema nodosum if characterized by a desquamating rash while
             taking thalidomide or similar drugs

          -  Any prior use of lenalidomide

          -  Concurrent use of other anti-cancer agents or treatments

          -  Known seropositive for or active viral infection with human immunodeficiency virus
             (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are
             seropositive because of hepatitis B virus vaccine are eligible.