Lenalidomide and Low-Dose Dexamethasone in Patients with Previously Treated Multiple Myeloma and Kidney Dysfunction

  • Study type:

    Interventional What is this?

    Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Study phase:

    I/II What is this?

    During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

Study IDs

  • Site IRB:

    • Scottsdale/Phoenix, Arizona: 11-002048
    • Rochester, Minnesota: 11-002048
  • NCT ID:

    NCT00790842
  • Sponsor Protocol Number:

    PrE1003

About this study

Patients with previously treated multiple myeloma and kidney dysfunction will be treated with lenalidomide and low-dose dexamethasone. Phase I will study the side effects and best dose of lenalidomide when given together with low-dose dexamethasone therapy. After the maximum safe and tolerated dose is found in Phase I, the study will proceed to Phase II. Phase II will study how well the the treatment works in patients with previously treated (relapsed or refractory) multiple myeloma and kidney dysfunction.

Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with dexamethasone may kill more cancer cells. Lenalidomide and dexamethasone may have different effects in patients who have changes in their kidney function.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Diagnosed with previously treated multiple myeloma.
  • Measurable disease assessed by one of the following ≤21 days prior to registration:
    • Serum monoclonal protein ≥1 g by protein electrophoresis
    • Urine monoclonal protein >200 mg on 24 hour electrophoresis
    • Serum immunoglobulin free light chain ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
    • Monoclonal bone marrow plasmacytosis ≥30% (evaluable disease)
    • NOTE: If both serum and urine m-components are present, both must be followed in order to evaluate response.
  • All previous cancer therapy including chemotherapy, radiation, hormonal therapy and surgery, must be discontinued ≥2 weeks prior to registration.
  • Age ≥18 years.
  • ECOG performance status 0-2.
  • Acceptable organ and marrow function ≤21 days prior to registration:
    • ANC ≥1000/mm³
    • Platelet count ≥75,000/mm³
    • Total bilirubin ≤2 mg/dL
    • AST and ALT ≤3 x upper limit of normal
  • Renal impairment at baseline as measured by serum creatinine clearance (CrCl) ≤60 mL/min ≤21 days prior to registration.
  • Females of Childbearing Potential (FCBP) must have a negative pregnancy test within 10-14 days and again within 24 hours of starting Cycle 1 and must use an effective double-method contraception for ≥28 days prior to, during, and for ≥28 days after completion of study therapy.
  • Able to take required prophylactic anticoagulation.
  • Able to understand and willingness to sign a written informed consent.
  • Willing to provide blood samples for research purposes (Mayo Clinic sites only).
  • If previously received lenalidomide, demonstration of clinical response of any duration or stable disease with progression-free interval of ≥6 months from start of that therapy.

Exclusion Criteria:

  • Concurrent use of other anti-cancer agents or treatments. NOTE: Growth factors and bisphosphonates are allowed as medically indicated. Steroids may be used with an equivalency of up to 20 mg of Prednisone per day as long as the dose has not been adjusted upwards in past 2 weeks prior to study registration.
  • Uncontrolled intercurrent illness including, but not limited to, any of the following:
    • Ongoing or active infection requiring IV antibiotics
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Uncontrolled cardiac arrhythmia
    • Psychiatric illness/social situation that would limit compliance with study requirements.
  • Any of the following as this regimen may be harmful to a developing fetus or nursing child:
    • Pregnant women
    • Breast-feeding women
    • Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception.
  • HIV-positive patients on combination antiretroviral therapy.
  • Known hypersensitivity to thalidomide or other immunomodulatory drugs.
  • History of Stevens-Johnson syndrome characterized by a desquamating rash while taking thalidomide or similar drugs.
  • Other active malignancy except for non melanoma skin cancer or in situ cervical or breast cancer.
  • Concurrent radiation therapy, except for palliation of a single painful bone lesion or fracture.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Joseph Mikhael, M.D.

Open for enrollment

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Joseph Mikhael, M.D.

Open for enrollment

Cancer Center Clinical Trials Referral Office

855-776-0015