Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma

Not Recruiting

Trial ID: NCT00689936


The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose dexamethasone to that of the combination of melphalan, prednisone and thalidomide.

Official Title

A Phase III, Randomized, Open-label, 3-arm Study to Determine the Efficacy and Safety of Lenalidomide(REVLIMID) Plus Low-dose Dexamethasone When Given Until Progressive Disease or for 18 Four-week Cycles Versus the Combination of Melphalan, Prednisone, and Thalidomide Given for 12 Six-week Cycles in Patients With Previously Untreated Multiple Myeloma Who Are Either 65 Years of Age or Older or Not Candidates for Stem Cell Transplantation.

Stanford Investigator(s)

Caroline Berube
Caroline Berube

Clinical Associate Professor, Medicine - Hematology

Jason Gotlib

Professor of Medicine (Hematology)


Inclusion Criteria:

   1. Must understand and voluntarily sign informed consent form

   2. Age ≥ 18 years at the time of signing consent

   3. Previously untreated, symptomatic multiple myeloma as defined by the 3 criteria below:

      - MM diagnostic criteria (all 3 required):

      - Monoclonal plasma cells in the bone marrow ≥10% and/or presence of a
      biopsy-proven plasmacytoma

      - Monoclonal protein present in the serum and/or urine

      - Myeloma-related organ dysfunction (at least one of the following) [C] Calcium
      elevation in the blood (serum calcium >10.5 mg/dl or upper limit of normal) [R]
      Renal insufficiency (serum creatinine >2 mg/dl) [A] Anemia (hemoglobin <10 g/dl
      or 2 g < laboratory normal) [B] Lytic bone lesions or osteoporosis

   AND have measurable disease by protein electrophoresis analyses as defined by the

      - IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dl
      or urine M-protein level ≥ 200 mg/24 hours

      - IgA multiple myeloma: Serum M-protein level ≥ 0.5 g/dl or urine M-protein level ≥
      200 mg/24 hours

      - IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by
      skeletal survey plain films): Serum M-protein level ≥ 1.0 g/dl or urine M-protein
      level ≥ 200mg/24hours

      - IgD multiple myeloma: Serum M-protein level ≥ 0.05 g/dl or urine M-protein level
      ≥ 200 mg/24 hours

      - Light chain multiple myeloma: Serum M-protein level ≥ 1.0 g/dl or urine M-protein
      level ≥ 200 mg/24 hours

   AND are at least 65 years of age or older or, if younger than 65 years of age, are not
   candidates for stem cell transplantation because:

      - The patient declines to undergo stem cell transplantation or

      - Stem cell transplantation is not available to the patient due to cost or other

   4. ECOG performance status of 0, 1, or 2

   5. Able to adhere to the study visit schedule and other protocol requirements

   6. Females of child-bearing potential (FCBP)^2:

      1. Must agree to undergo two medically supervised pregnancy tests prior to starting
      study therapy with either Rd or MPT. The first pregnancy test will be performed
      within 10-14 days prior to the start of Rd or MPT and the second pregnancy test
      will be performed within 24 hours prior to the start of Rd or MPT. She must also
      agree to ongoing pregnancy testing during the course of the study and after the
      end of study therapy. This applies even if the patient practices complete and
      continued sexual abstinence.

      2. Must commit to either continued abstinence from heterosexual intercourse (which
      must be reviewed on a monthly basis) or agree to use and be able to comply with
      effective contraception without interruption, 28 days prior to starting study
      drug, during the study therapy (including during periods of dose interruptions),
      and for 28 days after discontinuation of study therapy.

   7. Male Patients:

      1. Must agree to use a condom during sexual contact with a FCBP, even if they have
      had a vasectomy, throughout study drug therapy, during any dose interruption and
      after cessation of study therapy.

      2. Must agree to not donate semen during study drug therapy and for a period after
      end of study drug therapy.

      3. Must practice complete abstinence or agree to use a condom during sexual contact
      with a pregnant female or a female of childbearing potential while participating
      in the study, during dose interruptions and for at least 28 days following study
      drug discontinuation, even if he has undergone a successful vasectomy.

   8. All patients must:

      1. Have an understanding that the study drug could have a potential teratogenic

      2. Agree to abstain from donating blood while taking study drug therapy and
      following discontinuation of study drug therapy.

      3. Agree not to share study medication with another person. All FCBP and male
      patients must be counseled about pregnancy precautions and risks of fetal

Exclusion Criteria:

   1. Previous treatment with anti-myeloma therapy (does not include radiotherapy,
   bisphosphonates, or a single short course of steroid [i.e., less than or equal to the
   equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid
   treatment must not have been given within 14 days of randomization]).

   2. Any serious medical condition that places the patient at an unacceptable risk if he or
   she participates in this study. Examples of such a medical condition are, but are not
   limited to, patient with unstable cardiac disease as defined by: Cardiac events such
   as MI within the past 6 months, NYHA heart failure class III-IV, uncontrolled atrial
   fibrillation or hypertension; patients with conditions requiring chronic steroid or
   immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and
   lupus, that likely need additional steroid or immunosuppressive treatments in addition
   to the study treatment.

   3. Pregnant or lactating females.

   4. Any of the following laboratory abnormalities:

      - Absolute neutrophil count (ANC) < 1,000/µL (1.0 x 109/L)

      - Untransfused platelet count < 50,000 cells/µL (50 x 10^9/L)

      - Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)

   5. Renal failure requiring hemodialysis or peritoneal dialysis.

   6. Prior history of malignancies, other than multiple myeloma, unless the patient has
   been free of the disease for ≥ 3 years. Exceptions include the following:

      - Basal cell carcinoma of the skin

      - Squamous cell carcinoma of the skin

      - Carcinoma in situ of the cervix

      - Carcinoma in situ of the breast

      - Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)

   7. Patients who are unable or unwilling to undergo antithrombotic therapy.

   8. Peripheral neuropathy of > grade 2 severity.

   9. Known HIV positivity or active infectious hepatitis, type A, B, or C. Primary AL
   (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.

      - 1 A variety of other types of end organ dysfunctions can occasionally occur and
      lead to a need for therapy. Such dysfunction is sufficient to support
      classification as myeloma if proven to be myeloma-related.

      - 2 A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or
      bilateral oophorectomy or 2) has not been naturally postmenopausal (i.e.,
      amenorrhea following cancer therapy does not rule out childbearing potential) for
      at least 24 consecutive months (i.e., has had menses at any time in the preceding
      24 consecutive months).


drug: Lenalidomide and low-dose dexamethasone

drug: Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles

drug: Melphalan, Prednisone and Thalidomide

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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