UARK 2009-09 Myeloma Cure Project: Prospective Trial of Indefinite Revlimid Maintenance Versus Observation for Currently Event-Free Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Revlimid
Intervention description: 10 mg/day in the morning same time each day
Intervention MeSH terms: Lenalidomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Revlimid; progression free; Lenalidomide

Summary:

      The purpose of this study is to determine in a phase II trial, whether further maintenance
      therapy with Revlimid can extend the duration of progression-free survival and the duration
      of complete or near complete response compared to no further therapy beyond the TT3
      protocol-prescribed 3 years of maintenance with 1 year of VTD plus 2 years with TD, 3 years
      with VTD (2003-33) or VRD (2006-66).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants of all races/ethnicities with multiple myeloma previously
             enrolled on UARK 2003-33 or 2006-66.

          -  Participant has completed 3 years of maintenance therapy with one of the three study
             drugs of VTD or VRD and disease status has remained event free (includes patients who
             prematurely discontinued maintenance therapy as long as 3 years have elapsed since
             beginning of maintenance).

          -  All patients must be ages 18 years of age or greater at the time of signing the
             informed consent form.

          -  Participant has adequate hematopoietic reserve, defined as platelets > 50,000/μL (in
             participants with bone marrow hypoplasia, remaining peripheral blood progenitor cells
             can be infused to boost hematopoietic reserve prior to enrollment).

          -  Participant has adequate renal function defined as serum creatinine < 3 mg/dL prior to
             enrolling on study

          -  Total bilirubin ≤ 1.5 mg/dL prior to enrolling on study

          -  AST (SGOT) and ALT (SGPT) ≤ 2 x ULN prior to enrolling on study

          -  Patient must have signed an IRB-approved informed consent and understand the
             investigational nature of the study.

          -  All study participants must be registered into the mandatory RevAssist® program, and
             be willing and able to comply with the requirements of RevAssist®

          -  Pregnant or nursing women may not participate. 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 Revlimid® (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 Revlimid® (lenalidomide).

          -  FCBP must also agree to ongoing pregnancy testing.

          -  Lactating females must agree that they will not breastfeed.

          -  Men must agree to use a latex condom during sexual contact with a FCBP even if they
             have had a successful vasectomy. See Appendix: Risks of Fetal Exposure,

          -  Pregnancy Testing Guidelines and Acceptable Birth Control Methods † A female of
             childbearing potential is a sexually mature woman who:

               -  has not undergone a hysterectomy or bilateral oophorectomy

               -  has not been naturally postmenopausal for at least 24 consecutive months (i.e.,
                  has had menses at any time in the preceding 24 consecutive months).

        Exclusion Criteria:

          -  Any condition that the PI believes, laboratory abnormality, or psychiatric illness
             that would prevent the subject from being enrolled in the research study.

          -  Pregnant or breast feeding females. (Lactating females must agree not to breast feed
             while taking Revlimid®)

          -  Any condition, including the presence of laboratory abnormalities, which places the
             subject at unacceptable risk if he/she were to participate in the study or confounds
             the ability to interpret data from the study.

          -  Use of any other experimental drug or therapy within 28 days of baseline.

          -  Known hypersensitivity to thalidomide.

          -  The development of erythema nodosum if characterized by a desquamating rash while
             taking thalidomide or similar drugs.

          -  Concurrent use of other anti-cancer agents or treatments.

          -  Known positive for HIV or infectious hepatitis, type B or C.