Lenalidomide (Revlimid®) Plus Low-dose Dexamethasone (Ld x 4 Cycles) Then Stem Cell Collection Followed by Randomization to Continued Ld or Stem Cell Transplantation (SCT) Plus Maintenance L

Last updated: March 14, 2019
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Completed

Phase

2

Condition

Bone Diseases

Cancer/tumors

Cancer

Treatment

N/A

Clinical Study ID

NCT00807599
08-121
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to compare the effects, good and bad, of two ways to treat patients with standard-risk symptomatic multiple myeloma. Patients with standard-risk myeloma have myeloma with specific features: levels of 2 blood tests have to be in a specific range and there can be no myeloma tumors found outside of the bones or bone marrow, the areas where myeloma is usually discovered. In past clinical studies, patients with standard-risk myeloma have done well with intensive therapy in the form of stem cell transplant. But multiple myeloma is not curable and, although it may respond to standard treatments including stem cell transplant, myeloma always recurs.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 and ≤ 75

  • Histologic and serologic findings from MSKCC confirming the diagnosis of multiplemyeloma. Standard diagnostic criteria for multiple myeloma will be used, as per therevised International Myeloma Working Group diagnostic criteria.

  • Patients must have symptomatic multiple myeloma without advanced organ damage (such asmultiple fractures or advanced bone disease causing immobilization, renal failure,spinal cord compression, or organ compromise due to soft tissue plasmacytoma). Ifimmediate therapy with radiation and high-dose steroids (eg, for cord compression) orwith bortezomib-based therapy (eg, for renal failure) is required, the patient is noteligible for this trial.

  • Patients may have received 1 cycle of prior therapy with dexamethasone for multiplemyeloma.

  • Adequate organ function is required, defined as follows:

  • ANC ≥ 1,500/μl and platelets ≥ 100,000/μl (unless low ANC and platelets are due tomultiple myeloma)

  • Serum bilirubin ≤ 2.0 mg/dl

  • AST, ALT and alkaline phosphatase < 3 times the upper limit of laboratory normal

  • Adequate renal function as assessed by calculated creatinine using Cockcroft-Gaultestimation of CrCl (see Appendix I): Subjects must have calculated creatinineclearance ≥ 30ml/min by Cockcroft-Gault formula

  • Performance status (ECOG) ≤ 2 (Appendix E).

  • Eligible for SCT with LVEF ≥ 50% by MUGA or ECHO, and diffusing capacity > 50%predicted by pulmonary function testing

  • Ability to understand the investigational nature of this study and to give informedconsent

  • All study participants must be registered into the mandatory Revlimid REMS® program,and be willing and able to comply with the requirements the of Revlimid REMS® program

  • Females of childbearing potential (FCBP)† must have a negative serum or urinepregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior toand again within 24 hours prior to prescribing lenalidomide for cycle 1 (prescriptionsmust be filled within 7 days) and must either commit to continued abstinence fromheterosexual intercourse or begin TWO acceptable methods of birth control, one highlyeffective method and one additional effective method AT THE SAME TIME, at least 28days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancytesting. Men must agree not to father a child and agree to use a latex condom duringsexual contact with females of child bearing potential even if they have had asuccessful vasectomy. See Appendix C: Risks of Fetal Exposure, Pregnancy TestingGuidelines and Acceptable Birth Control Methods.

  • Able to take aspirin 325mg or 81mg daily as prophylactic anticoagulation (patientsintolerant to ASA may use Coumadin or low molecular weight heparin).

Exclusion

Exclusion Criteria:

  • Prior treatment for myeloma except for one cycle of dexamethasone

  • History of thromboembolic disease within the past 6 months regardless ofanticoagulation

  • Myocardial infarction within 6 months prior to enrollment, or New York HospitalAssociation (NYHA) Class III or IV heart failure (see APPENDIX F), uncontrolledangina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence ofacute ischemia or active conduction system abnormalities.

  • Pregnant or breast-feeding women are excluded due to the potential teratogenicity oflenalidomide.

  • Concurrent active malignancy other than non-melanoma skin cancers or carcinoma-insituof the cervix, or presence of myelodysplastic or myeloproliferative disease. Patientswith prior malignancies with a disease-free interval of ≥ 5 years are eligible.

  • Patients who have had prior malignancies within the past 5 years but are considered tobe "cured" with a low likelihood of recurrence may be eligible at the discretion ofthe Principal Investigator.

  • Active hepatitis B or C infection

  • HIV 1 or 2 positivity

  • Any other medical condition or laboratory evaluation that, in the treating physician'sor principal investigator's opinion, makes the patient unsuitable to participate inthis clinical trial

Study Design

Total Participants: 67
Study Start date:
December 10, 2008
Estimated Completion Date:
July 31, 2018

Connect with a study center

  • Memoral Sloan Kettering Cancer Center

    Basking Ridge, New Jersey
    United States

    Site Not Available

  • Memorial Sloan-Kettering Cancer Center @ Suffolk

    Commack, New York 11725
    United States

    Site Not Available

  • Memorial Sloan Kettering West Harrison

    Harrison, New York 10604
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Memorial Sloan Kettering at Mercy Medical Center

    Rockville Centre, New York
    United States

    Site Not Available

  • Memoral Sloan Kettering Cancer Center at Phelps

    Sleepy Hollow, New York 10591
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center

    Sleepy Hollow, New York 10591
    United States

    Site Not Available

  • Memorial Sloan Kettering West Harrison

    West Harrison, New York 10604
    United States

    Site Not Available

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