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Phase 2 Trial of Retreatment With Lenalidomide and Dexamethasone for Patients With Relapsed Myeloma

Phase 2
18 Years
Not Enrolling
Refractory Multiple Myeloma

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Trial Information

Phase 2 Trial of Retreatment With Lenalidomide and Dexamethasone for Patients With Relapsed Myeloma


I. To assess the confirmed response rate of the combination of lenalidomide (Revlimid®), and
dexamethasone in patients with relapsed myeloma who have previously become refractory to
lenalidomide or pomalidomide.


I. To assess the toxicity of the combination in patients with relapsed myeloma who have
previously received lenalidomide or pomalidomide.

II. To assess time to progression and overall survival.


Patients receive lenalidomide orally (PO) on days 1-21 and dexamethasone PO on days 1, 8,
15, and 22. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months.

Inclusion Criteria:

- Calculated creatinine clearance >= 30 ml/min by Cockcroft-Gault formula

- Absolute neutrophil count >= 1000μL

- (Untransfused) platelet count >= 50000/μL

- Hemoglobin >= 8.0 g/dL

- Relapsed myeloma that previously became refractory to lenalidomide or pomalidomide,
after initial response of partial response or better to the drug; refractory is
defined as progression on treatment with a dose of at least 10 mg daily for
lenalidomide and 1 mg daily for pomalidomide; at least six months should have elapsed
since previous lenalidomide or pomalidomide therapy was stopped

- Measurable disease of multiple myeloma as defined by at least ONE of the following:

- Serum monoclonal protein >= 1.0 g/dL

- >= 200 mg of monoclonal protein in the urine 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)

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

- Previously treated; NOTE: No limit to prior therapy provided there is adequate
residual organ function

- Provide informed written consent

- Females of childbearing potential (FCBP) must have a negative serum pregnancy test
with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again
within 24 hours prior to prescribing lenalidomide for cycle 1 (prescriptions must be
filled within 7 days as required by RevAssist), 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 lenalidomide; FCBP must also agree to
ongoing pregnancy testing; men must agree to use a latex condom during sexual contact
with a FCBP even if they have had a successful vasectomy; all study participants must
be registered into the RevAssist® program, and be willing and able to comply with the
requirements of RevAssist® mandatory Rev; a female of childbearing potential is a
sexually mature woman who: 1) has not undergone a hysterectomy or bilateral
oophorectomy; or 2) 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)

- Willing to return to Mayo Clinic enrolling institution for follow-up

Exclusion Criteria:

- Residual toxicity of > grade 1 from prior therapy

- Other active malignancy < 1 year prior to registration; EXCEPTIONS: Non-melanotic
skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history of prior
malignancy, they must not be receiving other specific treatment for their cancer

- Any of the following:

- Pregnant women

- Nursing women (lactating females must agree not to breast feed while taking

- This study involves an agent that may have genotoxic, mutagenic and teratogenic
effects; men or women of childbearing potential who are unwilling to employ
adequate contraception (condoms, diaphragm, birth control pills, injections,
intrauterine device [IUD], or abstinence, etc.)

- Other co-morbidity which would interfere with patient's ability to participate in
trial, e.g. uncontrolled infection, uncompensated heart or lung disease

- Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered
investigational; NOTE: Bisphosphonates are considered to be supportive care rather
than therapy, and are thus allowed while on protocol treatment

- New York Heart Association classification III or IV

- Diagnosed active deep vein thrombosis (DVT) that has not been therapeutically

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of confirmed tumor responses defined to be a partial response or better noted as the objective status on two consecutive evaluations

Outcome Description:

Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

Outcome Time Frame:

Up to 1 year

Safety Issue:


Principal Investigator

Shaji Kumar

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Institutional Review Board

Study ID:




Start Date:

April 2013

Completion Date:

Related Keywords:

  • Refractory Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Mayo Clinic Rochester, Minnesota  55905