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A Phase II Clinical Trial of Lenalidomide Intensification in Patients With Serologic/Asymptomatic Progression of Multiple Myeloma While on Lenalidomide Maintenance After Autologous Stem Cell Transplantation

Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

A Phase II Clinical Trial of Lenalidomide Intensification in Patients With Serologic/Asymptomatic Progression of Multiple Myeloma While on Lenalidomide Maintenance After Autologous Stem Cell Transplantation

Inclusion Criteria:

- Patients must be 18 years of age or above at the time of enrollment.

- Patients must show evidence of asymptomatic relapse and/or progression of disease
(increasing M spike in serum or urine by consensus criteria) while on lenalidomide
maintenance after HDM/ASCT as part of initial line of therapy.

- Patient must have myeloma that is measurable by either serum or urine evaluation of
the monoclonal component or by assay of serum free light chains. Measurable disease
is defined as one or more of the following: serum M-protein > or = to 1 g/dl, urine
M-protein > or = to 200 mg/24 h, and/or serum FLC assay: involved FLC level > 10
mg/dL with abnormal serum FLC ratio.

- Patients must have adequate organ function including: Hepatic function with Bilirubin
<2x the upper limit of normal and ALT and AST < 3 x the upper limit of normal; renal
function with creatinine clearance > or = to 60 ml/min using the Cockcroft-Gault
formula; hematologic function as defined by an absolute neutrophil count > 1000
neutrophils per microliter, platelet > 50,000 platelets per microliter and hemoglobin
of > or = to 9 gm/dL without transfusion support

- All study participants must be registered into the mandatory RevAssist® program, and
be willing and able to comply with the requirements of RevAssist®.

- Females of childbearing potential (FCBP)1 must have a negative serum or urine
pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again
within 24 hours prior to prescribing lenalidomide for Cycle 1 (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 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. See Appendix: Risks of Fetal Exposure,
Pregnancy Testing Guidelines and Acceptable Birth Control Methods.

Exclusion Criteria:

- Patients with symptomatic relapse and/or progression of multiple myeloma. (Appendix

- Patients with plasma cell leukemia.

- Karnofsky performance score less than 70% or ECOG performance status greater than 2.

- Patients with uncontrolled bacterial, viral or fungal infections (currently taking
medication and progression of clinical symptoms).

- Patients with prior malignancies except resected basal cell carcinoma or treated
cervical carcinoma in situ or other cancer treated with curative intent > 5 years
previously. Cancer treated with curative intent < 5 years previously will not be
allowed unless approved by the Protocol Chairs.

- Female patients who are pregnant (positive HCG) or breastfeeding. (Lactating females
must agree not to breast feed while taking lenalidomide)

- Patients seropositive for the human immunodeficiency virus (HIV).

- Prior organ transplant requiring immunosuppressive therapy.

- Patients who were previously exposed to higher doses of lenalidomide and who
developed severe adverse events at higher doses that preclude incremental dosing.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall response rate (ORR)

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Hani Hassoun, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2011

Completion Date:

October 2013

Related Keywords:

  • Multiple Myeloma
  • 11-107
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Rochester Medical CenterRochester, New York  14642
SUNY Downstate Medical CenterBrooklyn, New York  11203
Montefiore Medical CenterBronx, New York  10467-2490
Weill Cornell Medical CenterNew York, New York  10021
Stamford HospitalStamford, Connecticut  06904
Memorial Sloan-Kettering at Basking RidgeBasking Ridge, New Jersey  07920
Memoral Sloan Kettering Cancer CenterBasking Ridge, New Jersey  
Memoral Sloan Kettering Cancer Center at PhelpsSleepy Hollow, New York  10591
Memorial Sloan-Kettering at Mercy Medical CenterRockville Centre, New York  
North Shore LIJNew Hyde Park, New York  11040