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Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma

Phase 3
18 Years
Open (Enrolling)
Light Chain Deposition Disease, Smoldering Multiple Myeloma

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Trial Information

Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma


I. Study the risk of grade 3-4 non-hematologic adverse events in patients with asymptomatic
high-risk smoldering multiple myeloma treated with lenalidomide. (Phase II) II. Compare the
progression-free survival (PFS) of patients with asymptomatic high-risk smoldering multiple
myeloma treated with lenalidomide versus observation alone. (Phase III)


I. Assess the response of patients treated with lenalidomide. (Phase II) II. Determine and
compare the response rate, time to progression, 1-year PFS probability, and the overall
survival of patients treated with lenalidomide versus observation alone. (Phase III) III.
Estimate the incidence of adverse events of these regimens in these patients. (Phase III)


I. Describe the cohort in terms of GEP and cytogenetic risk classification and evaluate
baseline immune and MRI parameters. (Phase II) II. Evaluate the impact of therapy within
GEP-defined risk groups and GEP as a prognostic marker. (Phase III) III. Study the effects
of lenalidomide on laboratory markers of immune function. (Phase III) IV. Study the
prognostic value of MRI-detected asymptomatic bone disease on clinical outcome. (Phase III
V. Evaluate the prognostic effect of baseline high-risk cytogenetic abnormalities on
clinical outcome. (Phase III)


I. To compare QOL change between treatment and observation arms based on the functional
(FWB) and physical (PWB) well-being components of the FACT-General (G) patient-reported
outcome (PRO) measure from registration (prior to initiation of treatment) up to cycle 24.

II. To examine the impact of differential treatment response (PFS), if observed, on QOL
based on the FACT FWB+PWB up to cycle 48.

III. To obtain prospective data on Myeloma specific QOL attributes, utilizing and evaluating
the Multiple Myeloma Subscale (MMS).

OUTLINE: This is a multicenter study.

PHASE II: Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21. Treatment
repeats every 28 days for 6 courses in the absence of disease progression or unacceptable

PHASE III: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive lenalidomide PO QD on days 1-21. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.

ARM II: Patients receive standard of care and undergo observation in the absence of disease

Peripheral blood, bone marrow aspirate, and bone marrow core biopsy samples are collected
for gene expression profiling, immune function, and cytogenetic abnormalities. Patients
complete the Functional Assessment of Cancer Therapy (FACT) Physical Well-Being (PWB), and
FACT Functional Well-Being (FWB) questionnaires at baseline and periodically during study.

After completion of study therapy, patients are followed up periodically for 10 years.

Inclusion Criteria:

- Patients must be diagnosed with asymptomatic high-risk smoldering multiple myeloma
(SMM) within the past 12 months, as confirmed by both of the following:

- Bone marrow plasmacytosis with >= 10% plasma cells or sheet of plasma cells
which must be obtained by bone marrow aspiration and/or biopsy within 4 weeks
prior to randomization

- Abnormal serum free-light chain (FLC) ratio (< 0.125 or > 8.0) by serum FLC
assay; FLC assay must be performed within 28 days of randomization

- Measurable monoclonal protein in the serum >= 1.0 g/dL or urine >= 200 mg/24 hrs

- No lytic lesions on skeletal surveys and no hypercalcemia (i.e., >= 11 mg/dL)

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Absolute neutrophil count (ANC) > 1,500/mm³

- Platelet count > 100,000/mm³

- Hemoglobin > 11 g/dL

- Creatinine clearance > 30 mL/min

- Bilirubin < 1.5 mg/dL

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 times upper
limit of normal

- More than 6 months since active, uncontrolled seizure disorder

- Willing to take some form of anti-coagulation as prophylaxis if there is a history of
or concurrent deep vein thrombosis or pulmonary embolism

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 2 effective methods of contraception for ≥ 28 days before,
during, and ≥ 28 days after completion of study therapy

- Prior malignancy allowed provided treatment of curative intent was delivered and
disease-free for time period considered appropriate for the specific cancer

- Human immunodeficiency virus (HIV)-positive patients allowed provided the following
criteria are met:

- CD4 cell count >= 350/mm³

- No history of acquired immunodeficiency syndrome (AIDS)-related illness

- No uncontrolled intercurrent illness including any of the following:

- Uncontrolled hypertension

- Symptomatic congestive heart failure

- Unstable angina

- Uncontrolled cardiac arrhythmia

- Uncontrolled psychiatric illness or social situation that would limit compliance
with the study

- Prior Stevens Johnson Syndrome

- No peripheral neuropathy >= grade 2

- No active uncontrolled infection

- No New York Heart Association (NYHA) class III or IV heart failure

- No prior or concurrent systemic therapy or radiotherapy for MM

- No prior or concurrent erythropoietin

- No prior glucocorticosteroid for MM

- Prior systemic glucocorticosteroid for non-malignant disorders allowed
(prednisone equivalent ≤ 10 mg/day)

- Prior or concurrent topical or localized glucocorticosteroid to treat
non-malignant comorbid disorders allowed

- No concurrent bisphosphonates

- Prior bisphosphonates or once-a-year intravenous bisphosphonate for osteoporosis

- No concurrent zidovudine or stavudine for HIV-positive patients

- No concurrent chemotherapy including cyclophosphamide and stem cell mobilization

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Grade 3 or higher non-hematologic toxicity based on AdEERS expedited reporting (Phase II)

Outcome Description:

The difference in rates of all Grade 3 or higher toxicities will be evaluated for all randomized patients using the Fisher's Exact Test.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Sagar Lonial

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

October 2010

Completion Date:

Related Keywords:

  • Light Chain Deposition Disease
  • Smoldering Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



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