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Phase II Study of Response Adapted Therapy Using Single Agent Lenalidomide in Older Adults With Newly Diagnosed, Standard Risk Multiple Myeloma

Phase 2
65 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

Phase II Study of Response Adapted Therapy Using Single Agent Lenalidomide in Older Adults With Newly Diagnosed, Standard Risk Multiple Myeloma

Summary: Patients will be started on the study drug, lenalidomide on Day 1, Cycle 1.
Lenalidomide is a capsule that is to be taken orally (by mouth). If the patient's disease
progresses after 2 cycles of therapy, a low dose of dexamethasone will be added. If the
patient's disease is stable after 2 cycles of therapy, the use of an alternate
corticosteroid (prednisone) will be added to the lenalidomide therapy they are receiving.
Dexamethasone and prednisone are in tablet form and will be taken orally (by mouth).
However, if the patient has a minimal response after an additional 2 cycles of lenalidomide
therapy, the therapy will be continued until their disease progresses. See the intervention
descriptions for further details.

Inclusion Criteria:

- Understand and voluntarily sign an informed consent form

- Age ≥65 years or not eligible for high dose therapy and autologous stem cell

- Able to adhere to study visit schedule and other protocol requirements

- Diagnosed with multiple myeloma and considered to have active disease. Patients must
not have received an active chemotherapy regimen or Dexamethasone. Patients may have
received palliative radiotherapy at least 2 weeks prior to the study start.

- Measurable myeloma paraprotein levels in serum (≥ 0.5 g/dL), urine (≥ 0.2 g excreted
in a 24-hour urine collection sample) or by serum free light chains (involved free
light chain greater than 100mg/L)

- Eastern Cooperative Group (ECOG) Performance Status of 0 or 1

- Serum bilirubin levels ≤1.5 times the upper limit of the normal (ULN) range for the

- Serum aspartate transaminase (AST) or serum alanine transaminase (ALT) levels ≤2 x

- Adequate bone marrow function: Absolute neutrophil count ≥ 1,000 cells/mm³ (1.0 x
10^9/L); Platelets ≥ 100,000 /mm³

- Hemoglobin > 8 g/dL

- Adequate renal function: Calculated creatinine clearance ≥ 30ml/min by
Cockcroft-Gault formula

- Low risk myeloma is defined as the absence of the following adverse features[21]:
t(4;14) by FISH or metaphase cytogenetics; t(14,16) or t(14;20) by FISH or metaphase
cytogenetics; Deletion 17q13 by FISH; Deletion 13 by metaphase analysis; Aneuploidy
by metaphase analysis; Β2 microglobulin > 5.5.

- Able to tolerate one of the following thromboprophylactic strategies: aspirin, low
molecular weight heparin or warfarin (coumadin)

- 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) must have a negative serum or urine
pregnancy test with a sensitivity of at least 50 milli-international units per
milliliter (mIU/mL) within 10 14 days prior to and again within 24 hours of
prescribing 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 4 weeks before taking lenalidomide. FCBP must also
agree to ongoing pregnancy testing. Men must agree to use a latex condom during
sexual contact with a female of child bearing potential even if they have had a
successful vasectomy.

Exclusion Criteria:

- Ongoing severe infection requiring intravenous antibiotic treatment

- Life expectancy of less than 3 months

- Performance status of 2, 3 or 4

- Prior malignancy, except for adequately treated basal cell or squamous cell skin
cancer, in-situ cervical cancer, or other cancer from which the patient has been
disease-free for at least 2 years

- Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma
cell dyscrasia

- Uncontrolled medical problems such as diabetes mellitus, congestive heart failure,
coronary artery disease, hypertension, unstable angina, arrhythmias), pulmonary,
hepatic and renal diseases unless renal insufficiency is felt to be secondary to
multiple myeloma.

- Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form

- Pregnant or lactating

- Any condition, including the presence of laboratory abnormalities, which places the
patient at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study

- Known hypersensitivity to thalidomide

- Use of any other experimental drug or therapy within 28 days of baseline.

- The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs

- Any prior use of lenalidomide

- Concurrent use of other anti-cancer agents or treatments

- Known seropositive for or active viral infection with human immunodeficiency virus
(HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are
seropositive because of hepatitis B virus vaccine are eligible.

Type of Study:


Study Design:

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

Outcome Measure:

Combined Therapy - Number of Participants With Progression Free Survival (PFS)

Outcome Description:

The 12-month progression free survival (PFS) of older adults with mildly symptomatic multiple myeloma treated on this response adapted approach (i.e. time from start of lenalidomide to failure of lenalidomide and low dose dexamethasone)

Outcome Time Frame:

12 Months

Safety Issue:


Principal Investigator

Rachid Baz, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

January 2010

Completion Date:

June 2014

Related Keywords:

  • Multiple Myeloma
  • Newly Diagnosed Standard Risk Multiple Myeloma
  • Senior Adults
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612