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A Phase II Trial of Revlimid® and "On Demand" Dexamethasone Dosing in Patients With Newly Diagnosed Symptomatic Multiple Myeloma

Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

A Phase II Trial of Revlimid® and "On Demand" Dexamethasone Dosing in Patients With Newly Diagnosed Symptomatic Multiple Myeloma



- To assess the progression-free survival at 1 year in patients with newly diagnosed
symptomatic multiple myeloma treated with lenalidomide alone or in combination with
dexamethasone added for disease progression or lack or partial response.


- To assess the response rate of this regimen in these patients.

- To assess the toxicity of this regimen in these patients.


- To examine the effect of lenalidomide alone on tumor specific immunity and global
parameters of immune function.

- To examine the effect of dexamethasone addition in patients requiring steroids.

- To correlate changes in parameters of immune response and measures of disease response.

- To examine the antiangiogenic activity of lenalidomide alone and in combination with

- To examine the effect of lenalidomide alone on tumor cell survival and proliferation.

OUTLINE: Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every
28 days for up to 18 courses in the absence of second disease progression or unacceptable
toxicity. Beginning in course 4, patients experiencing stable or progressive disease also
receive concurrent oral dexamethasone once daily on days 1, 8, 15, and 22 and for all
subsequent courses.

Blood and bone marrow samples are collected periodically for pharmacological and correlative
studies. Samples are analyzed for parameters of immune activation, cell proliferation and
apoptosis, and circulating tumor cells and endothelial cells via flow cytometry; global
impact of therapy on immune cell subsets via immunophenotype analysis; and angiogenesis via
CD34 staining.

After completion of study therapy, patients are followed periodically for up to 2 years.

Inclusion Criteria


- Newly diagnosed multiple myeloma, meeting the following criteria:

- Symptomatic disease

- Previously untreated disease

- Measurable or evaluable disease, defined by ≥ 1 of the following:

- Serum monoclonal protein ≥ 1.0 g/dL

- Monoclonal protein > 200 mg by 24-hour urine electrophoresis

- Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum
immunoglobulin kappa:lambda free light chain ratio

- Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)

- Measurable soft tissue plasmacytoma, not previously radiated

- No monoclonal gammopathy of unknown significance or asymptomatic myeloma


- ECOG performance status (PS) 0-2 (PS 3 allowed if secondary to pain)

- ANC ≥ 1,500/μL

- Platelet count ≥ 75,000/μL

- Creatinine ≤ 2.0 mg/dL

- Total bilirubin ≤ 1.5 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 2 effective forms of contraception 28 days prior to, during
and 28 days after study treatment

- Registered into the RevAssist® program and willing to comply with program

- Able to take prophylactic aspirin (325 mg/day) or warfarin or low molecular weight

- Willing to provide mandatory blood and bone marrow samples

- Willing to return for follow up

- No uncontrolled infection

- No NYHA class III or IV heart failure

- No active deep vein thrombosis that has not been therapeutically anticoagulated

- No known hypersensitivity to thalidomide

- No known HIV positivity

- No known hepatitis type A, B, or C infection

- No other prior active malignancy within the past 2 years, except currently treated
basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
or breast

- No development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs


- At least 3 weeks since prior radiotherapy for solitary plasmacytoma

- More than 28 days since other prior experimental drug or therapy

- Prior clarithromycin, DHEA, anakinra, pamidronate, or zoledronic acid allowed

- No prior lenalidomide

- No prior cytotoxic chemotherapy

- No prior corticosteroids (≥ 160 mg of dexamethasone or equivalent) for this disease

- Prior corticosteroid for nonmalignant disease allowed

- Concurrent corticosteroids allowed (≤ 20 mg/day of prednisone or equivalent)

- Concurrent palliative radiotherapy for bone pain or fracture allowed

- No other concurrent anticancer agents or treatments

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival Rate at 12 Months

Outcome Description:

PFS at 12 months is a dichotomized outcome indicating whether or not a participant was progression free (and alive) at 12 months from the date of randomization.

Outcome Time Frame:

12 months from registration

Safety Issue:


Principal Investigator

Shaji K. Kumar, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

December 2008

Completion Date:

October 2013

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma



Mayo Clinic Rochester, Minnesota  55905