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A Phase II Trial of Revlimid, Cyclophosphamide, and Dexamethasone in Patients With > Newly Diagnosed Active Multiple Myeloma

Phase 2
18 Years
Not Enrolling
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

A Phase II Trial of Revlimid, Cyclophosphamide, and Dexamethasone in Patients With > Newly Diagnosed Active Multiple Myeloma



* Assess the response rate in patients with newly diagnosed active multiple myeloma treated
with lenalidomide, cyclophosphamide, and dexamethasone.


- Assess the toxicity of this regimen in these patients.

- Determine the time to progression in patients treated with this regimen. OUTLINE:
Patients receive oral lenalidomide on days 1-21, oral cyclophosphamide on days 1, 8,
and 15, and oral dexamethasone on days 1, 8, 15, and 22. Treatment repeats every 28
days for 4-12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months for up to 5 years.

Inclusion Criteria


- Diagnosis of multiple myeloma

- Newly diagnosed disease

- Symptomatic disease

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

- Serum monoclonal protein ≥ 1.0 g by protein electrophoresis

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

- Measurable soft tissue plasmacytoma not previously irradiated

- No monoclonal gammopathy of undetermined significance or smoldering myeloma


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

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 75,000/mm^3

- Hemoglobin ≥ 8.0 g/dL

- Creatinine ≤ 2.5 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective double-method contraception (1 highly effective
and 1 additional method) for 1 month before, during, and for 4 weeks after completion
of study therapy

- No uncontrolled infection

- No other active malignancy

- No other malignancies within the past 5 years except for currently treated basal cell
or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast

- No NYHA class III-IV congestive heart failure

- No untreated active deep vein thrombosis


- At least 3 weeks since prior radiotherapy for solitary plasmacytoma

- Prior clarithromycin, therapeutic dehydroepiandrosterone (DHEA), anakinra,
pamidronate disodium, or zoledronic acid allowed

- No prior cytotoxic chemotherapy

- No prior corticosteroids (except for treatment of a nonmalignant disorder)

- Concurrent corticosteroids (prednisone ≤ 20 mg/per day) allowed

- No concurrent radiotherapy except palliative radiotherapy for a single painful bone
lesion or fracture

Type of Study:


Study Design:

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

Outcome Measure:

Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment

Outcome Description:

Response that was confirmed on 2 consecutive evaluations during treatment Complete Response(CR): Complete disappearance of M-protein from serum & urine on immunofixation, normalization of Free Light Chain (FLC) ratio & <5% plasma cells in bone marrow (BM) Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM Partial Response PR): >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels

Outcome Time Frame:

Duration of Treatment (up to 5 years)

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:

July 2006

Completion Date:

April 2011

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 Scottsdale Scottsdale, Arizona  85259
Mayo Clinic Cancer Center Rochester, Minnesota  55905