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Trial record 19 of 2511 for:    "Plasma Cell Neoplasm"

Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00478218
Recruitment Status : Completed
First Posted : May 24, 2007
Results First Posted : July 27, 2011
Last Update Posted : August 31, 2011
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Brief Summary:
RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with cyclophosphamide and dexamethasone may kill more cancer cells.> PURPOSE: This phase II trial is studying how well giving lenalidomide together with cyclophosphamide and dexamethasone works in treating patients with newly diagnosed multiple myeloma.

Condition or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Drug: cyclophosphamide Drug: dexamethasone Drug: lenalidomide Phase 2

Detailed Description:



* 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Revlimid, Cyclophosphamide, and Dexamethasone in Patients With > Newly Diagnosed Active Multiple Myeloma
Study Start Date : July 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : April 2011

Arm Intervention/treatment
Experimental: Lenalidomide/Cyclophosphamide/Dexamethasone Drug: cyclophosphamide
300 mg/m2 administrated by PO (with food)on Days 1, 8, 15 (up to 12 cycles) OR 300 mg administrated by PO (with food)on Days 1, 8, 15 (up to 12 cycles)
Other Name: Cytoxan, CTX, Neosar®

Drug: dexamethasone
40 mg administrated by PO (with food)on Days 1, 8, 15 & 22
Other Name: Decadron

Drug: lenalidomide
25 mg administrated by PO (with food)on Days 1-21
Other Name: Revlimid®

Primary Outcome Measures :
  1. Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment [ Time Frame: Duration of Treatment (up to 5 years) ]

    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

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: up to 5 years ]
    OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.

  2. Progression-free Survival (PFS) [ Time Frame: up to 5 years ]

    PFS was defined as the time from registration to progression or death due to any cause. The median PFS with 95%CI was estimated using the Kaplan Meier method.


    Progression was defined as any one or more of the following:


    An increase of 25% from lowest confirmed response in:

    • Serum M-component (absolute increase >= 0.5g/dl)
    • Urine M-component (absolute increase >= 200mg/24hour
    • Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl
    • Bone marrow plasma cell percentage (absolute increase of >=10%)

  3. Duration of Response (DOR) [ Time Frame: up to 5 years ]
    Duration of response was calculated from the documentation (date) of first response (CR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded. The median DOR with 95%CI was estimated using the Kaplan Meier method.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00478218

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United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
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Study Chair: Shaji K. Kumar, MD Mayo Clinic
Principal Investigator: Craig B. Reeder, MD Mayo Clinic

Publications of Results:
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Responsible Party: Mayo Clinic Identifier: NCT00478218     History of Changes
Other Study ID Numbers: CDR0000546657
P30CA015083 ( U.S. NIH Grant/Contract )
MC058E ( Other Identifier: Mayo Clinic Cancer Center )
06-002786 ( Other Identifier: Mayo Clinic IRB )
RV-MM-PI-0116 ( Other Identifier: Celgene Protocol )
First Posted: May 24, 2007    Key Record Dates
Results First Posted: July 27, 2011
Last Update Posted: August 31, 2011
Last Verified: August 2011

Keywords provided by Mayo Clinic:
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal