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Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
This study is ongoing, but not recruiting participants.
First Received: May 23, 2007   Last Updated: January 7, 2009   History of Changes
Sponsors and Collaborators: Mayo Clinic
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00478218
  Purpose

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 Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: cyclophosphamide
Drug: dexamethasone
Drug: lenalidomide
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Multiple Myeloma
Drug Information available for: Dexamethasone Cyclophosphamide Dexamethasone acetate Doxiproct plus Lenalidomide CC 5013 Dexamethasone Sodium Phosphate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial of Revlimid, Cyclophosphamide, and Dexamethasone in Patients With Newly Diagnosed Active Multiple Myeloma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Confirmed response (complete, partial, or very good partial response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]

Estimated Enrollment: 53
Study Start Date: July 2006
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00478218

Locations
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
Investigators
Study Chair: Shaji K. Kumar, MD Mayo Clinic
Investigator: Craig B. Reeder, MD Mayo Clinic Scottsdale
Investigator: Morie A. Gertz, MD Mayo Clinic
Investigator: Philip R. Greipp, MD Mayo Clinic
Investigator: Thomas E. Witzig, MD Mayo Clinic
Investigator: John A. Lust, MD, PhD Mayo Clinic
Investigator: Martha Q. Lacy, MD Mayo Clinic
Investigator: Angela Dispenzieri, MD Mayo Clinic
Investigator: S. V. Rajkumar, MD Mayo Clinic
Investigator: Steve Zeldenrust, MD Mayo Clinic
Investigator: Suzanne Hayman, MD Mayo Clinic
Investigator: Rafael Fonseca, MD Mayo Clinic Scottsdale
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000546657, MAYO-MC058E, MAYO-06-002786
Study First Received: May 23, 2007
Last Updated: January 7, 2009
ClinicalTrials.gov Identifier: NCT00478218     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Study placed in the following topic categories:
Anti-Inflammatory Agents
Dexamethasone
Immunologic Factors
Blood Protein Disorders
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Cyclophosphamide
Hemostatic Disorders
Hormones
Hemorrhagic Disorders
Alkylating Agents
Dexamethasone acetate
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Lenalidomide
Immunosuppressive Agents
Glucocorticoids
Multiple Myeloma
Antineoplastic Agents, Alkylating
Peripheral Nervous System Agents
Lymphoproliferative Disorders
Antirheumatic Agents
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Dexamethasone
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Cyclophosphamide
Hemostatic Disorders
Hormones
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Alkylating Agents
Dexamethasone acetate
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Hematologic Diseases
Gastrointestinal Agents
Vascular Diseases
Lenalidomide
Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Multiple Myeloma

ClinicalTrials.gov processed this record on May 07, 2009