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Lenalidomide With or Without Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Mayo Clinic
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00772915
  Purpose

RATIONALE: Lenalidomide and dexamethasone may stop the growth of multiple myeloma by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well lenalidomide works with or without dexamethasone in treating patients with newly diagnosed multiple myeloma.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: dexamethasone
Drug: lenalidomide
Procedure: bone marrow aspiration
Procedure: flow cytometry
Procedure: immunohistochemistry staining method
Procedure: laboratory biomarker analysis
Procedure: pharmacological study
Procedure: staining method
Phase II

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

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

Primary Outcome Measures:
  • Progression-free survival rate at 1 year [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Parameter of immune activation in lenalidomide alone [ Designated as safety issue: No ]
  • Global parameters of immune function and levels of antibodies [ Designated as safety issue: No ]
  • Antiangiogenesis activity [ Designated as safety issue: No ]
  • Cell proliferation levels [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]

Estimated Enrollment: 39
Study Start Date: December 2008
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

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

Tertiary

  • 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 dexamethasone.
  • 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 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 3 years.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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 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: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

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772915

Locations
United States, Minnesota
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Shaji K. Kumar, MD Mayo Clinic
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: Francis K. Buadi, MD Mayo Clinic
Investigator: David Dingli, MD Mayo Clinic
Investigator: Stephen J. Russell, MD, PhD Mayo Clinic
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: Mayo Clinic Cancer Center ( Clinical Trials Office )
Study ID Numbers: CDR0000616057, MAYO-MC0884, MAYO-08-002093
Study First Received: October 12, 2008
Last Updated: December 5, 2008
ClinicalTrials.gov Identifier: NCT00772915  
Health Authority: Unspecified

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:
Dexamethasone
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Lenalidomide
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Dexamethasone acetate
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics
Hormones
Glucocorticoids
Pharmacologic Actions
Neoplasms
Autonomic Agents
Therapeutic Uses
Cardiovascular Diseases
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009