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Lenalidomide and Melphalan in Treating Patients With Previously Untreated 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: NCT00305812
Recruitment Status : Completed
First Posted : March 22, 2006
Last Update Posted : November 9, 2010
Information provided by:
Canadian Cancer Trials Group

Brief Summary:

RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as melphalan, 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 melphalan may kill more cancer cells.

PURPOSE: This randomized phase II trial is studying the side effects and best dose of lenalidomide when given together with melphalan and to see how well they work in treating patients with multiple myeloma.

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

Detailed Description:



  • Evaluate the tolerability of 2 different doses of lenalidomide when administered with melphalan in patients with previously untreated multiple myeloma who are not planning to undergo future autologous stem cell transplantation.


  • Characterize the toxicity profile of lenalidomide in combination with melphalan.
  • Determine tumor response in these patients after 2 and 12 courses of induction therapy with lenalidomide and melphalan and after 6 months of maintenance therapy with dexamethasone.
  • Determine progression-free and overall survival of these patients.
  • Determine time to dose modification and time to dose discontinuation in these patients.


  • Examine wnt pathway inhibition in response to lenalidomide on pre- and post-treatment bone marrow and blood samples using enzyme-linked immunosorbent assay (ELISA), gene expression profiling, drosophila-based chemical genetics, and surface-enhanced laser desorption/ionization mass spectrometry (SELDI MS) proteomics.

OUTLINE: This is a multicenter, randomized, open-label, dose-finding study of lenalidomide.

Prior to randomization, 6 patients receive oral lenalidomide at a lower dose (same dose to be used in arm I) once daily on days 1-21 and oral melphalan once daily on days 1-4. Treatment repeats every 28 days for 3 courses. If no unacceptable toxicity occurs, the trial will proceed and randomization will occur.

  • Induction therapy: Patients are randomized to 1 of 2 dose levels of lenalidomide.

    • Arm I: Patients receive oral lenalidomide once daily on days 1-21 and oral melphalan once daily on days 1-4.
    • Arm II: Patients receive oral lenalidomide as in arm I, but at a lower dose, and melphalan as in arm I, but at a higher dose.

Treatment in both arms repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After 12 courses of induction therapy, patients in both arms without progressive disease proceed to maintenance therapy.

  • Maintenance therapy: Patients receive oral dexamethasone once daily on days 1-4. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 4 weeks and then every 2 months thereafter.

PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Dose Finding Study of Revlimid™ and Melphalan in Patients With Previously Untreated Multiple Myeloma
Study Start Date : December 2005
Actual Study Completion Date : June 2008

Primary Outcome Measures :
  1. Incidence of dose-limiting toxicity within first 3 courses of treatment

Secondary Outcome Measures :
  1. Toxicity
  2. Disease response after 2 courses, 6 courses, 12 courses, and 6 months of maintenance therapy
  3. Time to progression
  4. Overall survival
  5. Duration of disease-free interval
  6. Time to dose modification
  7. Time to dose discontinuation

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


  • Histologically confirmed multiple myeloma by one of the following:

    • Biopsy of an osteolytic lesion or soft tissue tumor composed of plasma cells
    • Bone marrow aspirate and/or biopsy demonstrating ≥ 10% plasmacytosis
    • Bone marrow < 10% plasma cells but with ≥ 1 bony lesion AND meets the M-protein criteria
  • Ineligible for stem cell transplantation due to any of the following:

    • Advanced age
    • Comorbid illness
    • Patient preference
  • Previously untreated disease
  • Measurable (i.e., quantifiable) serum M-component of IgG, IgA, IgD, or IgE at initial diagnosis OR, if only light-chain disease is present (urine M-protein only), urinary excretion of light-chain protein (Bence Jones) ≥ 1.0 g/24 hours at initial diagnosis

    • No nonsecretory myeloma


  • ECOG performance status 0-2
  • Life expectancy ≥ 12 months
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 150,000/mm^3
  • Creatinine ≤ 3 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • AST and/or ALT ≤ 1.5 times ULN
  • Alkaline phosphatase ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 methods of effective contraception during and for 4 weeks after completion of study treatment
  • No other malignancies within the past 5 years, except adequately treated nonmelanoma skin cancer or curatively treated in situ cancer of the cervix
  • No hypersensitivity to thalidomide or its components, including the development of a desquamating rash
  • No other serious illness or medical condition that would preclude study participation
  • No history of significant neurologic or psychiatric disorder that would preclude informed consent
  • No known HIV positivity
  • No pre-existing cardiovascular conditions and/or symptomatic cardiac dysfunction, including any of the following:

    • Significant cardiac event (including symptomatic heart failure or angina) within 3 months prior to randomization
    • Any cardiac disease that increases risk for ventricular arrhythmia
    • History of ventricular arrhythmia that was symptomatic or required treatment, including any of the following:

      • Multifocal premature ventricular contractions
      • Bigeminy
      • Trigeminy
      • Ventricular tachycardia/fibrillation/flutter/arrhythmia NOS


  • No prior chemotherapy or corticosteroids for the treatment of multiple myeloma

    • Prior corticosteroids for the treatment of hypercalcemia or spinal cord compression allowed provided maximum levels have not been reached (i.e.,< 120 mg for dexamethasone or < 792 mg for prednisone)
  • Prior radiotherapy to single sites for pain control or local plasmacytoma allowed
  • Prior or concurrent bisphosphonates allowed
  • At least 28 days since prior investigational anticancer agents or therapy
  • No concurrent corticosteroids above physiologic replacement doses
  • Concurrent radiotherapy to sites of active myeloma with pain or neurologic compromise allowed
  • No concurrent filgrastim (G-CSF) on day 1 of course 1
  • No other concurrent anticancer therapy
  • No other concurrent investigational therapy

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): NCT00305812

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Canada, Alberta
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
Canada, New Brunswick
Moncton Hospital
Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Algoma District Cancer Program at Sault Area Hospital
Sault Ste. Marie, Ontario, Canada, P6A 2C4
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Humber River Regional Hospital - Weston
Toronto, Ontario, Canada, M9N 1N8
Canada, Quebec
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada, H2W 1S6
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Sponsors and Collaborators
NCIC Clinical Trials Group
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Study Chair: Darrell White, MD Nova Scotia Cancer Centre

Publications of Results:
White DJ, Bahlis NJ, Marcellus DC, et al.: Phase II testing of lenalidomide plus melphalan for previously untreated older patients with multiple myeloma: the NCIC CTG MY.11 trial. [Abstract] Blood 112 (11): A-2767, 2008.
White DJ, Kovacs MJ, Belch A, et al.: Phase II testing of lenalidomide plus melphalan for previously untreated older patients with multiple myeloma: toxicity data from the NCIC CTG MY.11 trial. [Abstract] Blood 110 (11): A-189, 2007.

Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00305812     History of Changes
Other Study ID Numbers: MY11
CDR0000466184 ( Other Identifier: PDQ )
First Posted: March 22, 2006    Key Record Dates
Last Update Posted: November 9, 2010
Last Verified: March 2010

Keywords provided by Canadian Cancer Trials Group:
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
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors