Lenalidomide Plus Melphalan as a Preparative Regimen for Autologous Stem Cell Transplantation in Relapsed Multiple Myeloma: A Phase 1 / 2 Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01054196
Recruitment Status : Recruiting
First Posted : January 22, 2010
Last Update Posted : February 28, 2018
Information provided by (Responsible Party):
Weill Medical College of Cornell University

January 19, 2010
January 22, 2010
February 28, 2018
August 2010
December 2022   (Final data collection date for primary outcome measure)
to determine MTD of lenalidomide that can be added to melphalan [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT01054196 on Archive Site
to determine response rate and duration of response [ Time Frame: 24 months ]
Same as current
Not Provided
Not Provided
Lenalidomide Plus Melphalan as a Preparative Regimen for Autologous Stem Cell Transplantation in Relapsed Multiple Myeloma: A Phase 1 / 2 Study
Lenalidomide Plus Melphalan as a Preparative Regimen for Autologous Stem Cell Transplantation in Relapsed Multiple Myeloma: A Phase 1 / 2 Study

A) Phase 1: To determine the maximal tolerated dose (MTD) of lenalidomide that can be safely added to high-dose melphalan prior to autologous stem cell transplantation (ASCT).

B) Phase 2: To determine whether the addition of high-dose lenalidomide to ASCT followed by maintenance standard-dose lenalidomide improves the response rate and duration of response for relapsed multiple myeloma (RMM).

Not Provided
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Multiple Myeloma
  • Drug: lenalidomide
    daily dose dependent on dose-escalation schedule
    Other Name: Revlimid
  • Drug: melphalan
    100 mg/m2 given Days -2 and -1
Experimental: all patients
subjects will receive daily doses of lenalidomide starting on Day -5 of transplant and melphalan on Days -2 and -1.
  • Drug: lenalidomide
  • Drug: melphalan
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2025
December 2022   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed relapsed, primary refractory, or relapsed and refractory multiple myeloma.
  • Patients must have measurable disease as defined by the International Uniform Response Criteria,defined as any of the following:

    • serum M-protein of > = 500mg/dL
    • urine M-protein of > = 200mg/ 24 hours
    • involved free light chain > = 10mg/dL provided serum free light chain ratio is abnormal
  • Patients must have received at least one prior line of therapy.
  • Age > = 18 years.
  • Life expectancy of greater than 12 weeks.
  • ECOG performance status > = 2.
  • All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist.
  • Patients must have normal organ and marrow function as defined below:

    • ANC > = 1,000/uL
    • platelets > = 50,000/uL
    • total bilirubin < = 1.5 X upper limit of normal
    • AST(SGOT)/ALT(SGPT) < = 2.5 X upper limit of normal
    • Cardiac Ejection Fraction > = 45 %
    • Creatinine clearance > 60 cc/min
  • Patients must have an adequate number of CD34+ stem cells collected to allow for transplantation. This number is defined as ≥ 2 x 106 CD34+ cells / kg body weight. If not previously collected and stored, the patient must be willing to undergo stem cell mobilization and collection as per standard practice.
  • The effects of lenalidomide on the developing human fetus at the recommended therapeutic dose are unknown; however, it has been shown to be teratogenic other primates. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. The treating physician will follow the adverse reporting guidelines as outlined in further detail below for pregnancies.
  • Lenalidomide has been shown to carry a risk of thromboembolic events, especially when used in combination with either corticosteroids or alkylating chemotherapeutic agents. All patients who participate in this study must be willing and able to tolerate prophylactic anticoagulation with low-molecular weight heparin (LMWH) for the required dates in treatment protocol. Patients also must be able to tolerate low-dose aspirin, 81 mg daily, during the maintenance phase of the treatment protocol.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients who have had myeloma therapy within 14 days prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier. Patients may have received bisphosphonate therapy as part of routine myeloma care at any time prior to study entry.
  • Patients may not be receiving any other investigational agents.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to lenalidomide (including thalidomide) or melphalan.
  • Known positive for HIV or infectious hepatitis, type B or C.
  • Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown.
  • History of thrombosis or thromboembolic event within last 60 days prior to study entry.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact: Linda Tegnestam, RN 646-962-6500
United States
Not Provided
Not Provided
Weill Medical College of Cornell University
Weill Medical College of Cornell University
Principal Investigator: Roger Pearse, MD Weill Medical College of Cornell University
Weill Medical College of Cornell University
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP