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 : June 4, 2018
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:

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).

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: lenalidomide Drug: melphalan Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lenalidomide Plus Melphalan as a Preparative Regimen for Autologous Stem Cell Transplantation in Relapsed Multiple Myeloma: A Phase 1 / 2 Study
Actual Study Start Date : August 2010
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2025

Arm Intervention/treatment
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
daily dose dependent on dose-escalation schedule
Other Name: Revlimid

Drug: melphalan
100 mg/m2 given Days -2 and -1

Primary Outcome Measures :
  1. to determine MTD of lenalidomide that can be added to melphalan [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. to determine response rate and duration of response [ Time Frame: 24 months ]

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

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.

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): NCT01054196

Contact: Linda Tegnestam, RN 646-962-6500

United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Tomer Mark, MD    212-746-3964      
Principal Investigator: Tomer Mark, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Principal Investigator: Roger Pearse, MD Weill Medical College of Cornell University

Responsible Party: Weill Medical College of Cornell University Identifier: NCT01054196     History of Changes
Other Study ID Numbers: 0909010623
First Posted: January 22, 2010    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
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
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents, Alkylating
Alkylating Agents