Lenalidomide and High-Dose Melphalan

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
First received: March 2, 2010
Last updated: May 23, 2014
Last verified: May 2014

The goal of this clinical research study is to find the highest tolerable dose of the combination of Revlimid (lenalidomide) and high-dose Alkeran (melphalan) that can be given to patients with multiple myeloma who will receive an autologous stem cell transplantation. The safety of this combination therapy will also be studied.

Condition Intervention Phase
Stem Cell Transplantation
Drug: Lenalidomide
Drug: Melphalan
Procedure: Stem Cell Infusion
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study Of The Combination Of Lenalidomide With High-Dose Melphalan For Autologous Transplant in Patients With Multiple Myeloma

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) of Lenalidomide [ Time Frame: 21-28 Day Cycles ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: March 2010
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomide + High-Dose Melphalan
Lenalidomide beginning dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
Drug: Lenalidomide
Beginning dose level 25 mg by mouth (PO) on Days -8 to -2
Other Names:
  • Revlimid
  • CC-5013
Drug: Melphalan
Dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion
Other Name: Alkeran
Procedure: Stem Cell Infusion
Stem cell infusion on Day 0.

  Show Detailed Description


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with multiple myeloma with relapsed or progressive disease after achieving a partial or complete response to prior conventional therapy or autologous stem cell transplantation
  2. Age 18 to 80 years
  3. Performance score of at least 80% by Karnofsky or performance score of 0 or 1 (ECOG)
  4. Left ventricular ejection fraction =/> 40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
  5. FEV1, FVC and DLCO=/> 40%. No symptomatic pulmonary disease.
  6. Serum bilirubin <2 x upper limit of normal, SGPT <3x upper limit of normal. No evidence of chronic active hepatitis or cirrhosis. No pleural effusion or ascites > 1 L prior to drainage.
  7. Creatinine Clearance =/> 50 ml/min
  8. HIV negative
  9. Negative beta HCG test in women with child bearing potential, defined as not post-menopausal for 24 months or no previous sterilization.
  10. Patients or guardian able to sign informed consent.
  11. All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
  12. Females of childbearing potential (FCBP) must have a negative serum pregnancy test with a sensitivity of at least 50 mIU/mL within 10 -14 days prior to and again within 24 hours of 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 4 weeks before she starts taking lenalidomide.
  13. Contd. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with females of child bearing potential even if they have had a successful vasectomy. See Appendix F: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.

Exclusion Criteria:

  1. Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment.
  2. Patients with uncontrolled hypertension (systolic > 140, diastolic >90 despite anti-hypertensive therapy.)
  3. Patients with uncontrolled bacteria, viral or fungal infections (currently taking medication and progression of clinical symptoms).
  4. Known hypersensitivity or desquamating rash to either thalidomide or lenalidomide.
  5. Women who are pregnant (positive ß-HCG) or breastfeeding. (Lactating women must agree not to breast feed while taking lenalidomide and for 28 days after last dose of lenalidomide.)
  6. New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia's, or electrocardiographic evidence of acute ischemia, or a 2nd or 3rd degree AV block or new left bundle branch block on EKG.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01079936

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Study Chair: Muzaffar H. Qazilbash, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01079936     History of Changes
Other Study ID Numbers: 2008-0661, NCI-2011-00561
Study First Received: March 2, 2010
Last Updated: May 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Multiple Myeloma
Autologous stem cell transplantation
High-dose chemotherapy

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Vascular Diseases
Alkylating Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 21, 2014