Lenalidomide and High-Dose Melphalan
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
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.
Stem Cell Transplantation
Procedure: Stem Cell Infusion
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase I/II Study Of The Combination Of Lenalidomide With High-Dose Melphalan For Autologous Transplant in Patients With Multiple Myeloma
Primary Outcome Measures:
- Maximum Tolerated Dose (MTD) of Lenalidomide [ Time Frame: 21-28 Day Cycles ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||March 2016 (Final data collection date for primary outcome measure)
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.
Beginning dose level 25 mg by mouth (PO) on Days -8 to -2
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.
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- Age 18 to 80 years
- Performance score of at least 80% by Karnofsky or performance score of 0 or 1 (ECOG)
- Left ventricular ejection fraction =/> 40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- FEV1, FVC and DLCO=/> 40%. No symptomatic pulmonary disease.
- 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.
- Creatinine Clearance =/> 50 ml/min
- HIV negative
- Negative beta HCG test in women with child bearing potential, defined as not post-menopausal for 24 months or no previous sterilization.
- Patients or guardian able to sign informed consent.
- All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
- 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.
- 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.
- Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment.
- Patients with uncontrolled hypertension (systolic > 140, diastolic >90 despite anti-hypertensive therapy.)
- Patients with uncontrolled bacteria, viral or fungal infections (currently taking medication and progression of clinical symptoms).
- Known hypersensitivity or desquamating rash to either thalidomide or lenalidomide.
- 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.)
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01079936
|UT MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
M.D. Anderson Cancer Center
||Muzaffar H. Qazilbash, MD
||UT MD Anderson Cancer Center
No publications provided
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 2, 2010
||May 23, 2014
||United States: Institutional Review Board
Keywords provided by M.D. Anderson Cancer Center:
Autologous stem cell transplantation
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 28, 2014
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Angiogenesis Modulating Agents