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Lenalidomide and High-Dose Melphalan

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: NCT01079936
Recruitment Status : Completed
First Posted : March 3, 2010
Results First Posted : June 6, 2016
Last Update Posted : June 6, 2016
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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 or disease Intervention/treatment Phase
Myeloma Stem Cell Transplantation Drug: Lenalidomide Drug: Melphalan Procedure: Stem Cell Infusion Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2010
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of Lenalidomide [ Time Frame: Assessed at 21-28 Day Cycle ]
    There were 4 doses of lenalidomide in the dose escalation phase: 25 mg, 50 mg, 75 mg, and 100 mg. The first 12 patients were treated at these dose levels (3 patients per level) and safety assessed at each level. The MTD dose level was to be the level at which participants at each lenalidomide dose level had no dose limiting toxicity (DLT). DLT defined as as regimen-related death, graft failure, grade 3 or 4 atrial fibrillation, grade 4 deep venous thrombosis, or pulmonary embolism before day 30 after auto-HCT. Each participant received a fixed dose of Melphalan plus one of the four doses 25, 50, 75 or 100 mg of Lenalidomide orally for each of 7 days, -8 to -2 pre transplant.

  2. Number of Participants With Response (CR at Day 90) [ Time Frame: Day 90 after stem cell transplant ]
    Response is defined as the event that the participant is alive with complete response (CR) at day 90 (+/-30 days). CR defined as: A) Absence of monoclonal protein in urine and serum when analyzed by immunofixation electrophoresis. B) The bone marrow should be normal by morphological examination with <5% plasma cells. There should be < 1% aneuploid light chain restricted population by flow cytometry for DNA/cIg. C) While healing of bone lesions not required, no new lytic lesion should appear. Further compression fracture of spine will be not considered as progressive disease.

  3. Number of Participants With Day 30 DLT (Overall Study, Phase I/Phase II) [ Time Frame: Day 30 following transplant ]
    Dose limiting toxicity (DLT) was defined as regimen-related death, graft failure, grade 3 or 4 atrial fibrillation, grade 4 deep venous thrombosis, or pulmonary embolism before day 30 after auto-HCT.

  4. Participants With Grade 3 =/> Adverse Events [ Time Frame: Day 90 after stem cell transplant ]
    Number of participants experiencing adverse events above a Grade 3 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 2.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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): NCT01079936

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

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01079936     History of Changes
Other Study ID Numbers: 2008-0661
NCI-2011-00561 ( Registry Identifier: NCI CTRP )
First Posted: March 3, 2010    Key Record Dates
Results First Posted: June 6, 2016
Last Update Posted: June 6, 2016
Last Verified: May 2016
Keywords provided by M.D. Anderson Cancer Center:
Multiple Myeloma
Autologous stem cell transplantation
High-dose chemotherapy
Additional relevant MeSH terms:
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Neoplasms, Plasma Cell
Multiple Myeloma
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
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Immunosuppressive Agents