Lenalidomide and High-Dose Melphalan

• Register: ClinicalTrials.gov
• Last refreshed on: 7 January 2013
• Main ID: NCT01079936
• Date of registration: 02/03/2010
• Primary sponsor: M.D. Anderson Cancer Center
• Public title: Lenalidomide and High-Dose Melphalan
• Scientific title: Phase I/II Study Of The Combination Of Lenalidomide With High-Dose Melphalan For Autologous Transplant in Patients With Multiple Myeloma
• Date of first enrolment: March 2010
• Target sample size: 60
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01079936
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Muzaffar H. Qazilbash, MD

• Name: Muzaffar H. Qazilbash, MD
• Affiliation: UT MD Anderson Cancer Center

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Myeloma

Stem Cell Transplantation

Intervention(s)

Drug: Lenalidomide

Drug: Melphalan

Procedure: Stem Cell Infusion

Primary Outcome(s)

Maximum Tolerated Dose (MTD) of Lenalidomide [Time Frame: 21-28 Day Cycles]

Secondary ID(s)

2008-0661

Source(s) of Monetary Support

Please refer to primary and secondary sponsors