Pharmacokinetic Study of Thalidomide in Subjects With Multiple Myeloma

Inclusion Criteria:

• Males and females ≥ at 18 the time of signing the informed consent document.

• Documented diagnosis of multiple myeloma and receiving thalidomide containing therapyor initiating thalidomide-containing therapy.

• Subjects must agree to temporally discontinue all antimyeloma therapies other than thestudy drug (thalidomide) at least 7 days prior to the PK phase (Day 1) and throughpost study procedures on Day 6.

• All Females of Child Bearing Potential (FCBP) and male subjects must be counseledabout pregnancy precautions and risks of fetal exposure.

• Females of childbearing potential (FCBP) must:

1. Have two negative pregnancy tests as verified by the study doctor prior tostarting study therapy. She must agree to ongoing pregnancy testing during thecourse of the study, and after end of study therapy. This applies even if thesubject practices true abstinence from heterosexual contact.

2. Either commit to true abstinence from heterosexual contact (which must bereviewed on a monthly basis) or agree to use, and be able to comply with,effective contraception without interruption, 28 days prior to starting studydrug, during the study therapy (including dose interruptions), and for 28 daysafter discontinuation of study therapy.

• All other females must had either a hysterectomy or bilateral oophorectomy at least 6months before screening (proper documentation required) OR been naturallypostmenopausal for at least 24 consecutive months (i.e. who has not had menses at anytime in the preceding 24 consecutive months). For this study, in subjects who arepostmenopausal, estradiol level must be <30 pg/mL and plasma FSH must be >40 IU/L atscreening.

• Males (including those who have had a vasectomy):

1. Must practice true abstinence or agree to use a condom during sexual contact witha pregnant female or a female of childbearing potential while participating inthe study, during dose interruptions and for at least 28 days following studydrug discontinuation, even if he has undergone a successful vasectomy.

2. Must agree to not donate semen and sperm during study drug therapy and for 4weeks after end of study drug therapy.

• All subjects must also be counseled against sharing thalidomide and donating bloodduring and within 4 weeks of discontinuing thalidomide therapy

Exclusion Criteria:

• Any significant medical condition, laboratory abnormality, or psychiatric illness thatwould prevent the subject from participating in the study (according to theThalidomide product/prescribing information).

• Any condition including the presence of laboratory abnormalities, which places thesubject at unacceptable risk if he/she were to participate in the study (according tothe Thalidomide product information).

• Any condition that confounds the ability to interpret data from the study (includesconditions that may affect the absorption of thalidomide, such as gastric bypasssurgery, colon resection, etc.).

• Pregnant or lactating females.

• Any surgical or medical conditions that might significantly alter the absorption ofstudy drug, such as gastrectomy, gastroenterostomy, bowel resection, pancreaticinjury, or pancreatitis. (Cholecystecomy and appendectomy are permissible.)

• Use of antimyeloma agents (other than thalidomide) or investigational agents within 7days before the start of the PK phase.

• Prior history of allergic reactions to thalidomide, thalidomide excipients (asreferenced in the IB), or to related drugs (ie, lenalidomide).

• Prior history of malignancies, other than multiple myeloma, unless the subject hasbeen free of the disease for >= 3 years (from the time of signing the ICD). Exceptionsinclude the following:

1. Basal cell carcinoma of the skin

2. Squamous cell carcinoma of the skin

3. Carcinoma in situ of the cervix

4. Carcinoma in situ of the breast

5. Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)

• Known human immunodeficiency virus (HIV) or infectious hepatitis (type A, B, or C)positivity.