A Phase I Dose Escalation Study of the Combination of Lenalidomide (Revlimid®), Dexamethasone and Cyclophosphamide in Patients Refractory or Relapsing From Stable Disease With Multiple Myeloma
1. Understand and voluntarily sign an informed consent form.
2. Age >18 years at the time of signing the informed consent form.
3. Proven diagnosis of multiple myeloma.
4. Relapse or Refractory disease with evidence of progression after at least 2 cycles of
5. Relapse or refractory disease with evidence of progressive disease after at least 1
previous therapy this may include consolidation of induction with a stem cell
6. Subjects may have been previously treated with thalidomide and/or radiation therapy.
In addition, radiation therapy initiated prior to or at baseline (Day 1) must be
complete prior to the initiation of therapy. The initiation of radiation therapy
after baseline (Day 1) will be considered to be a treatment failure (except when
given to treat or to promote the healing of a pathological fracture).
7. Measurable levels of myeloma paraprotein in serum (>5 gms/L) or urine > 2 g excreted
in a 24-hour collection sample).
8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
9. Able to adhere to the study visit schedule and other protocol requirements.
10. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy
test within 10 - 14 days and again within 24 hours of starting study drug. In
addition, sexually active WCBP must agree continued abstinence from heterosexual
intercourse or to use adequate contraceptive methods starting 4 weeks prior to the
initiation of therapy. WCBP must agree to have pregnancy tests weekly for the first 4
weeks, then monthly while on study drug (every 14 days for women with irregular
cycles) and 4 weeks after the last dose of study drug. Men must also agree to use a
condom if their partner is of child bearing potential, even if they have had a
11. Disease free of prior malignancies for equal to or over 5 years with exception of
currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma
"in-situ" of the cervix or breast.
12. Able to receive low dose aspirin (e.g. 75mg) as prophylactic anticoagulant medication
to prevent thromboembolism unless contraindicated. If low dose aspirin is
contraindicated, subjects will receive another form of anticoagulant prophylaxis
according to hospital guidelines.
1. Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form.
2. Pregnant or lactating females.
3. Any of the following laboratory abnormalities:
1. Absolute neutrophil count (ANC) <1.000 cells/mm3 (1.0 x 109/L)
2. Platelet count <.75.000/mm3 (75 x 109L)
3. Serum creatinine >2.5 mg/dL (221 umol/L)
4. Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
5. Serum total bilirubin >2.0 mg/dL (34 umol/L)
4. Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study.
5. Known hypersensitivity to thalidomide, dexamethasone or cyclophosphamide.
6. Prior history of uncontrollable side effects to dexamethasone therapy
7. The development of a desquamating rash while taking thalidomide
8. Any prior use of Lenalidomide (Revlimid®)
9. Use of any standard/experimental anti-myeloma drug therapy within 28 days of entry or
use of any experimental non-drug therapy (e.g. donor leukocyte/mononuclear cell
infusions) within 56 days of entry.