Phase I/II Trial of Allogeneic Peripheral Blood Stem Cell Transplantation Followed by Maintenance Therapy With Lenalidomide and Sirolimus in Patients With High-Risk Multiple Myeloma
- 1. Understand and voluntarily sign an informed consent form.
- 2. Age 18-70 years at the time of signing the informed consent form.
- 3. Able to adhere to the study visit schedule and other protocol requirements.
- 4. Previously documented multiple myeloma (MM) with measurable monoclonal protein by
either serum/urine protein electrophoresis or serum free light chains, or measurable
- 5. ECOG performance status of 0-2 at study entry (see Appendix 2).
- 6. Acceptable organ function as outlined in the protocol.
- 7. Otherwise fitting institutional criteria for allogeneic stem cell transplantation.
- 8. Presence of an HLA-matched (5/6 or 6/6 matched for HLA-A, B, and DR) sibling
donor, or a HLA-matched (matched for at least HLA-A, B, C, and DRB1) unrelated donor
by high-resolution testing.
- 9. Disease free of prior malignancies for >/= 5 years with exception of currently
treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the
cervix or breast.
- 10. All study participants must be registered into the mandatory RevAssist® program,
and be willing and able to comply with the requirements of RevAssist®.
- 11. Females of childbearing potential (FCBP) must have a negative serum or urine
Recipient Exclusion Criteria:
- 1. Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form.
- 2. Pregnant or breast feeding females.
- 3. 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.
- 4. Known hypersensitivity to thalidomide or Lenalidomide.
- 5. The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs.
- 6. Known seropositive for or active viral infection with human immunodeficiency virus
(HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are
seropositive because of hepatitis B virus vaccine or prior infection to which they
are now immune (i.e., not carriers) are eligible.
The following categories of donor will be acceptable:
- 1. HLA-matched related donor (5/6 or 6/6 match): Minimal typing necessary is
serologic typing for class I (A, B) and molecular typing for class II (DRB1).
- 2. HLA-matched Unrelated Donor (MUD): Molecular identity at least at HLA A, B, C, and
DRB1 and DQB1 (8/10 match) by high resolution typing is required.
- 3. Syngeneic donors are not eligible.
- 4. The donor must be healthy and must be an acceptable donor as per institutional
standards for marrow or stem cell donation.
- 5. Age ≥ 18 years