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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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

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


Inclusion Criteria:

- 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
pregnancy test

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.


Inclusion Criteria:

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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with Dose Limiting Toxicities as a Measure of Safety of the combination of sirolimus, tacrolimus and lenalidomide

Outcome Description:

Determine the safety of reduced-intensity allogeneic stem cell transplantation using sirolimus and tacrolimus as GvHD prophylaxis with sirolimus and lenalidomide as post-transplant maintenance in an initial Phase I component of the study

Outcome Time Frame:

1 year post transplantation

Safety Issue:


Principal Investigator

Sherif Farag, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

IU Simon Cancer Center


United States: Institutional Review Board

Study ID:

1012-24; IUCRO-0307



Start Date:

February 2011

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289