Allo Transplant Followed by Lenalidomide and Sirolimus Maintenance in High-Risk Multiple Myeloma (MM)

NCT ID: NCT01303965

Last Updated: 2019-01-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-07
• Study Completion Date: 2017-07-28

Brief Summary

One of the complications that can occur after a stem cell transplant is called graft versus host disease (GVHD). Another complication is that multiple myeloma may come back (relapse). In this study, a drug called lenalidomide will be started 1-2 months after a transplant, or possibly later depending on recovery of your side effects. Lenalidomide and sirolimus have been shown to work together against multiple myeloma. Therefore, lenalidomide will be combined with sirolimus with the hope that this will help prolong the amount of time the disease is in remission. Researchers hope these steps will help prolong the amount of time the multiple myeloma is in remission and will decrease the chance of GvHD.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open Label, Single Arm

Use sirolimus and tacrolimus as GvHD prophylaxis with sirolimus and lenalidomide as post-transplant maintenance

Group Type: EXPERIMENTAL

Sirolimus

Intervention Type: DRUG

Start on Day -3 and continue for 1 year

Tacrolimus

Intervention Type: DRUG

Start on Day -3 and begin tapering on Day +100 until Day +180.

Lenalidomide

Intervention Type: DRUG

Start between Day +30 and +120 and continue for 1 year.

Interventions

Sirolimus

Start on Day -3 and continue for 1 year

Intervention Type: DRUG

Tacrolimus

Start on Day -3 and begin tapering on Day +100 until Day +180.

Intervention Type: DRUG

Lenalidomide

Start between Day +30 and +120 and continue for 1 year.

Intervention Type: DRUG

Eligibility Criteria

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 plasmacytomas.
• 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

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

Sherif S. Farag

OTHER

Sponsor Role: lead

Responsible Party

Sherif S. Farag

Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sherif Farag, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IU Simon Cancer Center

Locations

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

1012-24; IUCRO-0307

Identifier Type: -

Identifier Source: org_study_id