Clinical trial NCT01303965: Allo Transplant Followed by Lenalidomide and Sirolimus Maintenance in High-Risk Multiple Myeloma (MM)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2011-02-25
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Recipient 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

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.

Donor 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

Primary outcomes:
measure: Phase I: Number of Participants With Dose Limiting Toxicity
timeFrame: 28 days
measure: Phase II: Percent of Patients Alive and Free of Progression at 12 Months Following Transplant
timeFrame: Transplant (Day 0) through 1 year post-transplant
Secondary outcomes:
measure: Phase II - Percent of Patients With Acute Graft Versus Host Disease (GvHD)
timeFrame: Day 0 through 1 year post transplantation
measure: Phase II - Percent of Patients With Chronic Graft Versus Host Disease (GvHD)
timeFrame: Transplant (Day 0) through 1 year post-transplant
measure: Phase II - Percent of Patients With Treatment-related Deaths at 100 Days
timeFrame: 100 days post transplant
measure: Phase II - Percent of Patients With Treatment-related Deaths at 1 Year
timeFrame: Transplant (Day 0) through 1 year post-transplant
measure: Phase II - Time to Neutrophil Engraftment
timeFrame: Transplant (Day 0) through 1 year post transplant
measure: Phase II - Time to Platelet Engraftment
timeFrame: Transplant (Day 0) through 1 year post-transplant
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
Study officials:
affiliation: IU Simon Cancer Center
name: Sherif Farag, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: