Combined Bone Marrow Transplantation (BMT) and Renal Transplant for Multiple Myeloma (MM) With End Stage Renal Disease (ESRD)

PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

August 31, 2001

Primary Completion Date

July 31, 2014

Study Completion Date

July 31, 2014

Conditions
Multiple MyelomaEnd Stage Renal Disease
Interventions
DRUG

Cyclophosphamide, anti-thymocyte globulin

"Cyclophosphamide 60 mg/kg IV on Day -5, -4 Anti-thymocyte globulin 20 mg/kg IV on Day -1, Day +1, +3, +5~Cyclosporine starting on Day -1 at 5 mg/kg daily I.V. and reduced to 3 mg/kg on Day +4, and adjusted to provide a trough whole blood concentration of 250-400 ng/mL. The route of administration will be changed to oral as soon as the patient is able to tolerate oral medications"

PROCEDURE

Kidney transplant

On Day 0 the renal transplant is performed according to standard surgical techniques, preferably using an iliac fossa, extraperitoneal approach

RADIATION

Thymic irradiation

Thymic irradiation 7 Gy on Day -1

PROCEDURE

Bone marrow transplant from a related donor

• Donor bone marrow (\> 2 x 108 nucleated cells/kg of recipient body weight) is prepared for infusion according to the standard procedure at the medical center. A total of 15,000 Units of heparin is mixed with the marrow, which is infused at a rate of 300-500 cc/hr. The infusion begins in the operating room as soon as the vascular anastomosis of the renal allograft has been completed. Protamine, 25 mg, is administered I.V. after completion of the first half of the bone marrow infusion. If a partial thromboplastin time measured after completion of the marrow infusion is \> 60 seconds, the protamine treatment shall be repeated

Trial Locations (1)

02114

Massachusetts General Hospital, Boston

All Listed Sponsors
lead

Massachusetts General Hospital

OTHER

NCT00854139 - Combined Bone Marrow Transplantation (BMT) and Renal Transplant for Multiple Myeloma (MM) With End Stage Renal Disease (ESRD) | Biotech Hunter | Biotech Hunter