Samarium Sm 153 Lexidronam Pentasodium and High-Dose Melphalan in Treating Patients With Multiple Myeloma Undergoing Stem Cell Transplant

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing. Samarium Sm 153 lexidronam pentasodium contains a radioactive substance that kill cancer cells. Peripheral blood stem cell transplant using stem cells from the patient may be able to replace immune cells that were destroyed by chemotherapy and radioactive drugs used to kill cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of samarium Sm 153 lexidronam pentasodium when given together with high-dose melphalan in treating patients with multiple myeloma undergoing stem cell transplant.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Melphalan; Samarium ethylenediaminetetramethylenephosphonate; Samarium Sm-153 lexidronam; Sargramostim

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of multiple myeloma requiring treatment

• Must have at least 2 x 10^6 CD34+ cells collected for peripheral blood stem cell transplantation

PATIENT CHARACTERISTICS:

Inclusion criteria:

• ECOG performance status (PS) 0-2 (ECOG PS > 2 allowed if secondary to neuropathy or acute bone event)

• Direct bilirubin ≤ 2.0 mg/dL

• Alkaline phosphatase ≤ 750 μ/L

• Creatinine ≤ 3.0 mg/dL

• Ejection fraction ≥ 45%

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception for 6 months after the completion of study therapy

Exclusion criteria:

• DLCO < 50%

• FVC < 50%

• FEV_1 < 50%

• Active malignancy with the exception of nonmelanoma skin cancer

• Uncontrolled infection

• NYHA class III-IV cardiac disease

PRIOR CONCURRENT THERAPY:

• May or may not have received prior chemotherapy

• At least 3 weeks since prior chemotherapy

• Cyclophosphamide pulsing for stem cell collection allowed

• At least 4 weeks since prior biologic therapy

• At least 2 weeks since prior bisphosphonates and bisphosphonates maybe resumed 1 month post-study treatment