Clinical Trial Finder

Inclusion Criteria:

1. Patients who have a new diagnosis of MM according to the International Myeloma Working Group (IMWG) working criteria undergoing autologous or syngeneic hematopoietic transplantation. According to these criteria, the following must be met: 1. Monoclonal plasma cells in the bone marrow > 10% (or proven plasmacytic infiltration in bone marrow biopsy) and/or presence of a biopsy-proven plasmacytoma. 2. Monoclonal protein (M-protein) present in the serum and/or. 3. Myeloma-related organ dysfunction (1 or more) of the following. A variety of other types of end-organ dysfunctions can occasionally occur and lead to a need for therapy:

• - [C] Calcium elevation in the blood, defined as serum calcium > 10.5 mg/dl or upper limit of normal [R] Renal insufficiency (defined as serum creatinine above normal) [A] Anemia, defined as hemoglobin < normal - [B] Lytic bone lesions or osteoporosis.

If a solitary (biopsy-proven) plasmacytoma or osteoporosis alone (without fractures) are the sole defining criteria, then > 30% plasma cells are required in the bone marrow. 2. Patients must have received initial therapy for MM; at least 2 cycles with a minimum of partial response as defined by IMWG guidelines. 3. Age >=18, < 70years. 4. Karnofsky >70. 5. Life expectancy is not severely limited by concomitant illness based on the Hematopoietic Cell Transplant Comorbidity Index (HCT-CI) [8, 9] including: 1. Left ventricular ejection fraction >50%. No uncontrolled arrhythmias or symptomatic cardiac disease. 2. FEV1, FVC and DLCO >50%. No symptomatic pulmonary disease. 3. HIV-negative. 4. Bilirubin <2 mg/dl, SGPT <2.5 x normal. 5. Creatinine clearance > 50 cc/min, estimated or measured. 6. Proficient in English. 7. Signed informed consent.

Exclusion Criteria:

1. Pregnant or lactating females. 2. Limited verbal or reading English proficiency. 3. Insufficient cognitive or comprehensive capability to provide informed consent. 4. Uncontrolled infection. 5. Planned tandem autologous/reduced intensity allograft. 6. Insufficient peripheral blood stem cells (PBSC) in storage for an autologous transplant (<4.0 x 106 CD34+ cells/kg total). 7. Prior autologous transplant. 8. Patients unwilling to practice adequate forms of contraception if clinically indicated. Male patients on study need to be consulted to use latex condoms even if they have had a vasectomy every time they have sex with a woman who is able to have children. 9. Patients with history of seizures. 10. Prior history of another malignancy with a life expectancy of <3 years. 11. Known amyloidosis. 12. Uncontrolled CNS myeloma. 13. Anesthesia Society of America Physical Status (ASA PS) of 4 or greater

Arms

Experimental: BEAM Regimen- Experimental Arm

Allopurinol Dosage: Allopurinol 200 mg/m2/day starts on the day prior to BCNU, day -8 and stops on day -1. BCNU (Carmustine) Dosage: Carmustine 300 mg/m2 IV x 1 will be infused over 3 hours on autografting day -7. Carmustine should not be infused with solutions or tubing containing or previously containing bicarbonate solution. Etoposide (VP-16, Vepesid) Dosage: Etoposide 100 mg/m2 IV BID will be administered in 500-1000 cc normal saline over 2 hours on autografting days -6, -5, -4, and -3 for a total dose of 800 mg/m2. Etoposide may not be infused with sodium bicarbonate solutions. Cytarabine (Ara-C) Dosage: Cytarabine 100 mg/m2 IV BID will be infused over 3 hours on autografting days -6, -5, -4 and -3.

Active Comparator: Melphalan Regimen- Control Arm

Melphalan Dosage: Melphalan will be administered at a dose of 200 mg/m2 IV x 1 infused over 30 minutes on autografting day -2. Allopurinol Dosage: Allopurinol 200 mg/m2/day starts on the day prior to melphalan (day -3) and stops on day -1.

Interventions

Drug: - Allopurinol

Dosage: Allopurinol 200 mg/m2/day starts on the day prior to BCNU, day -8 and stops on day -1.

Drug: - Carmustine

Dosage: Carmustine 300 mg/m2 IV x 1 will be infused over 3 hours on autografting day -7. Carmustine should not be infused with solutions or tubing containing or previously containing bicarbonate solution.

Drug: - Etoposide

Dosage: Etoposide 100 mg/m2 IV BID will be administered in 500-1000 cc normal saline over 2 hours on autografting days -6, -5, -4, and -3 for a total dose of 800 mg/m2. Etoposide may not be infused with sodium bicarbonate solutions.

Drug: - Cytarabine

Dosage: Cytarabine 100 mg/m2 IV BID will be infused over 3 hours on autografting days -6, -5, -4 and -3. Availability and administration: Cytarabine is available in a reconstituted form in solutions containing 20, 50 and 100 mg of cytarabine per mL.

Drug: - Melphalan

Melphalan will be administered at a dose of 200 mg/m2 IV x 1 infused over 30 minutes on autografting day -2.