A Trial Comparing Single Agent Melphalan to Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) as a Preparative Regimen for Patients With Multiple Myeloma Undergoing High Dose Therapy Followed by Autologous Stem Cell Reinfusion (BEAM)

This is an interventional treatment trial for Multiple Myeloma Read More

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