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
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Hematology, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 10/5/2018 |
| Start Date: | September 5, 2018 |
| End Date: | December 2021 |
| Contact: | Janell Duey, JD |
| Email: | Janell.Duey@swedish.org |
| Phone: | 206-386-2572 |
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
The work proposed herein aims to provide the first prospective, randomized comparative
efficacy data between Melphalan and BEAM treatment regimen in the Multiple Myeloma (MM)
patient population. The risk of such a study is deemed reasonable and ethical since: a)
previous works have closely examined the safety and toxicity of the BEAM regimen and the
doses to be delivered in this protocol are well below the toxicity levels; b) phase III
trials of BEAM have provided reasonable data regarding the efficacy in lymphomas c) Early,
retrospective data suggests that BEAM may be efficacious in MM however due to the lack of
prospective controlled randomized clinical trial, there is adequate equipoise regarding its
efficacy and moreover its comparative efficacy in relation to Melphalan and; D) there are
known limitations in the standard-of-care for MM, Melphalan, namely, relatively low rates of
complete response at the time of Autologous stem-cell transplantation (ASCT) and poor
progression free survival.
efficacy data between Melphalan and BEAM treatment regimen in the Multiple Myeloma (MM)
patient population. The risk of such a study is deemed reasonable and ethical since: a)
previous works have closely examined the safety and toxicity of the BEAM regimen and the
doses to be delivered in this protocol are well below the toxicity levels; b) phase III
trials of BEAM have provided reasonable data regarding the efficacy in lymphomas c) Early,
retrospective data suggests that BEAM may be efficacious in MM however due to the lack of
prospective controlled randomized clinical trial, there is adequate equipoise regarding its
efficacy and moreover its comparative efficacy in relation to Melphalan and; D) there are
known limitations in the standard-of-care for MM, Melphalan, namely, relatively low rates of
complete response at the time of Autologous stem-cell transplantation (ASCT) and poor
progression free survival.
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
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