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)

STATUS

Recruiting
End date

Dec 10, 2024
participants needed

100
sponsor

Swedish Medical Center

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Updated on 10 July 2022

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calcium

anemia

lymphoma

ejection fraction

monoclonal antibodies

melphalan

cell transplantation

bone marrow procedure

etoposide

monoclonal protein

serum calcium

plasmacytoma

Summary

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.

Details

Condition	Multiple Myeloma
Treatment	cytarabine, etoposide, melphalan, carmustine, Allopurinol
Clinical Study Identifier	NCT03570983
Sponsor	Swedish Medical Center
Last Modified on	10 July 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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
	Monoclonal plasma cells in the bone marrow > 10% (or proven plasmacytic infiltration in bone marrow biopsy) and/or presence of a biopsy-proven plasmacytoma
	Monoclonal protein (M-protein) present in the serum and/or
	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
	Patients must have received initial therapy for MM; at least 2 cycles with a minimum
	of partial response as defined by IMWG guidelines
	Age >=18, < 70years
	Karnofsky >70\
	Life expectancy is not severely limited by concomitant illness based on the Hematopoietic Cell Transplant Comorbidity Index (HCT-CI) [8, 9] including
	Left ventricular ejection fraction >50%. No uncontrolled arrhythmias or symptomatic cardiac disease
	FEV1, FVC and DLCO >50%. No symptomatic pulmonary disease
	HIV-negative
	Bilirubin <2 mg/dl, SGPT <2.5 x normal
	Creatinine clearance > 50 cc/min, estimated or measured
	Proficient in English
	Signed informed consent
Exclusion Criteria
	Pregnant or lactating females
	Limited verbal or reading English proficiency
	Insufficient cognitive or comprehensive capability to provide informed consent
	Uncontrolled infection
	Planned tandem autologous/reduced intensity allograft
	Insufficient peripheral blood stem cells (PBSC) in storage for an autologous transplant (<4.0 x 106 CD34+ cells/kg total)
	Prior autologous transplant
	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
	Patients with history of seizures
	Prior history of another malignancy with a life expectancy of <3 years
	Known amyloidosis
	Uncontrolled CNS myeloma
	Anesthesia Society of America Physical Status (ASA PS) of 4 or greater

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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)