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
  • End date
    Dec 13, 2021
  • participants needed
    100
  • sponsor
    Swedish Medical Center
Updated on 13 March 2021
calcium
anemia
lymphoma
ejection fraction
monoclonal antibodies
melphalan
cell transplantation
bone marrow procedure
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, Lymphoproliferative Disorder, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment cytarabine, etoposide, melphalan, carmustine, Allopurinol
Clinical Study IdentifierNCT03570983
SponsorSwedish Medical Center
Last Modified on13 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Gender: Male or Female
Do you have Multiple Myeloma?
Do you have any of these conditions: multiple myeloma (mm) or Lymphoproliferative Disorder or Lymphoproliferative disorders or Multiple Myeloma?
Do you have any of these conditions: Lymphoproliferative disorders or multiple myeloma (mm) or Lymphoproliferative Disorder or Multiple Myeloma?
Do you have any of these conditions: Multiple Myeloma or Lymphoproliferative Disorder or Lymphoproliferative disorders or multiple myeloma (mm)?
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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