Skip to content
Triangle logo TriangleGet started
← Study library

NCT02416206 · REGISTRY CONDITION SEARCH

High Dose Chemotherapy Using BeEAM for Autologous Transplant in Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2023-05-18

High-dose chemotherapy and autologous stem cell transplantation (ASCT) as part of the up-front treatment of patients with multiple myeloma has been associated with improved disease-free and overall survival in multiple large randomized controlled trials. Following 3-6 cycles of standard induction therapy with biologic agents, consolidation with high dose Melphalan and ASCT has become the standard-of-care approach for fit myeloma patients up to 70 years of age. Single-agent high-dose Melphalan (200mg/m2) is currently the standard-of-care preparative regimen prior to autologous transplant in Myeloma. Historical studies utilizing Busulfan- or Total Body Irradiation-based preparative regimens have yielded similar results to single-agent Melphalan with higher toxicity.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

To Estimate the Response at Day 100 Following Transplant (Rate of CR)

→

outcome · POSTED

Number of Patients With Overall Survival Post-transplant

→

outcome · POSTED

Number of Patients With Progression-free Survival

→

outcome · POSTED

Number of Patients Who Relapsed After Transplant

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria: * Age between 18 - 70 years * Karnofsky status ≥ 70% * Diagnosis of Multiple Myeloma * Within 9 months of the start of induction chemotherapy and no evidence of relapse or progression. * Availability of Cryopreserved peripheral blood stem cells with a CD34 dose of at least 2x106/kg. Exclusion Criteria: * Poor cardiac function: left ventricular ejection fraction \<40% * Poor pulmonary function: FEV1, FVC, or DLCO \<40% predicted * Poor liver function: bilirubin \>2.5 mg/dl (not due to hemolysis, Gilbert's or primary malignancy), AST/ALT \> 3X ULN * Poor renal function: Creatinine \>2.0 mg/dl or creatinine clearance \< 40 mL/min (calculated creatinine clearance is permitted) * Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive. * Women of childbearing potential who currently are pregnant or who are not practicing adequate contraception * Patients who have any debilitating medical or psychiatric illness which would preclude their giving informed consent or their receiving optimal treatment and follow-up.
healthy Volunteers
false
maximum Age
70 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Bendaumustine, Etoposide, Cytrabine and Melphalan in autologous transplant for multiple myeloma
    intervention Names
    1. Drug: BeEAM
    label
    BeEAM
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. BeEAM
    description
    BeEAM
    name
    BeEAM
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
65
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Using IMWG criteria: PR (partial response) noted as \>50% reduction of serum M-protein and reduction in 24hr urinary M-protein by \>90% or to \<200mg/24h; VgPR (very good partial response) noted as serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>90% reduction in serum M-protein plus urine M-protein level \<100mg/24h; CR (complete response) noted as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow; sCR (stringent complete response) noted as CR defined above plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
    measure
    To Estimate the Response at Day 100 Following Transplant (Rate of CR)
    time Frame
    Day 100
secondary Outcomes
  1. measure
    Number of Patients With Overall Survival Post-transplant
    time Frame
    3 years
  2. measure
    Number of Patients With Progression-free Survival
    time Frame
    3 years
  3. measure
    Number of Patients Who Relapsed After Transplant
    time Frame
    3 years
Full study description
brief Summary
High-dose chemotherapy and autologous stem cell transplantation (ASCT) as part of the up-front treatment of patients with multiple myeloma has been associated with improved disease-free and overall survival in multiple large randomized controlled trials. Following 3-6 cycles of standard induction therapy with biologic agents, consolidation with high dose Melphalan and ASCT has become the standard-of-care approach for fit myeloma patients up to 70 years of age. Single-agent high-dose Melphalan (200mg/m2) is currently the standard-of-care preparative regimen prior to autologous transplant in Myeloma. Historical studies utilizing Busulfan- or Total Body Irradiation-based preparative regimens have yielded similar results to single-agent Melphalan with higher toxicity.
detailed Description
Myeloma patients, following up-front induction therapy, will receive an ASCT following a high-dose bendamustine-based preparative regimen (BeEAM). The primary endpoint of this trial will be the rate of CR at day 100 post-transplant. Experience from the literature, as well as results from our institution, suggests that following ASCT for the upfront treatment of myeloma, the rate of CR at day 100 post-transplant is approximately 45%. It is hoped that under this protocol, this rate will be at least 65%. Thus we statistically formalize this study by testing the null hypothesis that p, the CR rate is 0.65 or more versus the alternative hypothesis that p is less than 0.45. A sample size of 65 pts gives 90% power with an alpha=0.05, using the formula for a one sample binomial (two-sided) test of a proportion.
Source references
references
  1. citation
    Attal M, Harousseau JL. The role of high-dose therapy with autologous stem cell support in the era of novel agents. Semin Hematol. 2009 Apr;46(2):127-32. doi: 10.1053/j.seminhematol.2009.02.006.
    pmid
    19389496
    type
    BACKGROUND
  2. citation
    Harousseau JL, Attal M, Divine M, Marit G, Leblond V, Stoppa AM, Bourhis JH, Caillot D, Boasson M, Abgrall JF, et al. Autologous stem cell transplantation after first remission induction treatment in multiple myeloma. A report of the French Registry on Autologous Transplantation in Multiple Myeloma. Stem Cells. 1995 Aug;13 Suppl 2:132-9. doi: 10.1002/stem.5530130721.
    pmid
    8520502
    type
    BACKGROUND
  3. citation
    Attal M, Harousseau JL, Stoppa AM, Sotto JJ, Fuzibet JG, Rossi JF, Casassus P, Maisonneuve H, Facon T, Ifrah N, Payen C, Bataille R. A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Francais du Myelome. N Engl J Med. 1996 Jul 11;335(2):91-7. doi: 10.1056/NEJM199607113350204.
    pmid
    8649495
    type
    BACKGROUND
  4. citation
    Harousseau JL, Avet-Loiseau H, Attal M, Charbonnel C, Garban F, Hulin C, Michallet M, Facon T, Garderet L, Marit G, Ketterer N, Lamy T, Voillat L, Guilhot F, Doyen C, Mathiot C, Moreau P. Achievement of at least very good partial response is a simple and robust prognostic factor in patients with multiple myeloma treated with high-dose therapy: long-term analysis of the IFM 99-02 and 99-04 Trials. J Clin Oncol. 2009 Dec 1;27(34):5720-6. doi: 10.1200/JCO.2008.21.1060. Epub 2009 Oct 13.
    pmid
    19826130
    type
    BACKGROUND
  5. citation
    Kyle RA, Rajkumar SV. Criteria for diagnosis, staging, risk stratification and response assessment of multiple myeloma. Leukemia. 2009 Jan;23(1):3-9. doi: 10.1038/leu.2008.291. Epub 2008 Oct 30.
    pmid
    18971951
    type
    BACKGROUND
  6. citation
    Alexanian R, Weber D, Giralt S, Dimopoulos M, Delasalle K, Smith T, Champlin R. Impact of complete remission with intensive therapy in patients with responsive multiple myeloma. Bone Marrow Transplant. 2001 May;27(10):1037-43. doi: 10.1038/sj.bmt.1703035.
    pmid
    11438818
    type
    BACKGROUND
  7. citation
    Alvares CL, Davies FE, Horton C, Patel G, Powles R, Sirohi B, Zuha R, Gatt A, Saso R, Treleaven JG, Dearden CE, Potter MN, Ethell ME, Morgan GJ. Long-term outcomes of previously untreated myeloma patients: responses to induction chemotherapy and high-dose melphalan incorporated within a risk stratification model can help to direct the use of novel treatments. Br J Haematol. 2005 Jun;129(5):607-14. doi: 10.1111/j.1365-2141.2005.05514.x.
    pmid
    15916682
    type
    BACKGROUND
  8. citation
    Bjorkstrand B, Goldstone AH, Ljungman P, Brandt L, Brunet S, Carlson K, Prentice G, Cavo M, Samson D, de Laurenzi A, et al. Prognostic factors in autologous stem cell transplantation for multiple myeloma: an EBMT Registry Study. European Group for Bone Marrow Transplantation. Leuk Lymphoma. 1994 Oct;15(3-4):265-72. doi: 10.3109/10428199409049723.
    pmid
    7866274
    type
    BACKGROUND
  9. citation
    Krejci M, Buchler T, Hajek R, Svobodnik A, Krivanova A, Pour L, Adam Z, Mayer J, Vorlicek J. Prognostic factors for survival after autologous transplantation: a single centre experience in 133 multiple myeloma patients. Bone Marrow Transplant. 2005 Jan;35(2):159-64. doi: 10.1038/sj.bmt.1704728.
    pmid
    15543200
    type
    BACKGROUND
  10. citation
    O'Shea D, Giles C, Terpos E, Perz J, Politou M, Sana V, Naresh K, Lampert I, Samson D, Narat S, Kanfer E, Olavarria E, Apperley JF, Rahemtulla A. Predictive factors for survival in myeloma patients who undergo autologous stem cell transplantation: a single-centre experience in 211 patients. Bone Marrow Transplant. 2006 Apr;37(8):731-7. doi: 10.1038/sj.bmt.1705307.
    pmid
    16501593
    type
    BACKGROUND
  11. citation
    Giralt S, Vesole DH, Somlo G, Krishnan A, Stadtmauer E, Mccarthy P, Pasquini MC; Blood and Marrow Transplant Clinical Trials Network Multiple Myeloma Working Group. Re: Tandem vs single autologous hematopoietic cell transplantation for the treatment of multiple myeloma: a systematic review and meta-analysis. J Natl Cancer Inst. 2009 Jul 1;101(13):964; author reply 966-7. doi: 10.1093/jnci/djp126. Epub 2009 Jun 17. No abstract available.
    pmid
    19535777
    type
    BACKGROUND
  12. citation
    Harousseau JL, Moreau P. Evolving role of stem cell transplantation in multiple myeloma. Clin Lymphoma Myeloma. 2005 Sep;6(2):89-95. doi: 10.3816/CLM.2005.n.034.
    pmid
    16231846
    type
    BACKGROUND
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-3d7416e2f85095a9e660
      requested nct id
      NCT02416206
      primary nct id
      NCT02416206
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      f69aaa3908585702eaa82e81f9dad53deed3a32820dc0863ac3142627863a7d0
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-3d7416e2f85095a9e660
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT02416206
      occurrences
      1. context exact
        NCT02416206
        end
        11
        exact text
        NCT02416206
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/802/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      dd68dc1dcb19278a05925ae9899702c1b44ac8d4e3d90536b1bfa8d59dee449d

    Preserved source evidence · Not medical advice