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NCT00916058 · REGISTRY CONDITION SEARCH

Conditioning Regimen of Bendamustine and Melphalan Followed by Transplant in Patients With 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
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2019-06-04

The purpose of this study is to evaluate the safety and efficacy of Bendamustine (TREANDA™), in combination with Melphalan in subjects with multiple myeloma who are undergoing an Autologous Stem Cell Transplant.

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

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baseline

Baseline characteristics

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outcome · POSTED

Maximum Tolerated Dose (Phase 1)

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outcome · POSTED

Overall Response Rate (Phase 2) - Number of Participants Achieving at Least a Partial Response or Better in Disease Status at Day 100 Post-transplant

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outcome · POSTED

Progression-Free Survival (Phase 1)

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outcome · POSTED

Progression-Free Survival (Phase 2)

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outcome · POSTED

Overall Survival at 2 Years (Phase 1)

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outcome · POSTED

Overall Survival at 3 Years (Phase 2)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Patients with multiple myeloma who have received induction therapy and have had stem cells mobilized in preparation for autologous transplantation will be eligible for this study. Patients are also eligible with relapsed or refractory disease, after attempts at more standard approaches, and with the availability of stem cells. * Patients must be age 18 or older. * Patients must have a life expectancy of at least 12 weeks. * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. * Patients must provide written informed consent. Exclusion Criteria: * Impaired renal function with a measured or calculated creatinine clearance of less than 25 ml/min. * Impaired hepatic function defined as a bilirubin greater than 1.5 x upper limit of normal (ULN) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 5 x ULN. * Serious active or uncontrolled infection or medical condition. * Women who are pregnant or breast feeding. Women of childbearing age must use adequate contraception and have a negative pregnancy test. * Impaired pulmonary function with a diffusing capacity of the lung for carbon monoxide (DLCO) less than 45% predicted. * Impaired cardiac function with an ejection fraction less than 40% of predicted. * Other systemic anticancer therapy or ongoing toxicities from such therapy.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Dose Level 1; Bendamustine 30 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
    intervention Names
    1. Drug: Bendamustine
    2. Drug: Melphalan
    label
    Dose Level 1
    type
    EXPERIMENTAL
  2. description
    Dose Level 2; Bendamustine 60 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
    intervention Names
    1. Drug: Melphalan
    2. Drug: Bendamustine
    label
    Dose Level 2
    type
    EXPERIMENTAL
  3. description
    Dose Level 3; Bendamustine 90 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
    intervention Names
    1. Drug: Melphalan
    2. Drug: Bendamustine
    label
    Dose Level 3
    type
    EXPERIMENTAL
  4. description
    Dose Level 4; Bendamustine 120 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
    intervention Names
    1. Drug: Melphalan
    2. Drug: Bendamustine
    label
    Dose Level 4
    type
    EXPERIMENTAL
  5. description
    Dose Level 5; Bendamustine 150 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
    intervention Names
    1. Drug: Melphalan
    2. Drug: Bendamustine
    label
    Dose Level 5
    type
    EXPERIMENTAL
  6. description
    Dose Level 6; Bendamustine 225 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
    intervention Names
    1. Drug: Melphalan
    2. Drug: Bendamustine
    label
    Dose Level 6
    type
    EXPERIMENTAL
  7. description
    Bendamustine 225 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
    intervention Names
    1. Drug: Melphalan
    2. Drug: Bendamustine
    label
    Phase 2
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Dose Level 1
    description
    30 mg/m\^2 given on day 2 of melphalan
    name
    Bendamustine
    other Names
    1. Treanda
    type
    DRUG
  2. arm Group Labels
    1. Dose Level 1
    2. Dose Level 2
    3. Dose Level 3
    4. Dose Level 4
    5. Dose Level 5
    6. Dose Level 6
    7. Phase 2
    description
    100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
    name
    Melphalan
    other Names
    1. Alkeran
    type
    DRUG
  3. arm Group Labels
    1. Dose Level 2
    description
    60 mg/m\^2 given on the 2nd day of melphalan
    name
    Bendamustine
    other Names
    1. Treanda
    type
    DRUG
  4. arm Group Labels
    1. Dose Level 3
    description
    90 mg/m\^2 given on the 2nd day of melphalan
    name
    Bendamustine
    other Names
    1. Treanda
    type
    DRUG
  5. arm Group Labels
    1. Dose Level 4
    description
    60 mg/m\^2 given on the 1st and 2nd day of melphalan
    name
    Bendamustine
    other Names
    1. Treanda
    type
    DRUG
  6. arm Group Labels
    1. Dose Level 5
    description
    90 mg/m\^2 given on the 1st day of melphalan and 60 mg/m\^2 given on the 2nd day of melphalan
    name
    Bendamustine
    other Names
    1. Treanda
    type
    DRUG
  7. arm Group Labels
    1. Dose Level 6
    2. Phase 2
    description
    125 mg/m\^2 given on the 1st day of melphalan and 100mg/m\^2 given on the 2nd day of melphalan
    name
    Bendamustine
    other Names
    1. Treanda
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SEQUENTIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
57
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The Maximum Tolerated Dose was not met in Phase 1 of the study. Phase 2 participants were enrolled at the highest dose administered in Phase 1 (Dose Level 6) and this Outcome Measure is the reported number of dose-limiting toxicities experienced by Phase 1 participants. DLTs were defined as any grade 3 non-hematologic adverse even that did not resolve within 72 hours, any occurrence of a grade 4 non-hematologic adverse event, or failure to engraft with an absolute neutrophil count of 500/mm\^3 and platelet count of 20,000/mm\^3 untransfused by Day 35 post-transplant.
    measure
    Maximum Tolerated Dose (Phase 1)
    time Frame
    35 days post-transplant
  2. description
    Number of patients achieving at least a partial response or better in disease status at Day 100 post-transplant, as defined by the International Myeloma Working Group (IMWG) disease response criteria. Partial response in disease status is defined by the IMWG as ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to \<200 mg per 24 hours; If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria; If serum and urine M-protein are unmeasurable, and serum-free light assay is also unmeasurable, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma-cell percentage was ≥30%. In addition to these criteria, if present at baseline, a ≥50% reduction in the size (SPD) of soft tissue plasmacytomas is also required
    measure
    Overall Response Rate (Phase 2) - Number of Participants Achieving at Least a Partial Response or Better in Disease Status at Day 100 Post-transplant
    time Frame
    100 days post-transplant
secondary Outcomes
  1. description
    Time elapsed between Day 0 and disease progression, as defined by the International Myeloma Working Group (IMWG) disease response criteria. Disease progression is defined as an increase of \>25% from lowest response value in any one or more of the following: * Serum M-component and/or (the absolute increase must be \> 0.5 g/dL) * Urine M-component and/or (the absolute increase must be \> 200 mg/24 h) * Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved free light chain levels. The absolute increase must be \> 10 mg/dL * Bone marrow plasma cell percentage; the absolute percentage must be \> 10% * Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas * Development of hypercalcaemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder
    measure
    Progression-Free Survival (Phase 1)
    time Frame
    From Day 0 to first incidence of disease progression, up to 1,128 days
  2. description
    Time elapsed between Day 0 and disease progression, as defined by the International Myeloma Working Group (IMWG) disease response criteria. Disease progression is defined as an increase of \>25% from lowest response value in any one or more of the following: * Serum M-component and/or (the absolute increase must be \> 0.5 g/dL) * Urine M-component and/or (the absolute increase must be \> 200 mg/24 h) * Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved free light chain levels. The absolute increase must be \> 10 mg/dL * Bone marrow plasma cell percentage; the absolute percentage must be \> 10% * Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas * Development of hypercalcaemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder
    measure
    Progression-Free Survival (Phase 2)
    time Frame
    From Day 0 to first incidence of disease progression, up to 86 months
  3. description
    Time elapsed between Day 0 and death from any cause, whichever came first, assessed up to 2 years.
    measure
    Overall Survival at 2 Years (Phase 1)
    time Frame
    From Day 0 until time of death, assessed up to 2 years.
  4. description
    Time elapsed between Day 0 and death from any cause, whichever came first, assessed up to 3 years.
    measure
    Overall Survival at 3 Years (Phase 2)
    time Frame
    From Day 0 until time of death, assessed up to 3 years.
Full study description
brief Summary
The purpose of this study is to evaluate the safety and efficacy of Bendamustine (TREANDA™), in combination with Melphalan in subjects with multiple myeloma who are undergoing an Autologous Stem Cell Transplant.
detailed Description
Bendamustine (TREANDA™) has been used in clinical trials to treat multiple myeloma. The results from these trials suggest that it may be beneficial in the treatment of multiple myeloma in a different treatment context. Researchers aim to determine if there may be an improved benefit in the context of bone marrow transplant. This initial clinical trial is intended to help determine how safe it is to use bendamustine as a conditioning regimen for bone marrow transplant, and to look for any initial evidence of benefit. Bendamustine (TREANDA™) is approved by the Food and Drug Administration (FDA) for the treatment of Chronic Lymphocytic Leukemia and Melphalan is a type of chemotherapy drug. The use of Melphalan alone as a conditioning regimen for Autologous Stem Cell Transplant is considered "Standard of Care," that is, the treatment or process that your doctor would normally follow to treat your disease. Although Bendamustine (TREANDA™) has been used in multiple myeloma research studies, the combination of Bendamustine (TREANDA™) and Melphalan as treatment for Multiple Myeloma is not approved by the FDA, thus the combination therapy used in this research study is considered "investigational."
Source references
references
  1. citation
    Gomez-Arteaga A, Mark TM, Guarneri D, Christos PJ, Gergis U, Greenberg JD, Hsu J, Mayer SA, Niesvizky R, Pearse RN, Phillips AA, Rossi A, Coleman M, van Besien K, Shore TB. High-dose bendamustine and melphalan conditioning for autologous stem cell transplantation for patients with multiple myeloma. Bone Marrow Transplant. 2019 Dec;54(12):2027-2038. doi: 10.1038/s41409-019-0587-0. Epub 2019 Jun 12.
    pmid
    31190006
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice