Multiple Myeloma Clinical Trial
Official title:
A Phase 1-2 Study of a Novel Conditioning Regimen of Bendamustine and Melphalan Followed by Autologous Stem Cell Transplant for Patients With Multiple Myeloma
Verified date | May 2019 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 57 |
Est. completion date | March 1, 2018 |
Est. primary completion date | March 11, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Medical College | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Tolerated Dose (Phase 1) | 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. | 35 days post-transplant | |
Primary | Overall Response Rate (Phase 2) - Number of Participants Achieving at Least a Partial Response or Better in Disease Status at Day 100 Post-transplant | 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 | 100 days post-transplant | |
Secondary | Progression-Free Survival (Phase 1) | 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 |
From Day 0 to first incidence of disease progression, up to 1,128 days | |
Secondary | Progression-Free Survival (Phase 2) | 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 |
From Day 0 to first incidence of disease progression, up to 86 months | |
Secondary | Overall Survival at 2 Years (Phase 1) | Time elapsed between Day 0 and death from any cause, whichever came first, assessed up to 2 years. | From Day 0 until time of death, assessed up to 2 years. | |
Secondary | Overall Survival at 3 Years (Phase 2) | Time elapsed between Day 0 and death from any cause, whichever came first, assessed up to 3 years. | From Day 0 until time of death, assessed up to 3 years. |
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