Multiple Myeloma Clinical Trial
Official title:
Autologous Transplantation for Multiple Myeloma
Verified date | November 2021 |
Source | Masonic Cancer Center, University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a study of a regimen of melphalan and autologous stem cells for patients with multiple myeloma. We hypothesize that this particular regimen will improve the survival of these patients.
Status | Completed |
Enrollment | 363 |
Est. completion date | August 1, 2020 |
Est. primary completion date | August 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Patients meeting the Durie and Salmon criteria for initial diagnosis of multiple myeloma, requiring therapy and meeting one of the following: - After initial therapy in either first complete or partial remission or no objective response - After achieving initial response and later disease progression, patient will be eligible after subsequent therapy upon achievement of either complete or partial response - Is not eligible or has refused any protocols of higher priority - 18 - 75 years of age - Adequate organ function defined as: - Hematologic: hemoglobin = 8 gm/dl (untransfused), white blood cells (WBC) = 3000/µl, absolute neutrophil count (ANC) = 1500/µl, platelets = 100,000/µl (untransfused) - Cardiac: no active ischemia, left ventricular ejection fraction > 45% by MUGA scan - Hepatic: bilirubin < 2.0 mg/dl, ALT < 3x the upper limit of normal - Pulmonary: FEV1-Forced Expiratory Volume in One Second AND Forced vital capacity (FVC) >50% predicted and Carbon Monoxide Diffusing Capacity (DLCO) (corrected) > 50% predicted - Performance status: Karnofsky performance of > 80%. - Free of active uncontrolled infection at the time of study entry. - At time of study enrollment > 4 weeks from prior myelosuppressive chemotherapy; and > 6 weeks from prior nitrosoureas. - Patients must exercise informed voluntary consent and sign a consent form approved by the University of Minnesota IRB: Human Subjects Committee. Exclusion Criteria: - Patients will be ineligible if they have advanced myeloma refractory and unresponsive to salvage chemotherapy regimens. - Female patients who are pregnant (positive b-HCG) or breastfeeding will be excluded from study entry. In addition fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment, particularly after thalidomide will also be excluded from study entry. |
Country | Name | City | State |
---|---|---|---|
United States | Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Masonic Cancer Center, University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Achieving a Complete Response | Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR: Normal free light chain ratio Absence of clonal cells in bone marrow Complete Response (CR): Absence of the original monoclonal paraprotein <5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy No increase in size or number of lytic bone lesions Disappearance of soft tissue plasmacytomas. |
100 Days post transplant | |
Primary | Number of Participants Achieving a Complete Response | Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR: Normal free light chain ratio Absence of clonal cells in bone marrow Complete Response (CR): Absence of the original monoclonal paraprotein <5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy No increase in size or number of lytic bone lesions Disappearance of soft tissue plasmacytomas. |
6 months post transplant | |
Primary | Number of Participants Achieving a Complete Response | Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR: Normal free light chain ratio Absence of clonal cells in bone marrow Complete Response (CR): Absence of the original monoclonal paraprotein <5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy No increase in size or number of lytic bone lesions Disappearance of soft tissue plasmacytomas. |
12 months post transplant | |
Secondary | Number of Patients With Extended Disease-free Survival | Extended disease free survival will be defined as percentage of patients surviving more than 36 months without relapse or disease progression. | 36 Months | |
Secondary | Number of Participants With Overall Survival | The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. | 1 year | |
Secondary | Number of Participants With Overall Survival | The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. | 2 years | |
Secondary | Number of Participants With Overall Survival | The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. | 3 years | |
Secondary | Count of Participants Experiencing Transplant Related Mortality | In the field of transplantation, toxicity is high and all deaths without previous relapse or progression are usually considered as related to transplantation. | 1 year | |
Secondary | Number of Participants Experiencing Incidence of Relapse | The return of disease after its apparent recovery/cessation. | 1 year | |
Secondary | Number of Participants With Disease Progression | Myeloma Response Definitions - Using International Uniform Response Criteria: Progressive Disease (PD) For patients not in CR or sCR, progressive disease requires one or more of the following: >25% increase in the level of the serum monoclonal paraprotein, which must also be an absolute increase of at least 0.5 g/dL. >25% increase in 24-hour urine protein electrophoresis, which must also be an absolute increase of at least 200 mg/24 hours. Absolute increase in the difference between involved and uninvolved FLC levels (absolute increase must be >10 mg/dl), only in patients without measurable paraprotein in the serum and urine. >25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%. Definite increase in the size of existing bone lesions or soft tissue plasmacytomas. |
1 year | |
Secondary | Time to Progression | Mean number of days among patients progressing | 1 year | |
Secondary | Time to Relapse | Mean number of days among patients relapsing | 1 year | |
Secondary | Number of Participants With Absolute Neutrophil Recovery | Hematologic recovery is defined by absolute neutrophil count (ANC) >2500/µl and platelets > 100,000/µl | Day 42 | |
Secondary | Time to Attainment of CR | Mean (STD) among patients achieving complete remission (CR) Myeloma Response Definitions - Using International Uniform Response Criteria: Complete Response (CR): Absence of the original monoclonal paraprotein <5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy No increase in size or number of lytic bone lesions Disappearance of soft tissue plasmacytomas |
12 months post transplant | |
Secondary | Time to Attainment of CR+PR | Mean (STD) among patients achieving complete remission (CR) and partial remission (PR) Myeloma Response Definitions - Using International Uniform Response Criteria: Complete Response (CR): Absence of the original monoclonal paraprotein <5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy No increase in size or number of lytic bone lesions Disappearance of soft tissue plasmacytomas. Partial Response (PR): Greater than or equal to 50% reduction in the level of the serum monoclonal paraprotein and/or reduction in 24 hour urinary monoclonal paraprotein either by greater than or equal to 90% or to <200 mg/24 hours in light chain disease. If the only measurable non-bone marrow parameter is FLC, greater than or equal to 50% reduction in the difference between involved and uninvolved FLC levels or a 50% decrease in level |
12 months post transplant | |
Secondary | Duration of Maintenance Treatment | During study | ||
Secondary | Dropout Rate From Maintenance Therapy | Post transplant phase | ||
Secondary | Number of Participants With Toxicities | Occurrence of toxicities by first 100 days of transplant | By first 100 days | |
Secondary | Number of Participants With Infections | Occurrence of infections in the patients by the first 100 days of transplant | By first 100 days |
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