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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA015083 | U.S. NIH Grant/Contract | View source | |
| MC0687 | Other Identifier | Mayo Clinic Cancer Center | |
| 06-005792 | Other Identifier | Mayo Clinic IRB |
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Due to competing trials, this study is permanenlty closed to patient acrrual.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Biological therapies, such as anti-thymocyte globulin, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Anti-thymocyte globulin may also make cancer cells more sensitive to melphalan. Giving anti-thymocyte globulin together with melphalan may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving anti-thymocyte globulin together with melphalan works in treating patients with relapsed multiple myeloma.
OBJECTIVES:
Primary
* To evaluate the hematological response rate of anti-thymocyte globulin given in combination with melphalan in patients with relapsed multiple myeloma.
Secondary
After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-thymocyte Globulin/Melphalan | Experimental | Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-thymocyte globulin | Biological | 2.5 mg/kg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hematological Response Rate Defined as the Number of Participants Who Achieve a Confirmed Response | Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment. Complete Response(CR): Disappearance of M-protein from serum and urine, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow. Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100mg per 24hours. Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200mg per 24hours; or >=50% decrease in difference between involved and uninvolved FLC levels. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from registration to death of any cause. | up to 2 years |
| Progression-free Survival (PFS) | PFS was defined as the time from registration to progression or death due to any cause. Progression was defined as any one or more of the following: An increase of 25% from lowest confirmed response in:
|
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DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma
- Relapsed disease
Must not be a candidate for stem cell transplantation, has refused transplantation, or has had stem cells collected previously
Measurable disease, defined by ≥ 1 of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No limit to prior therapy
At least 4 weeks since prior melphalan or other myelosuppressive agents
At least 2 weeks since prior non-myelosuppressive agents (e.g., thalidomide or high-dose corticosteroids)
No concurrent high-dose corticosteroids
Concurrent bisphosphonates allowed
No concurrent immunosuppressive medications such as cyclosporine
No other concurrent investigational treatment
No concurrent cytotoxic chemotherapy or external-beam radiotherapy>
No other concurrent systemic anti-neoplastic therapy including, but not limited to, immunotherapy, hormonal therapy, or monoclonal antibody therapy
No concurrent prophylactic hematopoietic growth factors (unless for treatment of an established cytopenia)
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| Name | Affiliation | Role |
|---|---|---|
| Shaji K. Kumar, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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One (1) patient was recruited from May 2008 to September 2008 at Mayo Clinic. This trial was permanently closed in March 2009 due to competing trials.
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| ID | Title | Description |
|---|---|---|
| FG000 | Anti-thymocyte Globulin/Melphalan | Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Anti-thymocyte Globulin/Melphalan | Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hematological Response Rate Defined as the Number of Participants Who Achieve a Confirmed Response | Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment. Complete Response(CR): Disappearance of M-protein from serum and urine, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow. Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100mg per 24hours. Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200mg per 24hours; or >=50% decrease in difference between involved and uninvolved FLC levels. | One participant was evaluable for the primary endpoint. | Posted | Number | participants | 4 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anti-thymocyte Globulin/Melphalan | Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
After 1 patient was recruited, this trial temporarily closed to allow the first dose of Anti-thymocyte Globulin to be split over two days. Before the modification was written, it was decided to permanently close this study due to competing trials.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shaji Kumar | Mayo Clinic | kumar.shaji@mayo.edu |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000961 | Antilymphocyte Serum |
| D008558 | Melphalan |
| ID | Term |
|---|---|
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| melphalan |
| Drug |
16 mg/m^2 |
|
| up to 2 years |
| Duration of Response (DOR) | DOR was calculated from the documentation of response (CR, VGPR or PR) until the date of progression in the subset of patients who responded. | up to 2 years |
| Number of Participants With Severe Non-hematological Adverse Events | Severe non-hematologic adverse events were defined as adverse events grade 3 or higher, regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0) | every month during treatment, up to 12 months |
| Participants |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Prior Stem Cell Transplant | Number | participants |
|
| Parameters of Hematologic Response | Serum M-Spike >=1 g/dL | Number | participants |
|
| Parameters of Hematologic Response | Serum immunoglobulin free light chain >= 10 mg/dL | Number | participants |
|
| Parameters of Hematologic Response | Urine M-Spike >= 200 mg/24 hours | Number | participants |
|
| Parameters of Hematologic Response | Bone marrow plasma cells > 30% | Number | participants |
|
|
|
| Secondary | Overall Survival (OS) | OS was defined as the time from registration to death of any cause. | Posted | Median | 95% Confidence Interval | months | up to 2 years |
|
|
|
| Secondary | Progression-free Survival (PFS) | PFS was defined as the time from registration to progression or death due to any cause. Progression was defined as any one or more of the following: An increase of 25% from lowest confirmed response in:
| Posted | Median | 95% Confidence Interval | months | up to 2 years |
|
|
|
| Secondary | Duration of Response (DOR) | DOR was calculated from the documentation of response (CR, VGPR or PR) until the date of progression in the subset of patients who responded. | All patients are non-evaluable - no patients responded to treatment. | Posted | up to 2 years |
|
|
| Secondary | Number of Participants With Severe Non-hematological Adverse Events | Severe non-hematologic adverse events were defined as adverse events grade 3 or higher, regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0) | Posted | Number | participants | every month during treatment, up to 12 months |
|
|
|
| 0 |
| 1 |
| 1 |
| 1 |
| Hypersensitivity | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Opportunistic Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Leukopenia | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Neutrophil Count Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Platelet Count Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
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| D002318 |
| Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |