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No response seen in patients
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To determine the overall response rate (CR+PR) of patients with relapsed or refractory multiple myeloma treated with clofarabine.
To determine the time to response, duration of response, and time to progression of patients treated with clofarabine.
To determine the safety and tolerability of clofarabine in these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clofarabine | Experimental | 4 mg/m2 IV over 1 hour on days 1-5 of each 28 day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clofarabine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (CR+PR) | Every 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to response | Every 3 months | |
| Safety and tolerability of clofarabine | 30 days after last treatment | |
| Duration of response |
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Inclusion Criteria:
Multiple myeloma diagnosed by standard criteria.
Measurable levels of monoclonal protein in serum (>= 0.5 g/dL) or urine (>= 0.2 g/24 hr).
At least 1 prior therapies for multiple myeloma with documented evidence of progression on the most recent treatment.
Age 18 years or older.
ECOG performance status <= 2.
Acceptable organ and marrow function as defined below:
Women of child bearing potential must agree to use adequate contraception prior to study entry and for the duration of study.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ravi Vij, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D000077866 | Clofarabine |
| ID | Term |
|---|---|
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Every 3 months |
| Time to progression | Every 3 months |
| D014652 |
| Vascular Diseases |
| 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 |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D009711 | Nucleotides |
| D012265 | Ribonucleotides |