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| ID | Type | Description | Link |
|---|---|---|---|
| GO27825 | Other Identifier | Hoffmann-La Roche |
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This multicenter, open-label, dose-escalating study will assess the safety and efficacy of DFRF4539A in patients with relapsed or refractory multiple myeloma. Cohorts of patients will receive multiple ascending doses of intravenous DFRF4539A every 3 weeks or weekly. Patients exhibiting acceptable safety and evidence of clinical benefit may receive DFRF4539A for up to 17 cycles. Anticipated time on study treatment is 1 year or until disease progression or unacceptable toxicity occurs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DFRF4539A | Drug | multiple ascending doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | approximately 3.5 years | |
| Safety: Maximum tolerated dose/dose-limiting toxicities | approximately 1.5 years | |
| Recommended Phase II dose for every-3-week or weekly administration of DFRF4539A | approximately 3.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity: Serum antitherapeutic antibody levels | approximately 3.5 years | |
| Pharmacokinetics: Area under the concentration - time curve (AUC) | approximately 3.5 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale | Arizona | 85259 | United States | |||
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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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| Objective response, tumor assessments according to International Myeloma Working Group (IMWG) Uniform Response Criteria and/or European Bone Marrow Transplant (EBMT) Criteria |
| approximately 3.5 years |
| Duration of objective response, defined as time from first documented objective response to progression or death of any cause | approximately 3.5 years |
| Progression-free survival, defined as time from first study treatment (Cycle 1, Day 1) to disease progression or death during study or within 30 days after last dose of study drug, whichever occurs first | approximately 3.5 years |
| Duarte |
| California |
| 91010 |
| United States |
| Jacksonville | Florida | 32224 | United States |
| Sarasota | Florida | 34232 | United States |
| Chicago | Illinois | 60611 | United States |
| Bethesda | Maryland | 20817 | United States |
| New York | New York | 10021 | United States |
| Nashville | Tennessee | 37203 | United States |
| 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 |