A Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma
Public ClinicalTrials.gov record NCT01063907. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open Label, Dose Escalation, Multicenter Phase 1/2 Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to assess the safety and benefits of the investigational study drug, KW-2478, when given with bortezomib (Velcade®), a drug approved for the treatment of Multiple Myeloma (MM). The primary objectives: * To establish the safety, tolerability, and recommended Phase II dose (RP2D) of KW-2478 in combination with bortezomib (Phase I); * To assess the overall response rate (ORR) when subjects with advanced MM are treated (Phase II). The secondary objectives: * To characterize the Pharmacokinetic (PK) and Pharmacodynamic (PD) of KW-2478 with bortezomib (Phase I only); * To evaluate for preliminary evidence of efficacy (Phase I); * To determine progression free survival (PFS) and duration of response of KW-2478 with bortezomib (Phase II).
Study identification
- NCT ID
- NCT01063907
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 95 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2010
- Primary completion
- Oct 31, 2013
- Completion
- Oct 31, 2013
- Last update posted
- Apr 24, 2024
2010 – 2013
United States locations
- U.S. sites
- 9
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Clinical Research Center, Inc. / Arizona Oncology Associates, 1825 N Kolb, | Tucson | Arizona | 85715 | — |
| Pacific Shores Medical Group 1043 Elm Ave, Suite 104 | Long Beach | California | 90813 | — |
| UCLA Medical Center Hematology / Oncology Division, 10945 Le Conte Ave #2333, | Los Angeles | California | 90095-7059 | — |
| Collaborative Research Group 2320 S Seacrest Blvd, Suite 202 | Boynton Beach | Florida | 33435 | — |
| Rush University Medical Center / Division of Hematology/Oncology Research 1725 W Harrison Street, Suite 834 | Chicago | Illinois | 60612 | — |
| Cancer Institute of New Jersey 195 Little Albany Street | New Brunswick | New Jersey | 08903-2681 | — |
| The Jones Clinic 7710 Wolf River Circle | Germantown | Tennessee | 38138 | — |
| UT MD Anderson Cancer Center, 1515 Holcombe Boulevard, | Houston | Texas | 77030 | — |
| Gundersen Clinic Center for Cancer and Blood Disorders, 1900 South Ave, EB2-001, | La Crosse | Wisconsin | 54601 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 17 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01063907, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 24, 2024 · Synced Sep 27, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01063907 live on ClinicalTrials.gov.