A Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma

Study summary

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).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedKW-2478 and Bortezomib

The study team can explain what participation involves.

Who it may be forRecurrent or relapsed · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 25, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?26 U.S. locations

Locations may change over time.

Who runs it?Kyowa Kirin Co., Ltd.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: Kyowa Kirin Co., Ltd.
Interventions being studied: Drug: KW-2478; Drug: Bortezomib

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting

Recurrent or relapsed→Resistant or refractory→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Accepts Healthy Volunteers: No 1. Subjects with a confirmed diagnosis of Multiple Myeloma who have had one and no more than three prior regimens for MM to which they did not respond (failed) or from which they have relapsed. 2. Signed either an IRB or IEC approved informed consent 3. ECOG performance status of ≤ 2 4. Life expectancy of at least 3 months 5. M protein in either serum or urine, or free light chains if not measurable M protein in serum or urine, and clonal bone marrow plasma cells \> 10%, and evidence of end organ damage 6. Adequate hematologic status, liver and renal function 7. Subjects of reproductive potential must agree to follow accepted pregnancy prevention methods during the study.

Reasons someone may not be able to joinExclusion criteria

1. No anti-cancer treatment for ≥ 4 weeks and no bortezomib treatment ≥ 60 days prior to receiving study drug 2. Any other severe, acute or chronic illness 3. No other prior or concurrent malignancy 4. No immunosuppressant therapy

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Arizona Clinical Research Center, Inc. / Arizona Oncology Associates, 1825 N Kolb,Tucson, Arizona
Pacific Shores Medical Group 1043 Elm Ave, Suite 104Long Beach, California
UCLA Medical Center Hematology / Oncology Division, 10945 Le Conte Ave #2333,Los Angeles, California
Collaborative Research Group 2320 S Seacrest Blvd, Suite 202Boynton Beach, Florida
Rush University Medical Center / Division of Hematology/Oncology Research 1725 W Harrison Street, Suite 834Chicago, Illinois
Cancer Institute of New Jersey 195 Little Albany StreetNew Brunswick, New Jersey
The Jones Clinic 7710 Wolf River CircleGermantown, Tennessee
UT MD Anderson Cancer Center, 1515 Holcombe Boulevard,Houston, Texas
Gundersen Clinic Center for Cancer and Blood Disorders, 1900 South Ave, EB2-001,La Crosse, Wisconsin
The Medical City, 1609 MATI Building, The Medical City, Ortigas Avenue,Pasig, Manila
National Kidney and Transplant Institute, Rm 3215 Doctors Clinic, East AvenueDiliman, Quezon City
Makati Medical Center, New Wing Hall C372, #2 Amorsolo Street, Legaspi Village,Makati City

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 25, 2024. Always confirm current availability with the study team.

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