Phase 2
N=95
A Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT01063907 ↗Enrolled (actual)
95
Serious AEs
50.5%
Results posted
Nov 2014
Primary outcome: Primary: To Establish the Safety, Tolerability, and RP2D (Phase 1); To Assess the Overall Response Rate in Subjects With Advanced Multiple Myeloma (Phase 2). — 95; 3; 3; 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- KW-2478 (Drug); Bortezomib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kyowa Kirin Co., Ltd.
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Establish the Safety, Tolerability, and RP2D (Phase 1); To Assess the Overall Response Rate in Subjects With Advanced Multiple Myeloma (Phase 2). |
95; 3; 3; 3; 6; 80 | — |
| SECONDARY Phase 1: PK Absorption Tmax hr Day 11 |
1.03; 1.03; 1.11; 1.07 | — |
| SECONDARY Phase 1: PK Exposure Cmax ng/mL Day 11 |
7910; 41000; 5990; 5280 | — |
| SECONDARY Phase 1: PK Exposure AUC0-t hr*ng/mL Day 11 |
7940; 26200; 7190; 6040 | — |
| SECONDARY Phase 1: PK Elimination t½ hr Day 11 |
1.88; 2.02; 1.84; 1.77 | — |
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).
Eligibility Criteria
Accepts Healthy Volunteers: No
Inclusion Criteria
- 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.
- Signed either an IRB or IEC approved informed consent
- ECOG performance status of ≤ 2
- Life expectancy of at least 3 months
- 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
- Adequate hematologic status, liver and renal function
- Subjects of reproductive potential must agree to follow accepted pregnancy prevention methods during the study.
Exclusion Criteria
- No anti-cancer treatment for ≥ 4 weeks and no bortezomib treatment ≥ 60 days prior to receiving study drug
- Any other severe, acute or chronic illness
- No other prior or concurrent malignancy
- No immunosuppressant therapy
Data sourced from ClinicalTrials.gov (NCT01063907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.