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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

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


This is a multicenter, open label, dose escalation, Phase I / II study in subjects with
relapsed and/or refractory MM. Up to 24 subjects to be enrolled in the Phase I to determine
the RP2D. Up to 77 additional evaluable subjects to be enrolled in Phase II for a maximum up
to 101 subjects treated in the study. Study centers in the USA and the UK will participate
in Phase I and II. Centers in the Philippines will be participating in Phase II only. The
planned enrollment period is 22 months and the planned study duration is 28 months.


Accepts Healthy Volunteers: No

Inclusion Criteria:



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.

Exclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objectives: To establish the safety, tolerability, and RP2D (Phase I); To assess the overall response rate in subjects with advanced Multiple Myeloma (Phase II).

Outcome Time Frame:

21 day cycle

Safety Issue:

Yes

Principal Investigator

Michael Kurman, MD

Investigator Role:

Study Director

Investigator Affiliation:

Kyowa Hakko Kirin Pharma, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

2478-INT-001

NCT ID:

NCT01063907

Start Date:

March 2010

Completion Date:

December 2013

Related Keywords:

  • Multiple Myeloma
  • Leukemia
  • Immunoproliferative Disorder
  • Neoplasma by Histologic Type
  • Immune System Diseases
  • Hematologic Diseases
  • Blood Protein Disorders
  • Paraproteinemias
  • Multiple Myeloma
  • Hematologic Disorders
  • Leukemia, Chronic, B-cell
  • Leukemia, B-cell
  • Leukemia, Chronic
  • Neoplasms, Plasma Cell
  • Monoclonal Gammopathy of unknown significance (MGUS)
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location
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