A 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