Safety and Efficacy of TKI258 in Relapsed or Refractory Multiple Myeloma Patients, Who Are With or Without t(4;14) Chromosomal Translocation

A Phase II, Multi-center, Non-randomized, Open-label Study of TKI258 in Patients With Relapsed or Refractory Multiple Myeloma, Who Are With or Without t(4;14) Translocation

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01058434

Enrollment

Registered

2010-01-28

Start date

2010-05-31

Completion date

2013-02-28

Last updated

2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed or Refractory Multiple Myeloma

Keywords

Multiple myeloma, relapsed, refractory, t(4;14), FGFR3

Brief summary

This study will evaluate safety and efficacy of TKI258 in patients with relapsed or refractory multiple myeloma

Interventions

DRUGTKI258

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Cytopathologically or histologically confirmed diagnosis of multiple myeloma previously requiring systemic treatment. 2. Evidence of relapsed or refractory disease as documented from the prior treatment history. (Refractory myeloma is defined as disease that is non-responsive while on salvage therapy, or progresses within 60 days of last therapy. Relapsed myeloma is defined as previously treated myeloma which after a period of being off-therapy requires the initiation of salvage therapy. Detailed definitions provided in the PTS-1) 3. Have received at least 2 prior treatment regimens for multiple myeloma including chemotherapy, autologous transplantation, immunotherapy, or other investigational agents. Pre-planned induction, followed by transplant and maintenance should be considered as one regimen. 4. Presence of measurable disease as defined by at least one of the following; * Serum M-protein ≥ 1g/dL (measurable disease) * Urine M-protein ≥ 200mg/24 hours by protein electrophoresis (measurable disease)

Exclusion criteria

1. Patients with non-secretory, or oligosecretory, multiple myeloma. 2. Patients with symptomatic amyloidosis, or with plasma cell leukemia. 3. Patients who have received allogeneic stem cell transplantation and who show evidence of active graft-versus-host disease that requires immunosuppressive therapy. Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Overall response rate	4 weeks

Secondary

Measure	Time frame
frequency and severity of adverse events as per CTCAE	throughout the study
Progression free survival (PFS)	every 4 weeks
Plasma exposure of TKI258	during the first 3 cycles

Countries

Australia, Canada, France, Germany, Netherlands, Turkey (Türkiye), United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026