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TKI258 in Subjects With Refractory or Relapsed Multiple Myeloma

Phase 1 Dose Escalating Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TKI258 in Subjects With Refractory or Relapsed Multiple Myeloma

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00243763
Enrollment
64
Registered
2005-10-25
Start date
Unknown
Completion date
Unknown
Last updated
2009-11-23

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

Conditions

Multiple Myeloma

Keywords

Refractory Multiple Myeloma or, Relapsed Multiple Myeloma

Brief summary

The primary objective of this study is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), and safety profile of CHIR-258 when administered to subjects with refractory or relapsed multiple myeloma (MM).

Interventions

DRUGTKI258

Sponsors

Novartis
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Confirmed diagnosis of multiple myeloma * Evidence of relapsed or refractory disease

Exclusion criteria

* Intracranial disease or epidural disease * Clinically significant cardiac disease * Diabetes mellitus

Design outcomes

Primary

MeasureTime frame
Maximum tolerated dose
Dose limiting toxicity
Safety profile

Secondary

MeasureTime frame
Evaluation of pharmacokinetics and pharmacodynamics

Countries

United States

Outcome results

None listed

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