CompletedPhase 2

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

United States43 participantsStarted 2010-05

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Cytopathologically or histologically confirmed diagnosis of multiple myeloma previously requiring systemic treatment.
✓. 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)
✓. 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.
✓. Presence of measurable disease as defined by at least one of the following;

✕. Patients with non-secretory, or oligosecretory, multiple myeloma.
✕. Patients with symptomatic amyloidosis, or with plasma cell leukemia.
✕. Patients who have received allogeneic stem cell transplantation and who show evidence of active graft-versus-host disease that requires immunosuppressive therapy.

Overall response rate

Timeframe: 4 weeks

NCT IDNCT01058434

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-02

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Cytopathologically or histologically confirmed diagnosis of multiple myeloma previously requiring systemic treatment.
✓. 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)
✓. 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.
✓. Presence of measurable disease as defined by at least one of the following;

✕. Patients with non-secretory, or oligosecretory, multiple myeloma.
✕. Patients with symptomatic amyloidosis, or with plasma cell leukemia.
✕. Patients who have received allogeneic stem cell transplantation and who show evidence of active graft-versus-host disease that requires immunosuppressive therapy.