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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01058434
• Date of registration: 26/01/2010
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Safety and Efficacy of TKI258 in Relapsed or Refractory Multiple Myeloma Patients, Who Are With or Without t(4;14) Chromosomal Translocation
• Scientific title: 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
• Date of first enrolment: May 2010
• Target sample size: 43
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01058434
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Australia, Canada, France, Germany, Netherlands, Spain, Turkey, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

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/exclusion criteria may apply



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Relapsed or Refractory Multiple Myeloma

Intervention(s)

Drug: TKI258

Primary Outcome(s)

Overall response rate [Time Frame: 4 weeks]

Secondary Outcome(s)

Plasma exposure of TKI258 [Time Frame: during the first 3 cycles]

Progression free survival (PFS) [Time Frame: every 4 weeks]

frequency and severity of adverse events as per CTCAE [Time Frame: throughout the study]

Secondary ID(s)

2009-012417-22

CTKI258A2204

Source(s) of Monetary Support

Please refer to primary and secondary sponsors