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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01058434




Registration number
NCT01058434
Ethics application status
Date submitted
26/01/2010
Date registered
28/01/2010
Date last updated
19/12/2020

Titles & IDs
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
Secondary ID [1] 0 0
2009-012417-22
Secondary ID [2] 0 0
CTKI258A2204
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed or Refractory Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TKI258

Experimental: TKI258 -


Treatment: Drugs: TKI258
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall response rate
Timepoint [1] 0 0
4 weeks
Secondary outcome [1] 0 0
frequency and severity of adverse events as per CTCAE
Timepoint [1] 0 0
throughout the study
Secondary outcome [2] 0 0
Progression free survival (PFS)
Timepoint [2] 0 0
every 4 weeks
Secondary outcome [3] 0 0
Plasma exposure of TKI258
Timepoint [3] 0 0
during the first 3 cycles

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2013
Sample size
Target
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [2] 0 0
Novartis Investigative Site - Melbourne
Recruitment hospital [3] 0 0
Novartis Investigative Site - Prahran
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3002 - Melbourne
Recruitment postcode(s) [3] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Idaho
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
France
State/province [15] 0 0
Nantes Cedex 1
Country [16] 0 0
Germany
State/province [16] 0 0
Bochum
Country [17] 0 0
Germany
State/province [17] 0 0
Heidelberg
Country [18] 0 0
Germany
State/province [18] 0 0
Köln
Country [19] 0 0
Netherlands
State/province [19] 0 0
Amsterdam
Country [20] 0 0
Netherlands
State/province [20] 0 0
Rotterdam
Country [21] 0 0
Turkey
State/province [21] 0 0
Altunizade
Country [22] 0 0
Turkey
State/province [22] 0 0
Ankara
Country [23] 0 0
Turkey
State/province [23] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate safety and efficacy of TKI258 in patients with relapsed or
refractory multiple myeloma
Trial website
https://clinicaltrials.gov/ct2/show/NCT01058434
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries