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

NCT01058434 | Completed Phase 2

• 2 other identifiers: CTKI258A22042009-012417-22
• Study Type: interventional
• Target: 43
• Locations: 7 countries
• Sites: 30

Brief Summary

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

Conditions

Relapsed or Refractory Multiple Myeloma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  4 weeks

Secondary Outcomes (3)

• 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

Study Arms (1)

TKI258

EXPERIMENTAL

Drug: TKI258

Interventions

TKI258 DRUG

TKI258

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Serum M-protein ≥ 1g/dL (measurable disease)
• Urine M-protein ≥ 200mg/24 hours by protein electrophoresis (measurable disease)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (30)

University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.

Mobile, Alabama, 36688, United States

Location

Central Hematology Oncology Medical Group

Alhambra, California, 91801, United States

Location

Central Coast Medical Oncology Corporation

Santa Maria, California, 93454, United States

Location

St. Jude Heritage Medical Group Virginia Crosson Cancer Center

Yorba Linda, California, 92886, United States

Location

Kootenai Medical Center Kootenai Medical Center

Coeur d'Alene, Idaho, 83814, United States

Location

Hematology and Oncology Specialists Dept of Hem&Onc Specialist - 2

Metairie, Louisiana, 70006, United States

Location

Mayo Clinic - Rochester Rochester

Rochester, Minnesota, 55905, United States

Location

Memorial Sloan Kettering Cancer Center MSKCC

New York, New York, 10021, United States

Location

Duke University Medical Center Dept. of DUMC (4)

Durham, North Carolina, 27710, United States

Location

Lancaster Cancer Center

Lancaster, Pennsylvania, 17601, United States

Location

Cancer Centers of the Carolinas Dept. of CC of the Carolinas

Greenville, South Carolina, 29605, United States

Location

University of Tennessee Cancer Institute SC-2

Memphis, Tennessee, 38104, United States

Location

University of Texas Southwestern Medical Center UTSW Medical Center

Dallas, Texas, 75390-8527, United States

Location

University of Wisconsin SC

Madison, Wisconsin, 53792, United States

Location

Medical College of Wisconsin Med College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Novartis Investigative Site

Adelaide, South Australia, 5000, Australia

Location

Novartis Investigative Site

Melbourne, Victoria, 3002, Australia

Location

Novartis Investigative Site

Prahran, Victoria, 3181, Australia

Location

Novartis Investigative Site

Toronto, Ontario, M5G 2M9, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H3A 1A1, Canada

Location

Novartis Investigative Site

Nantes, 44093, France

Location

Novartis Investigative Site

Bochum, 44892, Germany

Location

Novartis Investigative Site

Cologne, 50924, Germany

Location

Novartis Investigative Site

Heidelberg, 69120, Germany

Location

Novartis Investigative Site

Amsterdam, 1081 HV, Netherlands

Location

Novartis Investigative Site

Rotterdam, 3015 CE, Netherlands

Location

Novartis Investigative Site

Rotterdam, 3075 EA, Netherlands

Location

Novartis Investigative Site

Altunizade, 34662, Turkey (Türkiye)

Location

Novartis Investigative Site

Ankara, 06100, Turkey (Türkiye)

Location

Novartis Investigative Site

Izmir, 35040, Turkey (Türkiye)

Location

Related Publications (1)

• Scheid C, Reece D, Beksac M, Spencer A, Callander N, Sonneveld P, Kalimi G, Cai C, Shi M, Scott JW, Stewart AK. Phase 2 study of dovitinib in patients with relapsed or refractory multiple myeloma with or without t(4;14) translocation. Eur J Haematol. 2015 Oct;95(4):316-24. doi: 10.1111/ejh.12491. Epub 2015 Jan 22.

  PMID: 25402977 RESULT

Related Links

• CTKI258A2204 Results at Novartis Clinical Trials Results Website

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Interventions

4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: January 28, 2010
• Study Start: May 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: December 19, 2020

Record last verified: 2020-08

Locations

US (15); AU (3); FR (1); DE (3); CA (2); NL (3); TU (3)