Relapsed or Refractory Multiple MyelomaPhase 2NCT01058434
Safety and Efficacy of TKI258 in Relapsed or Refractory Multiple Myeloma Patients, Who Are With or Without t(4;14) Chromosomal Translocation
A Phase 2 study testing TKI258 in people with Relapsed or Refractory Multiple Myeloma, run by Novartis Pharmaceuticals at 30 sites in 7 countries.
Trial summary
This study will evaluate safety and efficacy of TKI258 in patients with relapsed or refractory multiple myeloma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma
- What is being tested?
- TKI258
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 30 sitesin 7 countries
- Study dates
- May 2010to Feb 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
30 sites in 7 countries.
30 sites in 7 countries
United States15 sites
Central Hematology Oncology Medical Group
Alhambra, California, 91801
Kootenai Medical Center Kootenai Medical Center
Coeur d'Alene, Idaho, 83814
University of Texas Southwestern Medical Center UTSW Medical Center
Dallas, Texas, 75390-8527
Duke University Medical Center Dept. of DUMC (4)
Durham, North Carolina, 27710
Cancer Centers of the Carolinas Dept. of CC of the Carolinas
Greenville, South Carolina, 29605
Lancaster Cancer Center
Lancaster, Pennsylvania, 17601
University of Wisconsin SC
Madison, Wisconsin, 53792
University of Tennessee Cancer Institute SC-2
Memphis, Tennessee, 38104
Hematology and Oncology Specialists Dept of Hem&Onc Specialist - 2
Metairie, Louisiana, 70006
Medical College of Wisconsin Med College of Wisconsin
Milwaukee, Wisconsin, 53226
University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.
Mobile, Alabama, 36688
Memorial Sloan Kettering Cancer Center MSKCC
New York, New York, 10021
Mayo Clinic - Rochester Rochester
Rochester, Minnesota, 55905
Central Coast Medical Oncology Corporation
Santa Maria, California, 93454
St. Jude Heritage Medical Group Virginia Crosson Cancer Center
Yorba Linda, California, 92886
Australia3 sites
Novartis Investigative Site
Adelaide, South Australia, 5000
Novartis Investigative Site
Melbourne, Victoria, 3002
Novartis Investigative Site
Prahran, Victoria, 3181
Germany3 sites
Novartis Investigative Site
Bochum, 44892
Novartis Investigative Site
Cologne, 50924
Novartis Investigative Site
Heidelberg, 69120
Netherlands3 sites
Novartis Investigative Site
Amsterdam, 1081 HV
Novartis Investigative Site
Rotterdam, 3015 CE
Novartis Investigative Site
Rotterdam, 3075 EA
Turkey (Türkiye)3 sites
Novartis Investigative Site
Altunizade, 34662
Novartis Investigative Site
Ankara, 06100
Novartis Investigative Site
Izmir, 35040
Canada2 sites
Novartis Investigative Site
Montreal, Quebec, H3A 1A1
Novartis Investigative Site
Toronto, Ontario, M5G 2M9
About this study
Official 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
This study will evaluate safety and efficacy of TKI258 in patients with relapsed or refractory multiple myeloma
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Being tested
- TKI258
- Keywords
- Multiple myeloma, relapsed, refractory, t(4;14), FGFR3
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TKI258Drug
| Study group | Role | What they receive |
|---|---|---|
| TKI258 | Experimental | Not described Receives: Drug: TKI258 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: 4 weeks
Secondary outcomes (3)
frequency and severity of adverse events as per CTCAE
Measured: throughout the study
Progression free survival (PFS)
Measured: every 4 weeks
Plasma exposure of TKI258
Measured: during the first 3 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058434
- Sponsor's protocol ID
- CTKI258A2204
- Other IDs
- 2009-012417-22, 2009
- Status last verified
- Aug 2020
- First submitted
- 26 Jan 2010
- Last updated
- 19 Dec 2020
- Results posted
- No
Publications
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.
PubMed 25402977
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01058434
- Acronym / sponsor ID
- CTKI258A2204
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Keywords
- Multiple myeloma, relapsed, refractory, t(4;14), FGFR3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 28 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate safety and efficacy of TKI258 in patients with relapsed or refractory multiple myeloma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TKI258 | Experimental | Drug: TKI258 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
- Other protocol-defined inclusion/exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TKI258 | Drug | TKI258 |
Primary outcome
Overall response rate
Time frame: 4 weeks
3 secondary outcomes
frequency and severity of adverse events as per CTCAE
Time frame: throughout the study
Progression free survival (PFS)
Time frame: every 4 weeks
Plasma exposure of TKI258
Time frame: during the first 3 cycles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Results publication: PubMed 25402977Scheid 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.
- CTKI258A2204 Results at Novartis Clinical Trials Results WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
30 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TKI258 in people with Relapsed or Refractory Multiple Myeloma, run by Novartis Pharmaceuticals at 30 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Australia, Germany, Netherlands, Turkey (Türkiye) and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01058434, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.