Multiple MyelomaPhase 1NCT01582295
XL184 For Relapsed/Refractory Multiple Myeloma (MM) With Bone Disease
A Phase 1 study testing Cabozantinib in people with Multiple Myeloma, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Cabozantinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2012to Nov 2014
- Phase
- Phase 1
- 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
- Relapsed/Refractory Multiple Myeloma
- Skeletal lesions suggestive of bone involvement
- Must have received at least 2 lines of prior systemic therapy for the treatment of multiple myeloma
- Must have received prior treatment with a proteasome inhibitor
- Agree to use medically accepted barrier method of contraception
- Not a candidate for ASCT, has declined the option or has relapsed after prior ASCT
Who cannot join
- Pregnant or breastfeeding
- Has received radiotherapy to thoracic cavity or GI tract (within 3 months of first dose of study drug), bone or brain metastasis (within 14 days of first dose) or any other site (within 28 days)
- Has received any other investigational agent within 28 days
- Primary brain tumor
- Uncontrolled, significant intercurrent or recent illness
- Cardiovascular disorder(s)
- Gastrointestinal disorder(s)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Dose Finding Pilot Study of Cabozantinib (XL184) Administered Orally as Monotherapy for the Treatment of Patients With Relapsed or Relapsed/Refractory Multiple Myeloma With Bone Disease
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. It also means the FDA has not approved the drug for your type of cancer.
Cabozantanib (XL184) is a new drug that is being developed to treat cancer. The study drug cabozantinib works by inhibiting several different proteins which are believed to be involved in multiple myeloma growth, its ability to spread, and its ability to form new blood vessels. This drug has been used in other research studies and information from those other research studies suggests that this drug may help to slow or stop disease growth to bones and prevent cancer growth.
In this research study, we are looking to see how effective cabozantanib is in slowing or stopping disease growth to the bones as well as preventing your cancer from worsening. We are also looking for the highest dose of cabozantinib that can be given safely to patients who have multiple myeloma with bone disease.
Read the detailed description
Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have multiple myeloma, not everyone who participates in this research study will receive the same dose of study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses.
The study drug, cabozantinib, comes in the form of tablets which you will take by mouth. You will take your dose of cabozantinib once a day during each 28 day cycle.
Detailed instructions on how to take the study drug and which foods and drinks you will be prohibited from taking during the research study can be found in your study drug diary.
During Cycle 1, you will come into the clinic weekly (Day 1, 8, 15 and 22). For all other cycles, you will come into the clinic on Day 1 and 15.
A visit will be scheduled 30 days after you have finished or stopped taking the study drug so your doctor will be able to check your well being.
- Conditions
- Multiple Myeloma
- Being tested
- Cabozantinib
- Keywords
- Bone disease
- Medical subject headings
- Multiple Myeloma, Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabozantinibDrug
Also called XL 184
Starting dose 40 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Cabozantinib ( XL 184) Receives: Drug: Cabozantinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Cabozantinib
To determine the safety of cabozantinib in patients with multiple myeloma with bone disease
Measured: 2 years
Secondary outcomes (4)
Changes in Biochemical Markers
Changes in biochemical markers of bone turnover, including serum bone specific alkaline phosphatase, osteocalcin, sclerostin, P1nP (procollagen type 1N propeptide) and urine N-telopeptide before treatment and end of cycle 2
Measured: 2 years
Effect of Cabozantinib on Bone Disease
To evaluate the effect of cabozantinib on bone disease as assessed by post-treatment changes on whole body FDG-PET/CT scan before treatment and end of cycle 2
Measured: 2 years
Objective Response per IMWG
Objective response according to the International Myeloma Working Group Uniform Response Criteria (IMWG)
Measured: 2 years
Pain Assessment
Pain will be assessed using the Pain Assessment Tool included in the appendix. The questionnaire will be administered at screening, day 1 of each cycle and end of treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Yee, MD, Massachusetts General Hospital
- Investigators
- Andrew Yee, MD, Principal investigator, Massachusetts General Hospital, Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582295
- Sponsor's protocol ID
- 12-005
- Status last verified
- May 2017
- First submitted
- 19 Apr 2012
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Finding Pilot Study of Cabozantinib (XL184) Administered Orally as Monotherapy for the Treatment of Patients With Relapsed or Relapsed/Refractory Multiple Myeloma With Bone Disease
- ClinicalTrials.gov ID
- NCT01582295
- Acronym / sponsor ID
- 12-005
- Conditions
- Multiple Myeloma
- Keywords
- Bone disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 20 Apr 2012 (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 research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. It also means the FDA has not approved the drug for your type of cancer.
Cabozantanib (XL184) is a new drug that is being developed to treat cancer. The study drug cabozantinib works by inhibiting several different proteins which are believed to be involved in multiple myeloma growth, its ability to spread, and its ability to form new blood vessels. This drug has been used in other research studies and information from those other research studies suggests that this drug may help to slow or stop disease growth to bones and prevent cancer growth.
In this research study, we are looking to see how effective cabozantanib is in slowing or stopping disease growth to the bones as well as preventing your cancer from worsening. We are also looking for the highest dose of cabozantinib that can be given safely to patients who have multiple myeloma with bone disease.
Detailed description
Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have multiple myeloma, not everyone who participates in this research study will receive the same dose of study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses.
The study drug, cabozantinib, comes in the form of tablets which you will take by mouth. You will take your dose of cabozantinib once a day during each 28 day cycle.
Detailed instructions on how to take the study drug and which foods and drinks you will be prohibited from taking during the research study can be found in your study drug diary.
During Cycle 1, you will come into the clinic weekly (Day 1, 8, 15 and 22). For all other cycles, you will come into the clinic on Day 1 and 15.
A visit will be scheduled 30 days after you have finished or stopped taking the study drug so your doctor will be able to check your well being.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: CabozantinibCabozantinib ( XL 184) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Relapsed/Refractory Multiple Myeloma
- Skeletal lesions suggestive of bone involvement
- Must have received at least 2 lines of prior systemic therapy for the treatment of multiple myeloma
- Must have received prior treatment with a proteasome inhibitor
- Agree to use medically accepted barrier method of contraception
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding
- Has received radiotherapy to thoracic cavity or GI tract (within 3 months of first dose of study drug), bone or brain metastasis (within 14 days of first dose) or any other site (within 28 days)
- Has received any other investigational agent within 28 days
- Primary brain tumor
- Uncontrolled, significant intercurrent or recent illness
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 |
|---|---|---|
| CabozantinibAlso: XL 184Starting dose 40 mg daily | Drug | Treatment Arm |
Primary outcome
Safety of Cabozantinib
Time frame: 2 years
To determine the safety of cabozantinib in patients with multiple myeloma with bone disease
4 secondary outcomes
Changes in Biochemical Markers
Time frame: 2 years
Effect of Cabozantinib on Bone Disease
Time frame: 2 years
Objective Response per IMWG
Time frame: 2 years
Pain Assessment
Time frame: 2 years
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 25 May 2017.
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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.
Andrew Yee, MD principal investigator
Massachusetts General Hospital, Boston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cabozantinib in people with Multiple Myeloma, run by Massachusetts General Hospital at 2 sites in United States.
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 7 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 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety of Cabozantinib (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2017.