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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

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


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.


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of Cabozantinib

Outcome Description:

To determine the safety of cabozantinib in patients with multiple myeloma with bone disease

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Andrew Yee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital, Boston

Authority:

United States: Food and Drug Administration

Study ID:

12-005

NCT ID:

NCT01582295

Start Date:

June 2012

Completion Date:

December 2014

Related Keywords:

  • Multiple Myeloma
  • Bone disease
  • Bone Diseases
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617