NCT01582295

Brief 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. "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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1 multiple-myeloma

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_1 multiple-myeloma

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

May 25, 2017

Status Verified

May 1, 2017

Enrollment Period

2.2 years

First QC Date

April 19, 2012

Last Update Submit

May 23, 2017

Conditions

Multiple Myeloma

Keywords

Bone disease

Outcome Measures

Primary Outcomes (1)

  • Safety of Cabozantinib

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

    2 years

Secondary Outcomes (4)

  • Changes in Biochemical Markers

    2 years

  • Effect of Cabozantinib on Bone Disease

    2 years

  • Objective Response per IMWG

    2 years

  • Pain Assessment

    2 years

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Cabozantinib ( XL 184)

Drug: Cabozantinib

Interventions

CabozantinibDRUG

Starting dose 40 mg daily

Also known as: XL 184
Treatment Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Multiple MyelomaBone Diseases

Interventions

cabozantinib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesMusculoskeletal Diseases

Study Officials

  • Andrew Yee, MD

    Massachusetts General Hospital, Boston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 19, 2012

First Posted

April 20, 2012

Study Start

June 1, 2012

Primary Completion

August 1, 2014

Study Completion

November 1, 2014

Last Updated

May 25, 2017

Record last verified: 2017-05

Locations

US(2)