XL184 For Relapsed/Refractory Multiple Myeloma (MM) With Bone Disease

May 23, 2017 updated by: Andrew Yee, MD, Massachusetts General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
Cabozantinib ( XL 184)
Drug: Cabozantinib
Starting dose 40 mg daily
Other Names:
  • XL 184

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of Cabozantinib
Time Frame: 2 years
To determine the safety of cabozantinib in patients with multiple myeloma with bone disease
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Biochemical Markers
Time Frame: 2 years
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
2 years
Effect of Cabozantinib on Bone Disease
Time Frame: 2 years
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
2 years
Objective Response per IMWG
Time Frame: 2 years
Objective response according to the International Myeloma Working Group Uniform Response Criteria (IMWG)
2 years
Pain Assessment
Time Frame: 2 years
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Andrew Yee, MD, Massachusetts General Hospital, Boston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

April 19, 2012

First Submitted That Met QC Criteria

April 19, 2012

First Posted (Estimate)

April 20, 2012

Study Record Updates

Last Update Posted (Actual)

May 25, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on Cabozantinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe