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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01582295
Recruitment Status : Completed
First Posted : April 20, 2012
Last Update Posted : May 25, 2017
Information provided by (Responsible Party):
Andrew Yee, MD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Cabozantinib Phase 1

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  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 2012
Primary Completion Date : August 2014
Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment Arm
Cabozantinib ( XL 184)
Drug: Cabozantinib
Starting dose 40 mg daily
Other Name: XL 184

Primary Outcome Measures :
  1. Safety of Cabozantinib [ Time Frame: 2 years ]
    To determine the safety of cabozantinib in patients with multiple myeloma with bone disease

Secondary Outcome Measures :
  1. 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. 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

  3. Objective Response per IMWG [ Time Frame: 2 years ]
    Objective response according to the International Myeloma Working Group Uniform Response Criteria (IMWG)

  4. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01582295

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Andrew Yee, MD Massachusetts General Hospital, Boston

Responsible Party: Andrew Yee, MD, Principal Investigator, Massachusetts General Hospital Identifier: NCT01582295     History of Changes
Other Study ID Numbers: 12-005
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017

Keywords provided by Andrew Yee, MD, Massachusetts General Hospital:
Bone disease

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Bone Diseases
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Musculoskeletal Diseases