Eltrombopag for Thrombocytopenia in Patients With Relapsed Multiple Myeloma

NCT01484314 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 11-373
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Eltrombopag is a compound that may help stimulate the production of platelets. This drug has been used in treatment of low platelet counts caused by a disorder called idiopathic thrombocytopenic purpura and information from those other research studies suggests that Eltrombopag may help to maintain platelet counts in patients with relapsed multiple myeloma in this research study. In this research study,the investigators are trying to determine if Eltrombopag is effective in maintaining platelet counts in patients who are being treated for relapsed multiple myeloma.

Conditions

Thrombocytopenia; Multiple Myeloma

Keywords

Relapsed

Outcome Measures

Primary Outcomes (2)

• Maintenance of Platelet Count

  To determine the proportion of patients with relapsed multiple myeloma in whom eltrombopag maintains platelet counts at \> 90% of baseline platelet counts with no more than 4 units of platelet transfusions at day 1 of Cycle 3 of chemotherapy

  2 years

• Safety and Tolerability

  To determine whether eltrombopag administration results in an increased number of participants with adverse events.

  2 years

Secondary Outcomes (1)

• Incidence of Grade 3/4 Thrombocytopenic Events

  2 years

Study Arms (1)

Migration Arm

EXPERIMENTAL

Administration of eltrombopag to support platelets during chemotherapy

Drug: Eltrombopag

Interventions

Eltrombopag DRUG

100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy

Migration Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have histologically confirmed multiple myeloma that is relapsed or refractory
• Patients may have had 1 or more prior chemotherapy regimens for multiple myeloma but none within the preceding 14 days
• Performance status (ECOG) ≤ 2
• Not pregnant or breastfeeding

You may not qualify if:

• Participants with a history of rapidly progressive disease \[increase in tumor size (≥ 50%) as defined by standard myeloma markers \], pelvic irradiation, chemotherapy or radiotherapy within the preceding 14 days
• Participants may not be receiving any other study agents within 21 days prior to entry on the study.
• The use of growth factors other than erythropoiesis stimulating agents or G-CSF (Neupogen or Neulasta) during the study period.
• Participants with evidence of active thromboembolic disease or a history of thromboembolism within the preceding 6 months (excluding thrombosis of a central line).
• Participants with a documented history of genetic predisposition for thrombosis (anti-phospholipid antibody syndrome, AT-III deficiency, etc.), platelet disorder or bleeding disorder.
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Individuals with a history of other malignancies are eligible only if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the preceding 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Thrombocytopenia; Multiple Myeloma; Recurrence

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study is limited because it terminated early with only 1 patient enrolled.

Results Point of Contact

• Title: Dr. Nancy Berliner
• Organization: Brigham and Womens Hospital/ Dana Farber Cancer Institute

nberliner@parnes.org

617-732-5840

Study Officials

• Nancy Berliner, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: November 30, 2011
• First Posted: December 2, 2011
• Study Start: April 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2015
• Last Updated: March 15, 2017
• Results First Posted: November 17, 2016

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)