Romiplostim in Increasing Low Platelet Counts in Patients With Multiple Myeloma Receiving Chemotherapy

NCT01676961 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 10-02429P30CA016087
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well romiplostim works in increasing low platelet counts in patients with multiple myeloma receiving chemotherapy. Romiplostim may cause the body to make platelets after chemotherapy

Conditions

Refractory Multiple Myeloma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma; Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Who Have Responded

  Response is defined as platelet increases to greater than 50 x 10\^9/L for more than 2 weeks.

  8 weeks

Secondary Outcomes (1)

• Percentage of Patients Who Experienced Thrombosis or Marrow Fibrosis

  Up to 1.5 years

Study Arms (1)

Supportive care (romiplostim)

EXPERIMENTAL

Patients receive romiplostim SC once weekly for up to 6 weeks. Patients achieving a platelet count \> 50 x 10\^9 then receive romiplostim once weekly during 1 course of chemotherapy and may continue for as long as benefit is seen..

Biological: romiplostim

Interventions

romiplostim BIOLOGICAL

Given SC

Also known as: AMG 531, Amgen megakaryopoiesis protein 2, Nplate

Supportive care (romiplostim)

Eligibility Criteria

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

You may qualify if:

• Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
• Subject is not pregnant or breast feeding, and cannot become pregnant within 30 days after the end of treatment
• Female subject of child bearing potential must be willing to use, in combination with her partner, 2 forms highly effective contraception during treatment and for 1 month after the end of treatment
• Diagnosis of any stage of multiple myeloma based on standard criteria as follows:
• Major criteria
• Plasmacytomas on tissue biopsy
• Bone marrow plasmacytosis (\> 30% plasma cells)
• Monoclonal immunoglobulin spike on serum electrophoresis (immunoglobin G \[IgG\] \> 3.5 G/dL or immunoglobin A \[IgA\] \> 2.0 G/dL) or kappa or lambda light chain excretion \> 1 G/day on 24 hour urine protein electrophoresis
• Minor criteria
• Bone marrow plasmacytosis (10 to 30% plasma cells)
• Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
• Lytic bone lesions
• Normal immunoglobin M (IgM) \< 50 mg/dL, IgA \< 100 mg/dL, or IgG \< 600 mg/dL
• Any of the following sets of criteria will confirm the diagnosis of multiple myeloma:
• Any two of the major criteria

You may not qualify if:

• POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein \[M-protein\] and skin changes)
• Plasma cell leukemia
• Receiving steroids daily for other medical conditions, e.g., asthma, systemic lupus erythematosus, rheumatoid arthritis
• Infection not controlled by antibiotics
• Human immunodeficiency virus (HIV) infection; patients should provide consent for HIV testing according to the institution's standard practice
• Known active hepatitis B or C
• Patient had myocardial infarction within 6 months prior to enrollment, New York Hospital Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; prior to study entry, any electrocardiogram (ECG) abnormality at screening must be documented by the investigator as not medically relevant
• Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
• Other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
• Female subject is pregnant or lactating; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test result obtained during screening; pregnancy testing is not required for postmenopausal or surgically sterilized women
• Patient has \> 1.5 x upper limit of normal (ULN) total bilirubin
• Patients with existing deep venous thrombosis will be excluded
• Patients receiving maintenance therapy with myelosuppressive medications such as lenalidomide will be excluded

Sponsors & Collaborators

• NYU Langone Health: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

NYU Cancer Institute

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Thrombocytopenia

Interventions

romiplostim

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Blood Platelet Disorders; Cytopenia

Results Point of Contact

• Title: Amitabha Mazumder, MD
• Organization: NYU Clinical Cancer Center

Amitabha.Mazumder@nyumc.org

(212) 731-5757

Study Officials

• Amitabha Mazumder

  NYU Langone Health

  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: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2012
• First Posted: August 31, 2012
• Study Start: January 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 15, 2018
• Results First Posted: September 5, 2017

Record last verified: 2018-09

Locations

US (1)