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

• ClinicalTrials.gov Identifier: NCT01676961
• Recruitment Status: Terminated
• First Posted: August 31, 2012
• Results First Posted: September 5, 2017
• Last Update Posted: October 15, 2018
• Sponsor: NYU Langone Health
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): NYU Langone Health

Study Description

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

Condition or disease	Intervention/treatment	Phase
Refractory Multiple Myeloma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma; Thrombocytopenia	Biological: romiplostim	Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine if Nplate (romiplostim) is capable of increasing platelet counts to > 50 x 10^9/L for greater than 2 weeks in myeloma patients with chemotherapy induced thrombocytopenia.

SECONDARY OBJECTIVES:

I. To evaluate the toxicity of romiplostim in this patient population by standard Common Toxicity Criteria (CTC).

II. To determine any increase in thrombosis or marrow fibrosis.

OUTLINE:

Patients receive romiplostim subcutaneously (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.

After completion of study treatment, patients are followed up every 3 months for 1 year.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Phase II Trial Evaluating the Efficacy and Safety of Romiplostim (Nplate) Treatment of Chemotherapy Induced Thrombocytopenia in Patients With Multiple Myeloma
• Study Start Date: January 2013
• Actual Primary Completion Date: November 2015
• Actual Study Completion Date: November 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Supportive care (romiplostim); 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; Given SC; Other Names: AMG 531; Amgen megakaryopoiesis protein 2; Nplate

Outcome Measures

Primary Outcome Measures :

1. Percentage of Patients Who Have Responded [ Time Frame: 8 weeks ]
   Response is defined as platelet increases to greater than 50 x 10^9/L for more than 2 weeks.

Secondary Outcome Measures :

1. Percentage of Patients Who Experienced Thrombosis or Marrow Fibrosis [ Time Frame: Up to 1.5 years ]

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• 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

    1. Plasmacytomas on tissue biopsy
    2. Bone marrow plasmacytosis (> 30% plasma cells)
    3. 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

    1. Bone marrow plasmacytosis (10 to 30% plasma cells)
    2. Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
    3. Lytic bone lesions
    4. 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
    • Major criterion 1 plus minor criterion b, c, or d
    • Major criterion 3 plus minor criterion a or c
    • Minor criteria a, b and c or a, b and d
• Karnofsky performance status >= 50
• Platelet count =< 50 x 10^9/L untransfused of at least 2 weeks duration, secondary to prior chemotherapy. If there is a platelet count of > or = 50 x 10(9)/L after a transfusion, that value will be discounted.

This may include a combination regimen including lenalidomide; these regimens will include dexamethasone, cyclophosphamide, etoposide, cisplatin (DCEP), Velcade with Doxil, Cytoxan and/or lenalidomide; patients who have thrombocytopenia (CIT) from lenalidomide or from radiation therapy alone will not be allowed

• Calculated or measured creatinine clearance >= 30 mL/min

Exclusion Criteria:

• 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

Contacts and Locations

Locations

United States, New York

NYU Cancer Institute

New York, New York, United States, 10016

Sponsors and Collaborators

NYU Langone Health

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Amitabha Mazumder; NYU Langone Health

More Information

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT01676961
• Other Study ID Numbers: 10-02429; P30CA016087 ( U.S. NIH Grant/Contract )
• First Posted: August 31, 2012
• Results First Posted: September 5, 2017
• Last Update Posted: October 15, 2018
• Last Verified: September 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Thrombocytopenia; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Blood Platelet Disorders