Blood and Lymph Conditions

All Conditions

Neoplasms

Immune System Diseases

Rare Diseases

Thrombocytopenia

Lymphoma

Hodgkin Disease

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Blood Platelet Disorders

Hematologic Diseases

Cytopenia

Lymphosarcoma

Hodgkin Lymphoma

Planned Cohorts:

1. 100 mcg,
2. 300 mcg,
3. 700 mcg,
4. 1000 mcg;

   Optional Cohorts:
5. cohort expansion,
6. schedule change,
7. new dose

AMG 531

The purpose of this study is to identify a well-tolerated, effective dose and schedule of AMG 531 for the treatment of Chemotherapy Induced Thrombocytopenia (CIT) in subjects with lymphoma receiving multi-cycle chemotherapy.

A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma

An Open Label Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 for Treatment of Severe Thrombocytopenia Due to Multi-Cycle Chemotherapy in Adult Subjects With Lymphoma.

Change in platelet nadir from the previous qualifying cycle to the first treatment cycle.

Percentage of subjects experiencing grade 3 and/or 4 thrombocytopenia (\<50 x 10\^9/L, and \<25 x 10\^9/L)

Duration of grade 3 and/or 4 thrombocytopenia (\<50 x 10\^9/L and \<25 x 10\^9/L, respectively)

Percentage of subjects that received platelet transfusions during the first romiplostim treatment cycle

Amgen

Global Development Leader

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Romiplostim 100 µg

Romiplostim 300 µg

Romiplostim 700 µg

Romiplostim 1000 µg

Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy

Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy

Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy

Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy

Total

Age Continuous

Sex: Female, Male

White or Caucasian

Black or African American

Hispanic or Latino

Race/Ethnicity, Customized

Study Director

Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.

Change in Platelet Nadir

Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia

Duration of Grade 3 or 4 Thrombocytopenia

Percentage of Subjects That Received Platelet Transfusions

Overall Study

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Carboplatin

Doxorubicin

Liposomal doxorubicin

Ifosfamide

Isophosphamide mustard

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.

Chemotherapy :

1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. Adriamycin - Ifosfamide (AI) regimen \[Adriamycin 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2.

Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.

Chemotherapy :

1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. AI regimen \[Adriamycin 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2.

Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.

Chemotherapy :

1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. AI regimen \[Adriamycin 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2.

Cycle 1, Chemotherapy (Control Cycle); Beginning Cycle 2, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy (post dose) of 21-28 day treatment cycle.

Chemotherapy :

1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. AI regimen \[Adriamycin 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2.

Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses) of 21-28 day treatment cycle.

Chemotherapy :

1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. AI regimen \[Adriamycin 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2.

10 mcg/kg AMG 531 + Pre/Pre/Post/Post Chemotherapy Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses) of 21-28 day treatment cycle.

Chemotherapy :

1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. AI regimen \[Adriamycin 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2.

Beginning with Cycle 2, administered in one of two schedules, either on day after chemotherapy and 2 days later (study cycle) or on day -5 (pre dose) and on day after chemotherapy (post dose) or combination of pre/post days of 21-28 day treatment cycle. Combination if Optimal biological dose (OBD) not reached, additional treatment at 10 mcg/kg dose level, with AMG 531 administered on day -5 (pre dose) and on day after chemotherapy (post dose).

1, 3, or 10 mcg/kg given as injection under the skin (subcutaneous)

AUC=11; Cycle 1 chemotherapy alone then 3 weeks later, in Cycle 2, same dose of chemotherapy followed by AMG 531.

Adriamycin

10 gm/m\^2 IV; OR, High dose ifosfamide = 14 gm/m\^2.

Saroj Vadhan-Raj, MD

The goal of this clinical research study is to find the highest safe dose of AMG 531 that will decrease the risk and severity of thrombocytopenia (low platelet counts) in patients who have received chemotherapy. Researchers will also look at the safety and effectiveness of AMG 531 (Romiplostim).

Primary Objectives:

1. To determine the clinical safety and tolerability of AMG 531 administered following chemotherapy in patients with advanced malignancy
2. To determine an optimal biologic dose (OBD) of AMG 531 administered in patients receiving chemotherapy known to cause severe thrombocytopenia
3. To evaluate the effects of AMG 531 on the degree and duration of thrombocytopenia and platelet recovery following chemotherapy

Secondary Objective:

1. To evaluate limited pharmacokinetics of AMG 531 administered by S.C. route post-chemotherapy

Platelets are cells that help make the blood clot. A decrease in platelets can cause bleeding, which may prevent or delay a patient from receiving chemotherapy. Researchers want to find out if AMG 531 can lower the risk and severity of this side effect. AMG 531 is a protein that stimulates platelet production.

If you are eligible to take part in this study, you will be assigned to 1 of 6 dosing schedules of study drug. The dose of AMG 531 that you receive will depend on when you are enrolled.

In Cycle 1, all patients will receive chemotherapy by itself. Three (3) weeks later, in Cycle 2, the same dose of chemotherapy will be given followed by AMG 531. AMG 531 will be given on one of 3 schedules. AMG 531 will be given as an injection under the skin on the day after chemotherapy and 2 days later; it will be given 5 days before and the day after chemotherapy; or it will be given 5 and 3 days before chemotherapy and on the day after chemotherapy and 2 days later. The schedule you receive will depend on when you enroll on the study. After 2 cycles of treatment, based on response of the disease and tolerance to the treatment, all participants may be able to receive up to 4 more cycles of chemotherapy followed by AMG 531. All participants will continue on the same schedule you were receiving before. The dose of AMG 531 may be increased at one time point during the study based on the response of the platelet counts.

The number of blood tests drawn (about 3 teaspoons each) will depend on your clinical condition. These samples will be taken at least 2 times a week and as often as once a day during portions of the study. You will also have blood (about 1 teaspoon) collected for the evaluation of anti-AMG 531 antibody status before treatment starts, at the end of Cycles 2 and 4, and at the end of study.

You will be taken off the study if your disease gets worse or intolerable side effects occur. At the end of the study, you will have a medical history and physical exam, including measurement of vital signs. You will also have blood (about 1 teaspoon) drawn for routine tests.

This is an investigational study. AMG 531 is not FDA approved or commercially available. At this time, it is being used for research purposes only. Up to 56 patients will take part in this study. All will be enrolled at University of Texas (UT)MD Anderson.

AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin

Phase I/II Study of AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin

Number of participants experiencing an adverse event (AE) or serious adverse event (SAE) during study treatment, possible or probable related to study drug. All toxicities graded using the Common Terminology Criteria for Adverse Events version 3.0. Participation has a maximum of 6 cycles of chemotherapy on the study.

Number of participants experiencing an venous thromboembolism (VTE) related serious adverse event (SAE) during study treatment, possible or probable related to study drug. All toxicities graded using the Common Terminology Criteria for Adverse Events version 3.0. Participation has a maximum of 6 cycles of chemotherapy on the study. VTE events reported are part or whole total number reported for study SAEs, not in addition to SAEs reported.

M.D. Anderson Cancer Center

Cycle 1: Chemotherapy

Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later

1 mcg/kg AMG 531 Post Chemotherapy

Cycle 1: Chemotherapy

Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later

3 mcg/kg AMG 531 Post Chemotherapy

Cycle 1: Chemotherapy

Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later

10 mcg/kg AMG 531 Post Chemotherapy

Cycle 1: Chemotherapy

Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy

10 mcg/kg Pre/Post Chemotherapy

Cycle 1: Chemotherapy

Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)

5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy

Cycle 1: Chemotherapy

Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)

10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy

Age, Continuous

United States

Region of Enrollment

Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by AMG 531 subcutaneously of 21-28 day treatment cycle. There were 51 participants who received at least one dose of the study drug.

Dr. Saroj Vadhan-Raj

Adverse Events, Possible or Probable

Serious Adverse Events, Possible or Probable

Total Adverse Events

All participants who received treatment were evaluable for toxicity; therefore 51 participants who received at least one dose of the study drug were evaluable for toxicity.

Number of Participants With Adverse Events in Sequential Cohort Dose Escalation Study of AMG 531 Following Chemotherapy

Pulmonary Embolism (PE)

Deep Vein Thrombosis (DVT)

Total VTE Related SAEs

Number of Participants With Venous Thromboembolism (VTE) Related Serious Adverse Events in Sequential Cohort Dose Escalation Study of AMG 531 Following Chemotherapy

Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.

Chemotherapy :

1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. Adriamycin /Ifosfamide (AI) regimens \[Adriamycin (Doxorubicin) 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2

Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses) of 21-28 day treatment cycle.

Chemotherapy :

1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. AI regimen \[Adriamycin 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2.

Symptoms and General Pathology

Syndrome

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Precancerous Conditions

Lenalidomide

750 μg AMG 531 weekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A)

Placebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part B)

Placebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A)

500 μg AMG 531 weekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A)

750 μg AMG 531 biweekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part B)

AMG 531 will be administered by subcutaneous injection at a dose of 500 or 750 μg.

Subjects in the control group will receive placebo via subcutaneous injection.

Placebo

This is a dose and schedule finding study of AMG 531 designed to assess the activity of AMG 531 to reduce the rate of clinically significant bleeding and blood transfusions in subjects with myelodysplastic syndrome (MDS) receiving lenalidomide. Subjects with MDS that are planned to receive at least four cycles of lenalidomide for treatment of their disease are appropriate to screen for this study.

All subjects meeting the eligibility criteria will receive lenalidomide 10 mg capsule by mouth daily every day of each 28-day cycle. Subjects will receive AMG 531 or placebo once a week by subcutaneous injection for 16 weeks.

A Safety and Efficacy Study to Evaluate AMG 531 Treatment in Subject With Myelodysplastic Syndrome Receiving Revlimid

A Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) Receiving Lenalidomide.

Occurrence of one or more clinically significant thrombocytopenic events, defined as either Common Terminology Criteria for Adverse Events (CTCAE) v. 3 grade 3 or 4 thrombocytopenia starting from week 3 of cycle 1 or receipt of platelet transfusions starting from week 1 of cycle 1 and continuing through the end of treatment visit.

Occurrence of lenalidomide dose reduction and delay due to thrombocytopenia

CR = decrease in bone marrow blast (≤5%) and improvement in peripheral blood counts (Hgb ≥ 11 g/dL, platelets ≥ 100x10\^9/L, neutrophils ≥ 1x10\^9/L, peripheral blasts=0%). PR = improvement in peripheral blood counts plus a decrease in bone marrow blasts ≥50% but not ≤5, or decrease in International Prognostic Scoring System score.

Occurrence of one or more platelet transfusions during the treatment period

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Two subjects who were randomized to Placebo arm received one dose of Romiplostim inadvertently and were summarized in Romiplostim 750 mcg and 500 mcg arm, respectively.

Romiplostim 500 µg

Romiplostim 750 µg

Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks

Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks

Romiplostim 500 μg

Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks

Romiplostim 750 μg

>1.0

Missing

IPSS scoring for risk of myelodysplastic syndrome: 0 = low, 0.5 - 1.0 = intermediate 1, 1.5 - 2.0 = intermediate 2, ≥ 2.5 = high

International Prognostic Scoring System (IPSS) Score

Full Analysis Set, composed of all randomized participants

Occurrence of a Clinically Significant Thrombocytopenic Event

Lenalidomide Dose Reduction and Delay Due to Thrombocytopenia

Achieving an Overall Response (Complete Response (CR) or Partial Response (PR)) Determined by the Investigator Based on Modified International Working Group 2006 Response Criteria Guidelines

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma	NCT00283439	Chemotherapy-In... Hodgkin's Lymph... Non-Hodgkin's L... Cancer Oncology Thrombocytopeni...	AMG 531	18 Years -	Amgen
AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin	NCT00147225	Solid Tumors Advanced Cancer	AMG 531 Carboplatin Adriamycin Ifosfamide	18 Years -	M.D. Anderson Cancer Center
AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin	NCT00147225	Solid Tumors Advanced Cancer	AMG 531 Carboplatin Adriamycin Ifosfamide	18 Years -	M.D. Anderson Cancer Center
AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin	NCT00147225	Solid Tumors Advanced Cancer	AMG 531 Carboplatin Adriamycin Ifosfamide	18 Years -	M.D. Anderson Cancer Center
A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma	NCT00283439	Chemotherapy-In... Hodgkin's Lymph... Non-Hodgkin's L... Cancer Oncology Thrombocytopeni...	AMG 531	18 Years -	Amgen
A Safety and Efficacy Study to Evaluate AMG 531 Treatment in Subject With Myelodysplastic Syndrome Receiving Revlimid	NCT00418665	Myelodysplastic... Thrombocytopeni...	AMG 531 Placebo	18 Years -	Amgen

Spots Global Cancer Trial Database for amg 531

Every month we try and update this database with for amg 531 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for amg 531

Every month we try and update this database with for amg 531 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for amg 531 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.