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Luspatercept

BMS Study Connect www.BMSStudyconnect.com

First line of the email MUST contain the NCT# and Site#

Vu Phan, Site 0051

Marin Xavier, Site 0048

Amer Zeidan, Site 0033

Adewale Fawole, Site 0055

Ivor Percent, Site 0056

Jesus Gonzalez Lugo, Site 0020

Wederson Claudino, Site 0025

Ahmad Mattour, Site 0011

Site 0059

Site 0058

Lewis Silverman, Site 0032

Uma Borate, Site 0006

Site 0061

Luke Fletcher, Site 0054

Anna Koget, Site 0036

Praveen Kumar Tumula, Site 0043

Elham Abbasi-Hafshejani, Site 0022

Bhavana Bhatnagar, Site 0031

Ravi Narra, Site 0003

Site 0016

Dries Deeren, Site 0008

Anna Jonasova, Site 0004

Jaroslav Cermak, Site 0023

Thomas Cluzeau, Site 0041

Jose Miguel Torregrosa-Diaz, Site 0001

sylvain thepot, Site 0026

Sophie Park, Site 0007

Lionel Ades, Site 0046

Gaelle FOSSARD, Site 0053

Emmanuel Gyan, Site 0044

Site 0013

Eyck von der Heyde, Site 0040

Site 0009

Site 0021

Site 0062

Maria Teresa Voso, Site 0050

Luca Malcovati, Site 0015

Site 0029

Andrea Patriarca, Site 0014

Daniela Cilloni, Site 0045

Valeria Santini, Site 0024

Site 0030

Krzysztof Madry, Site 0010

Sebastian Grosicki, Site 0034

Site 0049

Aleksandra Butrym, Site 0035

Adelba Torres Lopez, Site 0047

Site 0017

David Ferreiras, Site 0005

Site 0052

Francisca Hernandez Mohedo, Site 0039

VALLE GOMEZ GARCIA DE SORIA, Site 0038

Jose Luis Sastre Moral, Site 0027

Maria Diez Campelo, Site 0028

Maria del Mar Tormo, Site 0018

Site 0063

Bristol-Myers Squibb

The purpose of this study is to evaluate the efficacy and safety of Luspatercept when administered at the maximum approved dose in low-risk Myelodysplastic Syndrome participants who require red blood cell transfusions.

A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants

A Phase 3b, Open-label Study Evaluating the Efficacy and Safety of Luspatercept (BMS-986346/ACE-536) Initiated at Maximum Approved Dose in LR-MDS With IPSS-R Very Low-, Low-, or Intermediate-risk Who Require RBC Transfusions (MAXILUS)

Heart and Blood Diseases

Immune System Diseases

Behaviors and Mental Disorders

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Quality of Life

Antineoplastic Agents

Antirheumatic Agents

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Analgesics

Fibrinolytic Agents

Anticoagulants

Anti-Infective Agents

Bone Density Conservation Agents

Etoposide

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Dexamethasone

Chrysarobin

Vincristine

Melphalan

Heparin

Cisplatin

Dexamethasone acetate

Etoposide phosphate

Thalidomide

Calcium heparin

Heparin, Low-Molecular-Weight

Tinzaparin

Dalteparin

Epoetin Alfa

Calcium

Calcium, Dietary

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Tubulin Modulators

Antimitotic Agents

Angiogenesis Inhibitors

Growth Inhibitors

Study participants were computer randomized to an individualized exercise program. Participants were stratified within Arm according to whether or not they received thalidomide with heparin, and by age (60 and younger versus older than 60)

Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified within Arm according to whether or not they received thalidomide with heparin, and by age (60 and younger versus older than 60)

Epoetin alfa was administered per an IRB approved algorithm to study participants when hemoglobin levels dropped during high dose chemotherapy. The usual dose is 150 units/kg og body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl.

A home-based individualized exercise program that incorporated aerobic and strength resistance training.

Exercise

Autologous Peripheral Blood Stem Cell Transplantation

RBC Transfusion was administered as needed

Red Blood Cell Transfusion

Fifty percent of the participants received 400 mg daily

Patients who received thalidomide also received prophylactic low molecular weight heparin

Platelet transfusions were administered as needed

Platelet Transfusion

Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma

Epoetin alfa was administered per an IRB approved algorithm to study participants when hemoglobin levels dropped during high dose chemotherapy. The usual dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl

Standard Induction chemotherapy care included: vincristine, doxorubicin, and dexamethasone (VAD) (0.5 mg, 10 mg/m2, and 40 mg, respectively);dexamethasone, cyclophosphamide,etoposide, and cisplatin (DCEP) (40 mg, 400 mg/m2, 40 mg/m2, and 15 mg/m2,respectively); and cyclophosphamide,doxorubicin, and dexamethasone (CAD) (750 mg/m2, 15 mg/m2, and 40 mg, respectively) for mobilization.

Total Therapy II

Fifty percent of participants received 400 mg daily

Sharon K Coon

The purpose of the study was to determine the effect of Epoetin alfa therapy (short term versus long term) with and without a home-based individualized exercise program that incorporated aerobic and strength resistance training for patients being treated with high-dose chemotherapy and autologous peripheral bloodstem cell transplantation (PBSC T) for multiple myeloma. The endpoints for the study included the number of attempts at and total number of days of stem cell collection, number of RBC and platelet transfusions during the transplantation period, time-to-recovery after transplantation, and response to intensive therapy for multiple myeloma.

Effects of Exercise in Combination With Epoetin Alfa

Effects of Exercise in Combination With Epoetin Alfa During High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma

The targeted hemoglobin level for each participant was 10-12 g/dl. This is the number of red blood cell (RBC) transfusions administered to participants, as part of the investigational therapy algorithm, in an attempt to alleviate the anemia caused by multiple myeloma and high-dose chemotherapy. The numbers of RBC and platelet transfusions were obtained from the University of Arkansas for Medical Sciences blood bank.

Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), During PBSCT and at hospital discharge.

Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), during PBSCT and at hospital discharge.

National Institutes of Health (NIH)

Ortho Biotech Clinical Affairs, L.L.C.

University of Arkansas

Elizabeth Ann Coleman, PhD, RNP, AOCN

All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.

Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (\<=60 versus \>60).Participants who received thalidomide also received low-molecular weight heparin

Usual Care

Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (\<=60 versus \>60). Participants who received thalidomide also received low-molecular weight heparin.

Total

Short Term Participants

Long Term Participants

Age, Continuous

Male (short term study)

Female (short term study)

Male (long term study)

Female (long term study)

Sex/Gender, Customized

Caucasian (short term study)

Other (short term study)

Caucasian (long term study)

Other (long term study)

Race/Ethnicity, Customized

United States

Region of Enrollment

Patients with hemoglobin \<8 g/dl received RBC transfusions according to the transplantation protocol. Analysis may have missed specific disease-related influences on hemoglobin. Randomization should have distributed disease risks equally for groups.

Elizabeth Ann Coleman

The null hypothesis was that there would be no difference between groups for the number of RBC transfusions.

For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).

Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)

The null hypothesis is that there was no difference in the number of RBC tranfusions in the exercise versus usual care groups. Data was combined from the short and long term RBC transfusions.

Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)

Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)

The null hypothesis was that there would be no difference between groups for the number of platelet transfusions.

Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)

Number of Stem Cell Collection Attempts (Short Term)

The null hypothesis was that there would be no difference between groups for the number of stem cell collection attempts.

Number of Stem Cell Collection Attempts (Long Term)

The null hypothesis was that there would be no difference between groups for the number of days of stem cell collections.

Total Number of Days of Stem Cell Collection (Short Term)

Total Number of Days of Stem Cell Collection (Long Term)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants	NCT06045689	Myelodysplastic...	Luspatercept	18 Years -	Bristol-Myers Squibb
Effects of Exercise in Combination With Epoetin Alfa	NCT00577096	Multiple Myelom...	Epoetin Alfa Exercise Autologous Peri... Red Blood Cell ... Thalidomide Heparin, Low-Mo... Platelet Transf... Melphalan Epoetin Alfa Total Therapy I... Red Blood Cell ... Thalidomide Heparin, Low-Mo... Platelet Transf... Melphalan	-	University of Arkansas
A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants	NCT06045689	Myelodysplastic...	Luspatercept	18 Years -	Bristol-Myers Squibb
Red Cell Transfusion Goals in Patients With Acute Leukemias	NCT02086773	Acute Lymphobla... Acute Lymphocyt... Acute Myelogeno... Acute Promyeloc...	Red blood cell ...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Real-World Practice Patterns and Outcomes of Lower-Risk Myelodysplastic Syndrome Patients in Japan	NCT06298643	Lower-risk Myel...	Red blood cell ... Red blood cell ...	18 Years -	Bristol-Myers Squibb
Study of Red Blood Cell Transfusion Triggers in Patients Undergoing Hematopoietic Stem Cell Transplantation	NCT01237639	Hematologic Mal...	Red blood cell ...	18 Years -	Ottawa Hospital Research Institute
Red Cell Transfusion Goals in Patients With Acute Leukemias	NCT02086773	Acute Lymphobla... Acute Lymphocyt... Acute Myelogeno... Acute Promyeloc...	Red blood cell ...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Effects of Exercise in Combination With Epoetin Alfa	NCT00577096	Multiple Myelom...	Epoetin Alfa Exercise Autologous Peri... Red Blood Cell ... Thalidomide Heparin, Low-Mo... Platelet Transf... Melphalan Epoetin Alfa Total Therapy I... Red Blood Cell ... Thalidomide Heparin, Low-Mo... Platelet Transf... Melphalan	-	University of Arkansas
Real-World Practice Patterns and Outcomes of Lower-Risk Myelodysplastic Syndrome Patients in Japan	NCT06298643	Lower-risk Myel...	Red blood cell ... Red blood cell ...	18 Years -	Bristol-Myers Squibb

Spots Global Cancer Trial Database for red blood cell transfusion