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A Study to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 Alone or in Combination With G-CSF in Patients With Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 Alone or in Combination With G-CSF in Patients With Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease

NCT01458288•GPCR Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This Phase II study is to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 alone or in combination with G-CSF in Patients with Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female 18 to 75 years of age inclusive;
•Patients with confirmed pathology diagnosis of MM, NHL or HD;
•Potential candidate for autologous stem cell transplantation at Investigator's discretion;
•4 weeks since last cycle of chemotherapy prior to the study drug administration;
•Total dose of melphalan received 200 mg in the most recent chemotherapy treatment;
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
•Recovered from all acute toxic effects of prior chemotherapy at Investigator's discretion;
•White blood cell (WBC) count 3.0 x 109/L on screening laboratory assessments;
•Absolute neutrophil count 1.5 x 109/L on screening laboratory assessments;
•Platelet count 100 x 109/L on screening laboratory assessments;
+10 more criteria

Exclusion Criteria

•Received radiation therapy to the pelvis;
•Received \> 6 cycles of lenalidomide;
•Evidence of bone marrow involvement of lymphoma in NHL patients;
•Failed previous stem cell collection \[failed to collect 2 x 106 CD34+ cells/kg within 4 leukapheresis sessions after receiving granulocyte colony-stimulating factor (G-CSF)\];
•Patients who have undergone previous stem cell transplantation procedure;
•Received G-CSF within 2 weeks prior to the study drug administration;
•History of other cancer within the past 5 years excluding MM, NHL, HD, basal cell or squamous cell carcinoma of the skin;
•History of other hematologic disorders including bleeding or thromboembolic disease being treated with anti-coagulant;
•History of poor and uncontrollable cardiovascular or pulmonary disease such as myocardial infarction, cardiac arrhythmias, transient ischemic attack, stroke or Chronic Obstructive Pulmonary Disease (COPD) patients hospitalized more than two times a year due to underlying disease;
•Diagnosis of sickle cell anemia or documented sickle cell trait;
+7 more criteria

Locations (1)

Stony Brook University Hospital

Stony Brook, New York, United States

Key Dates

Start Date

October 1, 2012

Primary Completion Date

July 1, 2013

Completion Date

July 1, 2013

Last Updated

April 19, 2021

Enrollment

ACTUAL participants

Conditions

Multiple MyelomaNon-hodgkin's LymphomaHodgkin's Disease

Interventions

TG-0054

DRUG

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

NCT06152575

Multiple Myeloma

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RECRUITINGPHASE2

Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma

NCT06179888

Multiple Myeloma

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RECRUITINGPHASE1/PHASE2

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 19, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 Alone or in Combination With G-CSF in Patients With Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease

Inclusion Criteria

Exclusion Criteria

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

Elranatamab in R/R Multiple Myeloma