MedDataX Logo

Safety and Efficacy Study of Imexon for Treatment of Multiple Myeloma Patients

NCT ID: NCT00327249

Last Updated: 2009-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

AMP-007 is a Phase 1/2 study for the treatment of advanced, previously treated multiple myeloma. The first phase of the study is designed to determine a safe dose of imexon that can be given to patients with advanced, previously-treated multiple myeloma. The Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether imexon can improve the outcome for patients with multiple myeloma

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study Comparing Therapy for Advanced Relapsed/Refractory Multiple Myeloma With and Without Dexamethasone

NCT06561854

Multiple Myeloma Relapse Multiple Myeloma
RECRUITING PHASE3

A Study of Ixazomib, Given With Dexamethasone in Adults With Multiple Myeloma

NCT03170882

Relapsed and/or Refractory Multiple Myeloma
COMPLETED PHASE2

A Phase 1 Study in Subjects With Relapsed or Refractory Multiple Myeloma

NCT02561962

Multiple Myeloma
COMPLETED PHASE1

A Study to Assess AMG 701 Montherapy, or in Combination With Pomalidomide, With or Without, Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

NCT03287908

Relapsed/Refractory Multiple Myeloma
TERMINATED PHASE1

Bortezomib-Melphalan Conditioning Regimen vs Melphalan for Frontline Transplant Eligible Patients With Multiple Myeloma

NCT02197221

Multiple Myeloma
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Myeloma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

imexon

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Advanced myeloma, with measurable disease as defined in the protocol.
* Prior treatment, at least 2 prior regimens are required. This may include prior treatment with investigational products.
* Able to perform the activities of daily living.
* Off prior therapy for at least 2-4 weeks depending on the drug.
* Blood counts and blood chemistries in or near normal range.
* If female, neither pregnant nor nursing.
* Willing to use contraceptives to prevent pregnancy.
* No other serious illnesses.
* No other active malignancy.
* No serious infections.
* No current other drug therapy for the myeloma except for steroid therapy under certain circumstances. Biphosphonate therapy is permitted.
* Prior radiation is permitted.

Exclusion Criteria

* Use of corticosteroids for amyloid disorders, or high dose chronic steroids.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AmpliMed Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

AmpliMed

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Investigational Site 025

Little Rock, Arkansas, United States

Site Status

Investigational Site 008

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AMP-007

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study of Carfilzomib Weekly Plus Melphalan and Prednisone in Untreated Symptomatic Elderly Multiple Myeloma
NCT02302495 COMPLETED PHASE2
A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant
NCT06932562 RECRUITING PHASE3
Study of Oral Ixazomib in Combination With Melphalan and Prednisone in Participants With Newly Diagnosed Multiple Myeloma
NCT01335685 COMPLETED PHASE1/PHASE2
Safety, Efficacy, and Pharmacodynamics of a 60-Minute Infusion of Carfilzomib for Progressive Multiple Myeloma
NCT01792102 UNKNOWN PHASE1/PHASE2
Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
NCT01832727 TERMINATED PHASE1/PHASE2
S1211 Bortezomib, Dexamethasone, and Lenalidomide With or Without Elotuzumab in Treating Patients With Newly Diagnosed High-Risk Multiple Myeloma
NCT01668719 ACTIVE_NOT_RECRUITING PHASE1/PHASE2
A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant
NCT02181413 COMPLETED PHASE3
Autologous or Syngeneic Stem Cell Transplant Followed by Donor Stem Cell Transplant and Bortezomib in Treating Patients With Newly Diagnosed High-Risk, Relapsed, or Refractory Multiple Myeloma
NCT00793572 COMPLETED PHASE2
Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
NCT01734928 COMPLETED PHASE3
A Study of F182112 in the Treatment of Patients With Relapsed or Refractory Multiple Myeloma
NCT07312188 RECRUITING PHASE2
Intravenous rhMBL in Patients With Multiple Myeloma Receiving Chemotherapy Followed by Stem Cell Transplant
NCT00388999 COMPLETED PHASE1
2017-03: A Single-Arm, Open-label Study of Anti-Signaling Lymphocytic Activation Molecule F7 (Anti-SLAMF7) Monoclonal Antibody (mAb) Therapy After Autologous Stem Cell Transplant in Patients With Multiple Myeloma
NCT03168100 WITHDRAWN PHASE2
Ixazomib, ONC201, and Dexamethasone in Relapsed/Refractory Multiple Myeloma
NCT03492138 TERMINATED PHASE1/PHASE2
A Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Participants With Relapsed/Refractory (r/r) Multiple Myeloma (MM)
NCT03439280 COMPLETED PHASE1/PHASE2
IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma
NCT01850524 COMPLETED PHASE3
Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma
NCT02412878 COMPLETED PHASE3
UARK 2015-03 A Phase II Trial of a Novel Proteasome/IMiD Combination
NCT02578121 WITHDRAWN PHASE2
Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Lemzoparlimab With or Without Oral/IV Dexamethasone and in Combination With Oral/IV/Subcutaneous Anti-Myeloma Regimens in Adult Participants With Multiple Myeloma
NCT04895410 TERMINATED PHASE1
A Study of Tanespimycin (KOS-953) in Patients With Relapsed-refractory Multiple Myeloma
NCT00514371 COMPLETED PHASE2/PHASE3
A Study of Oprozomib, Pomalidomide, and Dexamethasone in Adults With Primary Refractory or Relapsed and Refractory Multiple Myeloma
NCT01999335 TERMINATED PHASE1
A Multi-center Open-label Phase 2 Study of Ixazomib, Iberdomide and Dexamethasone in Elderly Patients With Multiple Myeloma at First Relapse."
NCT04998786 ACTIVE_NOT_RECRUITING PHASE2
2015-09: a Phase II Randomized, Open-label Study of Anti-signaling Lymphocytic Activation Molecule Monoclonal Antibody During Maintenance Therapy
NCT03000634 WITHDRAWN PHASE2
A Study of Real-life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma Who Received at Least 3 Prior Lines of Therapy Including Proteasome Inhibitor (PI), Immunomodulatory Drug (IMID), and Cluster of Differentiation 38 (CD38) Monoclonal Antibody Treatment
NCT04035226 COMPLETED
Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma
NCT01478048 COMPLETED PHASE2
Study of Treatment for Newly Diagnosed Multiple Myeloma Patients Older Than 65 Years With Sequential Melphalan/Prednisone/Velcade (MPV) Followed by Revlimid/Low Dose Dexamethasone (Rd) Versus Alternating Velcade/Melphalan/Prednisone (MPV) With Revlimid/Low Dose Dexamethasone
NCT01237249 COMPLETED PHASE2