Trials Sponsors Conditions Drugs Pricing

Conditions

Multiple Myeloma

Keywords

multiple myelomaproteasome inhibitorrelapsedrefractory

Outcome Measures

Primary Outcomes (1)

Number of Patients Exhibiting a Given Overall Response as Determined by Investigator
Disease response and progression were determined by the investigator using the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). Overall response rate includes patients with a best response of PR of better. Stringent complete response (CR) includes immunophenotypic CR and molecular CR in addition to stringent CR.
Through study completion, an average of 6.09 weeks.

Secondary Outcomes (6)

Duration of MRZ Treatment
Through study completion, an average of 6.09 weeks.
Number of Cycles of Marizomib (MRZ)
Through study completion, an average of 6.09 weeks.
Number of Patients Receiving Marizomib (MRZ) in Each Cycle
Through study completion, an average of 6.09 weeks.
Number of Patients With Treatment Emergent Adverse Events (TEAEs)
Through study completion, an average of 6.09 weeks.
Number of Treatment Emergent Adverse Events (TEAEs)
Through study completion, an average of 6.09 weeks.
+1 more secondary outcomes

Study Arms (1)

MRZ 0.5 mg/m^2

EXPERIMENTAL

Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles

Drug: MRZ 0.5 mg/m^2

Interventions

MRZ 0.5 mg/m^2Drug

NPI-0052 0.5 mg/m2 administered IV over 2 hours on Days 1, 4, 8, and 11 in each 21-day cycle

Also known as: Marizomib, NPI-0052

MRZ 0.5 mg/m^2

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age 18 years.
Karnofsky Performance Status (KPS) score 70%.

Sponsors & Collaborators

Celgene
Industrylead

Study Sites (6)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

University of Chicago, School of Medicine

Chicago, Illinois, 60637, United States

University of Maryland

Baltimore, Maryland, 21201, United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

University of Michigan

Ann Arbor, Michigan, 48109, United States

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Related Publications (34)

Blade J, Samson D, Reece D, Apperley J, Bjorkstrand B, Gahrton G, Gertz M, Giralt S, Jagannath S, Vesole D. Criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation. Myeloma Subcommittee of the EBMT. European Group for Blood and Marrow Transplant. Br J Haematol. 1998 Sep;102(5):1115-23. doi: 10.1046/j.1365-2141.1998.00930.x. No abstract available.
PMID: 9753033BACKGROUND
Bross PF, Kane R, Farrell AT, Abraham S, Benson K, Brower ME, Bradley S, Gobburu JV, Goheer A, Lee SL, Leighton J, Liang CY, Lostritto RT, McGuinn WD, Morse DE, Rahman A, Rosario LA, Verbois SL, Williams G, Wang YC, Pazdur R. Approval summary for bortezomib for injection in the treatment of multiple myeloma. Clin Cancer Res. 2004 Jun 15;10(12 Pt 1):3954-64. doi: 10.1158/1078-0432.CCR-03-0781. No abstract available.
PMID: 15217925

MeSH Terms

Conditions

Multiple MyelomaRecurrence

Interventions

marizomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic Disorders

Results Point of Contact

Title: Associate Director of Clinical and Regulatory Operations
Organization: Triphase Accelerator

Study Officials

Steven D Reich, MD
Triphase Research and Development I Corp
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

15 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 13, 2007

First Posted

April 17, 2007

Study Start

March 2007

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

Patients with Grade \>1 proteinuria (1 g/24 hour excluding M proteins = urine paraprotein subtracted from total urine protein), untreated urinary tract infection, as well as any pre existing kidney disease (acute or chronic) that in the Investigator's assessment would impose excessive risk to the patient.
Patients with evidence of mucosal or internal bleeding and/or platelet refractory (ie, unable to maintain platelet count 30 × 109/L).
Significant cardiac disease defined as:
Patients with congenital long QT syndrome;
Congestive heart failure of Class III or IV of the NYHA classification;
History of myocardial infarction or ischemia within 12 months of study enrollment.
Abnormal left ventricular ejection fraction (LVEF) (\< lower limit of normal as defined by the study site for a patient of that age) by echocardiogram (ECHO) or multiple-gated angiography (MUGA).
Patients with a prior hypersensitivity reaction of CTCAE Grade \>3 to therapy containing propylene glycol or ethanol.
Pregnant or breast-feeding women. Female patients must be postmenopausal or surgically sterile, or they must agree to use acceptable methods of birth control (ie, a hormonal contraceptive with barrier method, intra-uterine device, diaphragm with spermicidal or condom with spermicide, or abstinence) for the duration of the study and for one month following study completion. Female patients with childbearing potential must have a negative serum pregnancy test within the 7 days before the first NPI-0052 administration. Male patients must be surgically sterile or agree to use an acceptable method of contraception.
Active uncontrolled bacterial or fungal infection requiring systemic therapy; infection requiring parenteral antibiotics.
Known to be HIV positive or positive and active for hepatitis A, B, or C.
Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient. Examples of such conditions include infection requiring parenteral or oral anti-infective treatment or any altered mental status or psychiatric condition that would interfere with an understanding of the informed consent.
Unwilling or unable to comply with procedures required in this protocol.

Phase 2 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

MRZ 0.5 mg/m^2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

Related Publications (34)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

MRZ 0.5 mg/m^2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

Related Publications (34)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations