Efficacy Study of CYT997 in Multiple Myeloma

NCT00664378 | Terminated Phase 2 DMC

• 1 other identifier: CCL07001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical research study that is designed to test the safety of CYT997 when given to patients with multiple myeloma and to test if CYT997 has any activity against that cancer.

Conditions

Relapsed and Refractory Multiple Myeloma

Keywords

Multiple myeloma, relapsed, refractory

Outcome Measures

Primary Outcomes (1)

• Overall response rate to CYT997 when used to treat patients with relapsed or refractory multiple myeloma

  The overall response rate to CYT997 when used to treat patients with relapsed or refractory multiple myeloma once every 3 week cycle

  Baseline to study completion

Secondary Outcomes (4)

• Number of cycles required to achieve maximum response

  Baseline to study completion

• Overall survival

  Baseline to study completion

• Safety and tolerability

  Baseline to study completion

• Time to disease progression

  Baseline to study completion

Study Arms (1)

I

EXPERIMENTAL

CYT997

Drug: CYT997

Interventions

CYT997 DRUG

Intravenous infusion (24h); 202mg/m2 on days 1 and 8 of a 21 day cycle

I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of multiple myeloma per International Working Group (IWG) criteria
• Have received at least 1 but no more than 4 prior lines of therapy
• Have failed to respond to the most recently administered anti-myeloma therapy
• Have a life expectancy of at least 3 months
• Eastern Cooperative Oncology Group (ECOG) performance status \< 3
• At registration absolute neutrophil count \> 1x10\^9/L and platelet count \> 50 x 10\^9/L unsupported
• At registration bilirubin less than 1.5 x upper limit of normal and transaminases less than 2 x upper limit of normal and serum creatinine less than 0.19 mmol/L
• Written informed consent
• Must agree to adequate contraceptive measure if indicated

You may not qualify if:

• Patients with monoclonal gammopathy of undetermined significance
• Known or suspected hypersensitivity to CYT997
• Patient with uncontrolled intercurrent illness
• Active infections or other illnesses that precludes chemotherapy administration or patient compliance.
• Pregnant or lactating women.
• Patients who have received any other investigational agents in the last 3 weeks prior to the start of treatment.
• Patients with the following conditions will be excluded:
• myocardial infarction or stroke within 6 months
• unstable angina pectoris or acute ischemic changes on ECG
• history of diabetic retinopathy
• symptomatic peripheral arterial disease
• major surgery in the last 30 days
• Patients with uncontrolled diarrhea despite optimal medication and those with any history of acute gastrointestinal bleeding
• Patients with a baseline prolongation of the QTc interval of Common Terminology Criteria (CTC) Grade 1 (QTc \> 0.45-0.47 sec) or greater
• Patients with impaired cardiac function or clinically significant cardiac diseases, including any one of the following:

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Interventions

CYT997

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Andrew Spencer, Assoc Prof.

  Myeloma Research Group, The Alfred Hospital, Melbourne

  PRINCIPAL INVESTIGATOR

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 18, 2008
• First Posted: April 22, 2008
• Study Start: January 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: June 8, 2018

Record last verified: 2013-04

Locations

AU (1)