Safety and Dose Study of GRN163L and Velcade to Treat Patients With Refractory or Relapsed Myeloma

NCT00718601 | Completed Phase 1

• 1 other identifier: GRN163L CP14A011
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine safety and the maximum tolerated dose (MTD) of GRN163L and Velcade with and without Decadron when administered to patients with refractory or relapsed multiple myeloma.

Conditions

Multiple Myeloma

Keywords

Myeloma; Multiple Myeloma; Relapsed Multiple Myeloma; Refractory Multiple Myeloma; Relapsed or Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose

  First 3 weeks

Secondary Outcomes (1)

• Safety, PK and efficacy

  Baseline to 28 days after last dose of treatment

Study Arms (1)

1

EXPERIMENTAL

3+3 cohort dose escalation

Drug: Imetelstat Sodium (GRN163L)

Interventions

Imetelstat Sodium (GRN163L) DRUG

25% dose escalation infused over 2 hours weekly

1

Eligibility Criteria

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

You may qualify if:

• Confirmed diagnosis of multiple myeloma (either secretory or nonsecretory disease)
• Relapsed or refractory disease
• ECOG performance status 0-2
• Adequate hepatic/renal function and platelet count
• If previously treated with an anthracycline, anthracenedione, or trastuzumab, must have left ventricular ejection fraction \> 50%
• Fully recovered from any previous cancer treatments and/or major surgery

You may not qualify if:

• Prior allogeneic bone marrow transplant, including syngeneic transplant
• Bone marrow transplant within 12 weeks prior to study
• Known intracranial disease or epidural disease
• Inability to tolerate Velcade
• Inability to tolerate Decadron
• Prior malignancy (within the last 3 years)
• Clinically significant cardiovascular disease or condition
• Active or chronically recurrent bleeding (eg, active peptic ulcer disease
• Prolongation of PT or aPTT \> the ULN or fibrinogen \< the LLN
• Clinically relevant active infection
• Serious co-morbid medical conditions, including cirrhosis and chronic obstructive or chronic restrictive pulmonary disease
• Any other cancer therapy within 4 weeks prior to study, with nitrosourea within 6 weeks prior to study
• Investigational therapy within 4 weeks prior to study
• Anti-platelet therapy within 2 weeks prior to study, other than low dose aspirin prophylaxis therapy and low dose heparin administration for management of IV access devices
• Radiation therapy within 4 weeks prior to study

Sponsors & Collaborators

• Geron Corporation: lead

Study Sites (3)

Karmanos Cancer Center

Detroit, Michigan, 48201, United States

Location

St. Vincent's Comprehensive Cancer Center

New York, New York, 10011, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell; Recurrence

Interventions

imetelstat

Condition Hierarchy (Ancestors)

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen Kelsey, MD

  Geron Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2008
• First Posted: July 18, 2008
• Study Start: July 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 24, 2015

Record last verified: 2015-12

Locations

US (3)