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

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and the maximum tolerated dose (MTD) of GRN163L when administered to patients with refractory or relapsed multiple myeloma.

Detailed Description
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GRN163L is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells. Inhibition of telomerase may result in antineoplastic effects.

Official Title
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A Phase 1 Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of GRN163L in Patients With Refractory or Relapsed Multiple Myeloma

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Imetelstat Sodium (GRN163L)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of multiple myeloma (either secretory or nonsecretory disease) Relapsed or refractory disease At least two prior treatment regimens 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% Exclusion Criteria: Prior allogeneic bone marrow transplant, including syngeneic transplant Known intracranial disease or epidural disease 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 Symptomatic hyperviscosity syndrome Any other cancer therapy within 3 weeks prior to study, except for mitomycin C, nitrosoureas, or high-dose chemotherapy with stem cell support 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 Major surgery within 4 weeks prior to study Active autoimmune disease requiring immunosuppressive therapy Known positive serology for HIV

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>3+3 cohort dose escalation | Drug: Imetelstat Sodium (GRN163L)<br>* 25% dose escalation infused over 2 hours weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and MTD |  | First 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK, PD, and efficacy |  | Baseline to end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myeloma, Multiple Myeloma, Relapsed Multiple Myeloma, Refractory Multiple Myeloma, Relapsed or Refractory Multiple Myeloma