Open Label Study With Imetelstat to Determine Effect of Imetelstat in Patients w/ Previously Treated Multiple Myeloma

NCT01242930 | Completed Phase 2

• 1 other identifier: CP14B013
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

This is an open label Phase II study to determine the rate of improvement in response of patients with previously treated multiple myeloma to imetelstat alone or in combination with lenalidomide maintenance therapy. This study will include multiple myeloma patients who either have achieved disease stabilization or who have achieved at least a partial response (PR) but failed to achieve a complete response (CR) after cytoreductive therapy for multiple myeloma; ie, have detectable but non-progressing disease and will most likely relapse.

Conditions

Multiple Myeloma

Keywords

imetelstat; imetelstat sodium; GRN163L; telomerase inhibitor; telomerase inhibition; multiple myeloma; myeloma; myeloma progenitor cells

Outcome Measures

Primary Outcomes (1)

• Rate of Improvement in Response

  To determine the rate of improvement in response in patients with previously treated multiple myeloma following treatment with imetelstat alone or in combination wtih lenalidomide maintenance therapy. Response will be assessed using the International Uniform Response Criteria for Multiple Myeloma (IURCMM).

  From time of first dose (Cycle 1 day 1) through end of study period (12 mos. after last participant is enrolled)

Secondary Outcomes (2)

• Progression-free Survival (PFS)

  From time of first dose (Cycle 1 day 1) through end of study (12 mos. after last participant is enrolled)

• Safety and Tolerability

  From time of first dose (Cycle 1 day 1) through end of study (12 mos. after last participant is enrolled)

Study Arms (2)

Imetelstat (7.5 mg/kg)

EXPERIMENTAL

Imetelstat (7.5 mg/kg) with or without lenalidomide standard of care

Drug: Imetelstat (7.5 mg/kg); Drug: lenalidomide standard of care

Imetelstat (9.4 mg/kg)

EXPERIMENTAL

Imetelstat (9.4 mg/kg) with or without lenalidomide standard of care

Drug: lenalidomide standard of care; Drug: Imetelstat (9.4 mg/kg)

Interventions

Imetelstat (7.5 mg/kg) DRUG

Imetelstat 7.5 mg/kg as a 2-hour intravenous infusion (± 10 minutes) on Days 1 and 8 of a 28-day cycle; the Day 8 dose will be omitted in patients with a prior history of bone marrow or stem cell transplant.

Also known as: GRN163L

Imetelstat (7.5 mg/kg)

lenalidomide standard of care DRUG

Patients who are receiving lenalidomide as maintenance therapy upon enrollment as part of their treatment regimen may remain on this therapy during trial participation, provided that they have received this treatment for a minimum of 3 months and demonstrate evidence of stabilization of their response.

Also known as: Revlimid

Imetelstat (7.5 mg/kg); Imetelstat (9.4 mg/kg)

Imetelstat (9.4 mg/kg) DRUG

Imetelstat 9.4 mg/kg as a 2-hour intravenous infusion (± 10 minutes) on Days 1 and 8 of a 28-day cycle; the Day 8 dose will be omitted in patients with a prior history of bone marrow or stem cell transplant.

Also known as: GRN163L

Imetelstat (9.4 mg/kg)

Eligibility Criteria

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

You may qualify if:

• Willing and able to sign an informed consent Male or female, 18 years or older Confirmed diagnosis of multiple myeloma (secretory disease) by International Myeloma Working Group Diagnostic Criteria
• Patients must meet one of the following criteria:
• o Previously treated patients with multiple myeloma who achieved at least stable disease but who have failed to achieve a complete response (CR) after a minimum of one cytoreductive therapy for multiple myeloma and have detectable but non-progressing disease. Patients must have received at least one proteasome inhibitor (eg, bortezomib) or one immunomodulatory agent (eg, thalidomide or lenalidomide) or both.
• Patients receiving lenalidomide as maintenance therapy may continue to receive this therapy provided that the patient has been on this maintenance therapy for a minimum of 3 months and has evidence of disease stabilization.
• Disease stabilization will be defined as an M protein that varies ≤ 25% over the three measurements or remains under 0.5 g/dL whichever is smaller.
• ECOG performance status 0-2 Life expectancy ≥ 3 months
• Laboratory criteria (within 14 days of first study drug administration):
• ANC ≥ 1000/μL
• Platelet count ≥ 50 x 103/μL (without transfusion support within 2 weeks prior to first study drug administration)
• Hemoglobin ≥ 8.0 g/dL
• Serum creatinine ≤ 3 x the upper limit of normal (ULN)
• AST (SGOT) and ALT (SGPT) ≤ 2.5 x the upper limit of normal (ULN), unless due to disease.
• Must have fully recovered from any previous cancer treatments and/or major surgery.
• Women of childbearing potential must have a negative serum pregnancy test and agree to use effective birth control (two reliable forms of contraception) during and for at least 12 weeks after the last treatment.
• Males must agree to use effective birth control for themselves or their partner during and for 12 weeks after the last treatment with imetelstat. For those patients receiving lenolidomide, males must use latex condom during sexual contact with women of childbearing potential even if they have undergone a successful vasectomy.

You may not qualify if:

• Women who are pregnant or breast feeding Prior radioimmunotherapy. Known intracranial disease or epidural disease. Patients with lytic lesions of the cranium or spine secondary to myeloma are eligible to enroll.
• Clinically significant cardiovascular disease or condition including:
• Congestive heart failure (CHF) requiring therapy
• Need for antiarrhythmic therapy for a ventricular arrhythmia
• Severe conduction disturbance
• Angina pectoris requiring therapy
• Uncontrolled hypertension per the Investigator's discretion
• New York Heart Association Class II, III, or IV cardiovascular disease Active or chronically recurrent bleeding (eg, active peptic ulcer disease) 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 including chemotherapy, monoclonal antibody, signal transduction inhibitor, immunotherapy, glucocorticoid (except topical or as premedication), thalidomide within 3 weeks prior to first study drug administration.
• Investigational therapy within 4 weeks prior to first study drug administration.
• Major surgery within 4 weeks prior to first study drug administration (central line placement is allowed) Anti-platelet therapy within 2 weeks prior to first study drug administration, other than low dose aspirin prophylaxis therapy.
• Full dose anticoagulation. Prophylactic low dose administration for management of IV access devices is allowed.
• Known positive serology for human immunodeficiency virus (HIV. Any other severe, acute, or chronic medical or psychiatric condition, laboratory abnormality, or difficulty complying with protocol requirements that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for this study

Sponsors & Collaborators

• Geron Corporation: lead

Study Sites (2)

University of Maryland Medical Center - M & S Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Sidney Kimmel Cancer Center Johns Hopkins Hospital

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

imetelstat; GRN163L peptide; Lenalidomide

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

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ted Shih, PharmD

  Geron Corporation

  STUDY DIRECTOR

• Carol Ann Huff, M.D.

  Sidney Kimmel Cancer Center at Johns Hopkins Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 16, 2010
• First Posted: November 17, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 12, 2016

Record last verified: 2016-04

Locations

US (2)