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A Phase II Trial to Determine the Effect of Imetelstat (GRN163L) on Patients With Previously Treated Multiple Myeloma

Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

A Phase II Trial to Determine the Effect of Imetelstat (GRN163L) on Patients With Previously Treated Multiple Myeloma

Inclusion Criteria:

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

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.

Exclusion Criteria:

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

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of Improvement in Response

Outcome Description:

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).

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Stephen Kelsey, MD, FRCP, FRC Path.

Investigator Role:

Study Director

Investigator Affiliation:

Geron Corporation


United States: Food and Drug Administration

Study ID:




Start Date:

November 2010

Completion Date:

December 2013

Related Keywords:

  • Multiple Myeloma
  • imetelstat
  • imetelstat sodium
  • GRN163L
  • telomerase inhibitor
  • telomerase inhibition
  • multiple myeloma
  • myeloma
  • myeloma progenitor cells
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Sidney Kimmel Cancer Center Johns Hopkins HospitalBaltimore, Maryland  21231
University of Maryland Medical Center - M & S Greenebaum Cancer CenterBaltimore, Maryland  21201