Multiple MyelomaPhase 2NCT01242930
Open Label Study With Imetelstat to Determine Effect of Imetelstat in Patients w/ Previously Treated Multiple Myeloma
A Phase 2 study testing Imetelstat (7.5 mg/kg) and Imetelstat (9.4 mg/kg) in people with Multiple Myeloma, run by Geron Corporation at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Imetelstat (7.5 mg/kg) and Imetelstat (9.4 mg/kg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2010to Nov 2014
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland Medical Center - M & S Greenebaum Cancer Center
Baltimore, Maryland, 21201
Sidney Kimmel Cancer Center Johns Hopkins Hospital
Baltimore, Maryland, 21231
About this study
Official title: A Phase II Trial to Determine the Effect of Imetelstat (GRN163L) on Patients With Previously Treated Multiple Myeloma
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
- Being tested
- Imetelstat (7.5 mg/kg), lenalidomide standard of care, Imetelstat (9.4 mg/kg)
- Keywords
- imetelstat, imetelstat sodium, GRN163L, telomerase inhibitor, telomerase inhibition, multiple myeloma, myeloma, myeloma progenitor cells
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imetelstat (7.5 mg/kg)Drug
Also called GRN163L
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.
lenalidomide standard of careDrug
Also called Revlimid
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.
Imetelstat (9.4 mg/kg)Drug
Also called GRN163L
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.
| Study group | Role | What they receive |
|---|---|---|
| Imetelstat (7.5 mg/kg) | Experimental | Imetelstat (7.5 mg/kg) with or without lenalidomide standard of care Receives: 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 Receives: Drug: lenalidomide standard of care; Drug: Imetelstat (9.4 mg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
As assessed from Cycle 1 Day 1 to first evidence of PD as defined by IURCMM, or death, whichever occurs first.
Measured: From time of first dose (Cycle 1 day 1) through end of study (12 mos. after last participant is enrolled)
Safety and Tolerability
The safety and tolerability of imetelstat will be assessed by the incidence, nature, relatedness and severity of adverse events, laboratory abnormalities and vital signs.
Patients who develop Grade 3 or 4 cytopenias (other than lyphophenia and/or leukopenia alon) will receive addiontal safety monitoring for reversibility.
Measured: From time of first dose (Cycle 1 day 1) through end of study (12 mos. after last participant is enrolled)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geron Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joe Eid, Study director, Geron CorporationCarol Ann Huff, M.D., Principal investigator, Sidney Kimmel Cancer Center at Johns Hopkins Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242930
- Sponsor's protocol ID
- CP14B013
- Status last verified
- Jun 2026
- First submitted
- 16 Nov 2010
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No