Multiple MyelomaPhase 1NCT00718601
Safety and Dose Study of GRN163L and Velcade to Treat Patients With Refractory or Relapsed Myeloma
A Phase 1 study testing Imetelstat Sodium (GRN163L) in people with Multiple Myeloma, run by Geron Corporation at 3 sites in United States.
Trial 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. 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 Sodium (GRN163L)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2008to Oct 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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)
Show all 18Show fewer
- 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
- Major surgery within 4 weeks prior to study
- Active autoimmune disease requiring immunosuppressive therapy
- Known positive serology for HIV
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Karmanos Cancer Center
Detroit, Michigan, 48201
St. Vincent's Comprehensive Cancer Center
New York, New York, 10011
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: A Phase I Study of GRN163L in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
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.
Read the detailed description
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.
- Conditions
- Multiple Myeloma
- Being tested
- Imetelstat Sodium (GRN163L)
- Keywords
- Myeloma, Multiple Myeloma, Relapsed Multiple Myeloma, Refractory Multiple Myeloma, Relapsed or Refractory Multiple Myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imetelstat Sodium (GRN163L)Drug
25% dose escalation infused over 2 hours weekly
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 3+3 cohort dose escalation Receives: Drug: Imetelstat Sodium (GRN163L) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Measured: First 3 weeks
Secondary outcomes (1)
Safety, PK and efficacy
Measured: Baseline to 28 days after last dose of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2011
- Study completionOct 2011
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 1
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geron Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Kelsey, MD, Study director, Geron Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00718601
- Sponsor's protocol ID
- GRN163L CP14A011
- Status last verified
- Dec 2015
- First submitted
- 16 Jul 2008
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of GRN163L in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00718601
- Acronym / sponsor ID
- GRN163L CP14A011
- Conditions
- Multiple Myeloma
- Keywords
- Myeloma, Multiple Myeloma, Relapsed Multiple Myeloma, Refractory Multiple Myeloma, Relapsed or Refractory Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Geron CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 18 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Imetelstat Sodium (GRN163L)3+3 cohort dose escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imetelstat Sodium (GRN163L)25% dose escalation infused over 2 hours weekly | Drug | 1 |
Primary outcome
Maximum tolerated dose
Time frame: First 3 weeks
1 secondary outcome
Safety, PK and efficacy
Time frame: Baseline to 28 days after last dose of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Kelsey, MD study director
Geron Corporation
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Imetelstat Sodium (GRN163L) in people with Multiple Myeloma, run by Geron Corporation at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (time frame: First 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2015.