Multiple MyelomaPhase 2NCT00423644
A Phase II Trial of ZIO-101 in Advanced Multiple Myeloma: Protocol SGL2001b
A Phase 2 study testing Darinaparson in people with Multiple Myeloma, run by Alaunos Therapeutics at 8 sites in United States.
Trial summary
The study of safety of a new organic arsenic compound in the treatment of advanced 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?
- Darinaparson
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 8 sitesUnited States
- Study dates
- Jan 2007to 21 Dec 2008
- Phase
- Phase 2
- 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
- Subjects with a confirmed diagnosis of active multiple myeloma with measurable protein criteria present to evaluate response. Measurable disease is defined as having at least one of the following criteria within 28 days prior to registration:
- Serum M-protein level > 0.5 gm/dl (10.0 g/L) measured by serum protein electrophoresis.
- Urinary M-protein excretion > 0.2 g/24 hours by urine electrophoresis.
- Subjects must have relapsed or resistant disease, defined as either relapsing or is resistant after > 2 lines of prior therapy for myeloma. A minimum of 42 days must have elapsed since prior autologous or allogeneic transplant;
- Informed consent compliant with ZIOPHARM policies and approved by the Human Investigation Review Committee with jurisdiction over the site;
- ECOG performance score ≤ 1;
Show all 13Show fewer
- No chemotherapy, bortezomib, lenalidomide, thalidomide, arsenic trioxide, radiation therapy or immune therapy for ≥ 3 w and recovered from all treatment associated toxicities prior to registration; 5a. Patients may not receive more than the equivalent of 10 mg of prednisone per day for 2 weeks prior to registration.
- Age ≥ 18;
- Granulocytes ≥ 1.0 x 109/L; platelets ≥ 50 x 109/L;
- Bilirubin ≤ 2.0 mg/dL; AST and ALT ≤ 2 x ULN;
- Creatinine ≤ 3 X ULN.
- No investigational agents within 28 days of study entry.
- Males who agree to use a double-barrier method of birth control, (Double barrier method is defined as: a condom and either a diaphragm/cervical cap or an IUD).
Who cannot join
- NYHA functional class ≥ 3, myocardial infarction ≤ 6 mo or uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; QTc ≥ 450msec; AV-block ≥ grade-2 or LBBB;
- Women of childbearing potential. (Non-childbearing potential is defined as: surgical sterilization or 2 years post-menopausal)
- Active infection requiring antibiotics;
- Allergy to ZIO-101 or its excipients;
- Baseline confusion or dementia, defined as grade > 2 CTCAE Version 3.0;
- Significant neurotoxicityneuropathology, defined as grade > 2 neurotoxicity neuropathology per CTCAE Version 3.0;
- Prior seizures ≥ grade-3 in CTC v.3 criteria.
- Prior history of neurological deficits (e.g., stroke, dementia, ischemia) that has the potential to confound a post-dose neurological assessment
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Bethesda, Maryland
Study site
Buffalo, New York
Study site
Charlotte, North Carolina
Study site
Glendale, Arizona
Study site
Santa Barbara, California
Study site
Santa Rosa, California
Study site
Sioux Falls, South Dakota
Study site
West Hollywood, California
About this study
The study of safety of a new organic arsenic compound in the treatment of advanced multiple myeloma
- Conditions
- Multiple Myeloma
- Being tested
- Darinaparson
- Keywords
- Multiple Myeloma, arsenic, cancer study, failed treatment
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarinaparsonDrug
Also called ZIO-101
420 mg/m2 of Darinaparsin given twice weekly for three weeks, followed by one week of rest for up to six months
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: Darinaparson |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Measured: 6 months
Secondary outcomes (2)
Survival (overall and progression free)
Measured: 6 months
toxicities
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study startJan 2007
- Primary completion21 Dec 2007
- Study completion21 Dec 2008
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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaunos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00423644
- Sponsor's protocol ID
- SGL2001b
- Status last verified
- Sep 2026
- First submitted
- 16 Jan 2007
- Last updated
- 29 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of ZIO-101 in Advanced Multiple Myeloma: Protocol SGL2001b
- ClinicalTrials.gov ID
- NCT00423644
- Acronym / sponsor ID
- SGL2001b
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, arsenic, cancer study, failed treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Alaunos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- 21 Dec 2007 (actual)
- Study completion
- 21 Dec 2008 (actual)
- First posted
- 18 Jan 2007 (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 study of safety of a new organic arsenic compound in the treatment of advanced multiple myeloma
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Darinaparson |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects with a confirmed diagnosis of active multiple myeloma with measurable protein criteria present to evaluate response. Measurable disease is defined as having at least one of the following criteria within 28 days prior to registration:
- Subjects must have relapsed or resistant disease, defined as either relapsing or is resistant after > 2 lines of prior therapy for myeloma. A minimum of 42 days must have elapsed since prior autologous or allogeneic transplant;
- Informed consent compliant with ZIOPHARM policies and approved by the Human Investigation Review Committee with jurisdiction over the site;
- ECOG performance score ≤ 1;
- No chemotherapy, bortezomib, lenalidomide, thalidomide, arsenic trioxide, radiation therapy or immune therapy for ≥ 3 w and recovered from all treatment associated toxicities prior to registration; 5a. Patients may not receive more than the equivalent of 10 mg of prednisone per day for 2 weeks prior to registration.
Key exclusion criteria (8 listed)
- NYHA functional class ≥ 3, myocardial infarction ≤ 6 mo or uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; QTc ≥ 450msec; AV-block ≥ grade-2 or LBBB;
- Women of childbearing potential. (Non-childbearing potential is defined as: surgical sterilization or 2 years post-menopausal)
- Active infection requiring antibiotics;
- Allergy to ZIO-101 or its excipients;
- Baseline confusion or dementia, defined as grade > 2 CTCAE Version 3.0;
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 |
|---|---|---|
| DarinaparsonAlso: ZIO-101420 mg/m2 of Darinaparsin given twice weekly for three weeks, followed by one week of rest for up to six months | Drug | Single Arm |
Primary outcome
Response Rate
Time frame: 6 months
2 secondary outcomes
Survival (overall and progression free)
Time frame: 6 months
toxicities
Time frame: 6 months
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 29 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Darinaparson in people with Multiple Myeloma, run by Alaunos Therapeutics at 8 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 13 inclusion and 8 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 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Response Rate (time frame: 6 months). 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 29 Sep 2026.