DS Stage II Plasma Cell MyelomaPhase 2NCT00066638
FR901228 in Treating Patients With Relapsed or Refractory Multiple Myeloma
A Phase 2 study testing Romidepsin and Laboratory Biomarker Analysis in people with DS Stage II Plasma Cell Myeloma and DS Stage III Plasma Cell Myeloma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Drugs used in chemotherapy such as FR901228 use different ways to stop cancer cells from dividing so they stop growing or die. Phase II trial to study the effectiveness of FR901228 in treating patients who have relapsed or refractory multiple myeloma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DS Stage II Plasma Cell Myeloma, DS Stage III Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
- What is being tested?
- Romidepsin and Laboratory Biomarker Analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Mar 2011
- 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
- Patients must have histologically or cytologically confirmed stage IIa or IIIa multiple myeloma
- Patient has progressive disease and has had 1, 2, 3, or 4 prior lines of therapy
- Bilirubin < 2.0 mg/dL
- SGOT/SGPT =< 2.5 X institutional upper limit of normal
- Serum creatinine =< 1.5 mg/dl OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- Karnofsky Performance Status equal or greater than 70%; KPS 60% will be allowed if reduced KPS is due to advanced skeletal disease
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- Measurable disease as defined by serum M protein >= 1.0 gm/dl measured by serum protein electrophoresis or free light chain measurement, or quantitative immunoglobulins and/or urinary M protein excretion >= 200 mg/24 hrs
- Ejection fraction >= 50% and normal baseline EKG tracing
- No known central nervous system abnormality including neoplastic, vascular, inflammatory, degenerative or epilepsy
- Life expectancy of greater than 12 weeks
- Leukocytes >= 3,000/uL
- Absolute neutrophil count >= 1,500/uL
- Platelets >= 100,000/uL
- Patients in whom cytopenias are considered to be due to myeloma marrow infiltration will be allowed as long as they meet the following criteria:
- Bone marrow biopsy displaying >= normal cellularity for age and >= 50% involvement by myeloma
- ANC > 1,000 and platelets > 50,000
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign written informed consent
Who cannot join
- Administration of chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to enrollment or unresolved adverse events due to agents administered more than 4 weeks earlier
- Prior treatment with a histone deacetylase inhibitor
- Patients may not be receiving any other investigational agent
- History of second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free >= 5 years)
- Non secretory disease or plasma cell leukemia (> 2000 circulating plasma cells/uL)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to depsipeptide
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- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients with left ventricular hypertrophy or history of arrhythmias including atrial fibrillation, myocardial infarction or congestive heart failure; patients may not be taking hydrochlorothiazides
- Patients that are pregnant or lactating will be excluded from this trial
- Known HIV positivity; patients infected with the HIV virus will be excluded from this trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467-2490
About this study
Official title: A Phase 2 Study of Depsipeptide in Relapsed/Refractory Multiple Myeloma
Drugs used in chemotherapy such as FR901228 use different ways to stop cancer cells from dividing so they stop growing or die. Phase II trial to study the effectiveness of FR901228 in treating patients who have relapsed or refractory multiple myeloma
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the safety and efficacy of depsipeptide in patients with refractory or relapsed multiple myeloma (MM).
OUTLINE: This is a multicenter study.
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a stable plateau (stable paraprotein levels or urine protein excretion over 3 consecutive determinations at least 4 weeks apart) may receive maintenance therapy comprising FR901228 IV on days 1 and 15, with courses repeating every 28 days.
PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 5-12.5 months.
- Conditions
- DS Stage II Plasma Cell Myeloma, DS Stage III Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
- Being tested
- Romidepsin, Laboratory Biomarker Analysis
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RomidepsinDrug
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (romidepsin) | Experimental | Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a stable plateau (stable paraprotein levels or urine protein excretion over 3 consecutive determinations at least 4 weeks apart) may receive maintenance therapy comprising FR901228 IV on days 1 and 15, with courses repeating every 28 days. Receives: Drug: Romidepsin; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate (complete response [CR] or partial response [PR])
Measured: Up to 8 years
Event free survival
Measured: Up to 8 years
Secondary outcomes (2)
Gene array parameters
This analysis will be descriptive and will compare patterns of gene and phenotype expression pre and post therapy.
Measured: Up to 8 years
Immunochemistry parameters
This analysis will be descriptive and will compare patterns of gene and phenotype expression pre and post therapy.
Measured: Up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2003 (estimated)
- Study startJun 2003
- Primary completionMay 2007
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DS Stage II Plasma Cell MyelomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ruben Niesvizky-Iszaevich, Principal investigator, Montefiore Medical Center - Moses Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00066638
- Sponsor's protocol ID
- NCI-2012-03005
- Other IDs
- NCI-2012-03005, NCI-5996, 0403-765, 5996, N01CM62204, P30CA013330
- Status last verified
- Dec 2012
- First submitted
- 6 Aug 2003
- Last updated
- 17 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Depsipeptide in Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00066638
- Acronym / sponsor ID
- NCI-2012-03005
- Conditions
- DS Stage II Plasma Cell Myeloma, DS Stage III Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jun 2003
- Primary completion
- May 2007 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 7 Aug 2003 (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.
Drugs used in chemotherapy such as FR901228 use different ways to stop cancer cells from dividing so they stop growing or die. Phase II trial to study the effectiveness of FR901228 in treating patients who have relapsed or refractory multiple myeloma
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the safety and efficacy of depsipeptide in patients with refractory or relapsed multiple myeloma (MM).
OUTLINE: This is a multicenter study.
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a stable plateau (stable paraprotein levels or urine protein excretion over 3 consecutive determinations at least 4 weeks apart) may receive maintenance therapy comprising FR901228 IV on days 1 and 15, with courses repeating every 28 days.
PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 5-12.5 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (romidepsin) | Experimental | Drug: Romidepsin, Other: Laboratory Biomarker AnalysisPatients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a stable plateau (stable paraprotein levels or urine protein excretion over 3 consecutive determinations at least 4 weeks apart) may receive maintenance therapy comprising FR901228 IV on days 1 and 15, with courses repeating every 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients must have histologically or cytologically confirmed stage IIa or IIIa multiple myeloma
- Patient has progressive disease and has had 1, 2, 3, or 4 prior lines of therapy
- Bilirubin < 2.0 mg/dL
- SGOT/SGPT =< 2.5 X institutional upper limit of normal
- Serum creatinine =< 1.5 mg/dl OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
Key exclusion criteria (10 listed)
- Administration of chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to enrollment or unresolved adverse events due to agents administered more than 4 weeks earlier
- Prior treatment with a histone deacetylase inhibitor
- Patients may not be receiving any other investigational agent
- History of second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free >= 5 years)
- Non secretory disease or plasma cell leukemia (> 2000 circulating plasma cells/uL)
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 |
|---|---|---|
| RomidepsinGiven IV | Drug | Treatment (romidepsin) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (romidepsin) |
Primary outcome
Response rate (complete response [CR] or partial response [PR])
Time frame: Up to 8 years
Event free survival
Time frame: Up to 8 years
2 secondary outcomes
Gene array parameters
Time frame: Up to 8 years
Immunochemistry parameters
Time frame: Up to 8 years
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 17 Mar 2015.
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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.
Ruben Niesvizky-Iszaevich principal investigator
Montefiore Medical Center - Moses Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Romidepsin and Laboratory Biomarker Analysis in people with DS Stage II Plasma Cell Myeloma and DS Stage III Plasma Cell Myeloma, run by National Cancer Institute (NCI) at 1 site 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 18 inclusion and 10 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 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (complete response [CR] or partial response [PR]) (time frame: Up to 8 years). The study lists 2 primary outcomes in all. 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 17 Mar 2015.