Multiple MyelomaPhase 2NCT00005624
CI-994 in Treating Patients With Advanced Myeloma
A Phase 2 study testing CI-994 in people with Multiple Myeloma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of CI-994 in treating patients who have advanced 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?
- CI-994
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1997to Feb 2003
- 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
DISEASE CHARACTERISTICS: Histologically confirmed stage IIA or IIIA myeloma with a measurable M- component in the serum or urine Progressing disease after conventional chemotherapy
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Greater than 8 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 75,000/mm3 (transfusion independent) Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST/ALT no greater than 2 times ULN Renal: Creatinine no greater than 1.5 times ULN Calcium no greater than 12 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No life threatening illness unrelated to the tumor No concurrent serious infection No prior malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix Must be capable of swallowing intact medication capsules No medical or psychiatric condition that would prevent written informed consent
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 14 days since prior immunologic agents No concurrent immunologic agents Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 2 weeks since prior high dose corticosteroids No concurrent anticancer hormonal therapy No concurrent corticosteroids Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: A Multicenter Phase 2 Study of Oral N-Acetyl Dinaline (CI-994) in the Treatment of Patients With Advanced Myeloma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of CI-994 in treating patients who have advanced myeloma.
Read the detailed description
OBJECTIVES: I. Determine the antitumor activity of CI-994 in patients with advanced myeloma. II. Determine the response rate, response duration, and overall survival of this patient population with this treatment regimen. III. Determine the safety of this treatment in these patients.
OUTLINE: This is a multicenter study. Patients receive CI-994 orally daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed for 30 days and then every 2 months.
PROJECTED ACCRUAL: A total of 8-63 patients will be accrued for this study.
- Conditions
- Multiple Myeloma
- Being tested
- CI-994
- Keywords
- refractory multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, plasma cell neoplasm
- 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.
CI-994Drug
Also called Oral N-Acetyl Dinaline, Tacedinaline, HDAC Inhibitor, CAS 112522-64-2
CI-994 as outlined in treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| CI-994 Treatment | Experimental | Patients receive CI-994 orally daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed for 30 days and then every 2 months. Receives: Drug: CI-994 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Response Rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Measured: 5 years
Secondary outcomes (3)
Duration of Response
Response of duration in months
Measured: 5 years
Number of Participants with Overall Survival (OS)
Participants surviving at end of study.
Measured: 5 years
Number of Participants with Adverse Events
Review of adverse events utilizing Common Toxicity Criteria (CTC) V3.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2004 (estimated)
- Study startAug 1997
- Primary completionFeb 2003
- Study completionFeb 2003
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.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Parke-Davis
- Responsible party
- Sponsor
- Investigators
- Melissa Alsina, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005624
- Sponsor's protocol ID
- MCC-11560
- Other IDs
- PD-994-04, NCI-G00-1758
- Status last verified
- Sep 2012
- First submitted
- 2 May 2000
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase 2 Study of Oral N-Acetyl Dinaline (CI-994) in the Treatment of Patients With Advanced Myeloma
- ClinicalTrials.gov ID
- NCT00005624
- Acronym / sponsor ID
- MCC-11560
- Conditions
- Multiple Myeloma
- Keywords
- refractory multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, plasma cell neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Parke-Davis
- Study start
- Aug 1997
- Primary completion
- Feb 2003 (actual)
- Study completion
- Feb 2003 (actual)
- First posted
- 26 Jul 2004 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of CI-994 in treating patients who have advanced myeloma.
Detailed description
OBJECTIVES: I. Determine the antitumor activity of CI-994 in patients with advanced myeloma. II. Determine the response rate, response duration, and overall survival of this patient population with this treatment regimen. III. Determine the safety of this treatment in these patients.
OUTLINE: This is a multicenter study. Patients receive CI-994 orally daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed for 30 days and then every 2 months.
PROJECTED ACCRUAL: A total of 8-63 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CI-994 Treatment | Experimental | Drug: CI-994Patients receive CI-994 orally daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed for 30 days and then every 2 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| CI-994Also: Oral N-Acetyl Dinaline, Tacedinaline, HDAC Inhibitor, CAS 112522-64-2CI-994 as outlined in treatment arm. | Drug | CI-994 Treatment |
Primary outcome
Overall Response Rate (ORR)
Time frame: 5 years
Response Rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
3 secondary outcomes
Duration of Response
Time frame: 5 years
Number of Participants with Overall Survival (OS)
Time frame: 5 years
Number of Participants with Adverse Events
Time frame: 5 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 25 Sep 2012.
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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.
Melissa Alsina, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
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 CI-994 in people with Multiple Myeloma, run by H. Lee Moffitt Cancer Center and Research Institute 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?
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 25 Sep 2012. 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?
Overall Response Rate (ORR) (time frame: 5 years). 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 25 Sep 2012.