Multiple Myeloma and Plasma Cell NeoplasmPhase 2NCT00049374
Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
A Phase 2 study testing oblimersen sodium, dexamethasone and thalidomide in people with Multiple Myeloma and Plasma Cell Neoplasm, run by University of Maryland, Baltimore at 2 sites in United States.
Trial summary
RATIONALE: Thalidomide may slow the growth of cancer cells. Oblimersen may increase the effectiveness of thalidomide and dexamethasone by making cancer cells more sensitive to the drugs. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Multiple Myeloma and Plasma Cell Neoplasm
- What is being tested?
- oblimersen sodium, dexamethasone and thalidomide
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Sep 2002to Jan 2006
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically and clinically confirmed multiple myeloma
- Relapsed and/or refractory after chemotherapy or transplantation
- Patients with prior allogeneic transplantation must not have evidence of active graft-vs-host disease requiring immune suppression
- Measurable disease defined by quantitative immune globulin levels in serum and/or urine and bone marrow plasmacytosis
- Patients with nonsecretory disease are eligible provided at least 1 plasmacytoma lesion is accurately measurable by MRI or CT scan
- No known CNS involvement
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
- More than 3 months
Hematopoietic
- See Disease Characteristics
- Absolute neutrophil count at least 1,000/mm^3*
- Platelet count at least 50,000/mm^3* NOTE: *Unless secondary to bone marrow plasmacytosis (more than 80% involvement)
Hepatic
- Bilirubin less than 2 times normal
- AST/ALT no greater than 3 times upper limit of normal
Renal
- Creatinine no greater than 2 mg/dL
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other
- Seizures allowed if under adequate control
- No severe skin reactions from prior thalidomide
- No prior allergic reactions attributed to agents used in this study
- No sensory or motor neuropathy grade II or greater
- No other uncontrolled concurrent illness that would preclude study therapy
- No ongoing or active infection
- No psychiatric illness or social situations that would preclude study compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 effective methods of contraception for 1 month before, during, and for 1 month after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- See Chemotherapy
- At least 6 weeks since prior thalidomide
Chemotherapy
- See Disease Characteristics
- No more than 4 prior chemotherapy regimens, including autologous and/or allogeneic stem cell transplantation regimens
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
Endocrine therapy
- Concurrent continuous steroids allowed for chronic treatment of disorders other than myeloma
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No prior oblimersen
- No other concurrent anticancer therapies or investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201-1592
St. Vincent's Comprehensive Cancer Center - Manhattan
New York, New York, 10011
About this study
Official title: A Phase II Study Of Genasense In Combination With Thalidomide And Dexamethasone In Relapsed And Refractory Multiple Myeloma
RATIONALE: Thalidomide may slow the growth of cancer cells. Oblimersen may increase the effectiveness of thalidomide and dexamethasone by making cancer cells more sensitive to the drugs.
PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and dexamethasone with oblimersen in treating patients who have relapsed or refractory multiple myeloma.
Read the detailed description
OBJECTIVES:
- Determine the clinical efficacy of oblimersen, thalidomide, and dexamethasone, in terms of complete and partial response rates, in patients with relapsed or refractory multiple myeloma.
- Determine the time to progression and duration of response in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Correlate disease response (clinical outcome) with changes in Bcl-2 levels in patients treated with this regimen.
- Determine the disease-free and overall survival of patients treated with this regimen.
OUTLINE: Patients receive induction therapy comprising oblimersen IV continuously on days 1-7, 22-28, and 43-49, oral dexamethasone on days 4-7, 25-28, and 46-49, and oral thalidomide daily beginning on day 4. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients with stable disease after induction therapy receive maintenance therapy comprising oblimersen IV continuously on days 1-7, oral dexamethasone on days 4-7, and oral thalidomide daily. Courses repeat every 35 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Patients are followed for 3 years.
PROJECTED ACCRUAL: A total of 10-46 patients will be accrued for this study within 10 months.
- Being tested
- oblimersen sodium, dexamethasone, thalidomide
- Keywords
- refractory multiple myeloma
- 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.
oblimersen sodiumBiological
dexamethasoneDrug
thalidomideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete and partial remission
Secondary outcomes (1)
Relationship between molecular and clinical outcomes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 2002
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Myeloma and Plasma Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Maryland Greenebaum Cancer Center
- Investigators
- Ashraf Z. Badros, MD, Study chair, University of Maryland Greenebaum Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00049374
- Sponsor's protocol ID
- CDR0000258058
- Other IDs
- MSGCC-210421, NCI-5824
- Status last verified
- Oct 2019
- First submitted
- 12 Nov 2002
- Last updated
- 17 Oct 2019
- Results posted
- No
Publications
Badros AZ, Goloubeva O, Rapoport AP, Ratterree B, Gahres N, Meisenberg B, Takebe N, Heyman M, Zwiebel J, Streicher H, Gocke CD, Tomic D, Flaws JA, Zhang B, Fenton RG. Phase II study of G3139, a Bcl-2 antisense oligonucleotide, in combination with dexamethasone and thalidomide in relapsed multiple myeloma patients. J Clin Oncol. 2005 Jun 20;23(18):4089-99. doi: 10.1200/JCO.2005.14.381. Epub 2005 May 2.
PubMed 15867202
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of Genasense In Combination With Thalidomide And Dexamethasone In Relapsed And Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00049374
- Acronym / sponsor ID
- CDR0000258058
- Keywords
- refractory multiple myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Maryland Greenebaum Cancer Center
- Study start
- Sep 2002
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 27 Jan 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.
RATIONALE: Thalidomide may slow the growth of cancer cells. Oblimersen may increase the effectiveness of thalidomide and dexamethasone by making cancer cells more sensitive to the drugs.
PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and dexamethasone with oblimersen in treating patients who have relapsed or refractory multiple myeloma.
Detailed description
OBJECTIVES:
- Determine the clinical efficacy of oblimersen, thalidomide, and dexamethasone, in terms of complete and partial response rates, in patients with relapsed or refractory multiple myeloma.
- Determine the time to progression and duration of response in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Correlate disease response (clinical outcome) with changes in Bcl-2 levels in patients treated with this regimen.
- Determine the disease-free and overall survival of patients treated with this regimen.
OUTLINE: Patients receive induction therapy comprising oblimersen IV continuously on days 1-7, 22-28, and 43-49, oral dexamethasone on days 4-7, 25-28, and 46-49, and oral thalidomide daily beginning on day 4. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients with stable disease after induction therapy receive maintenance therapy comprising oblimersen IV continuously on days 1-7, oral dexamethasone on days 4-7, and oral thalidomide daily. Courses repeat every 35 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Patients are followed for 3 years.
PROJECTED ACCRUAL: A total of 10-46 patients will be accrued for this study within 10 months.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| oblimersen sodium | Biological | – |
| dexamethasone | Drug | – |
| thalidomide | Drug | – |
Primary outcome
Complete and partial remission
1 secondary outcome
Relationship between molecular and clinical outcomes
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 Oct 2019.
- Results publication: PubMed 15867202Badros AZ, Goloubeva O, Rapoport AP, Ratterree B, Gahres N, Meisenberg B, Takebe N, Heyman M, Zwiebel J, Streicher H, Gocke CD, Tomic D, Flaws JA, Zhang B, Fenton RG. Phase II study of G3139, a Bcl-2 antisense oligonucleotide, in combination with dexamethasone and thalidomide in relapsed multiple myeloma patients. J Clin Oncol. 2005 Jun 20;23(18):4089-99. doi: 10.1200/JCO.2005.14.381. Epub 2005 May 2.
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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.
Ashraf Z. Badros, MD study chair
University of Maryland Greenebaum Cancer Center
2 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 oblimersen sodium, dexamethasone and thalidomide in people with Multiple Myeloma and Plasma Cell Neoplasm, run by University of Maryland, Baltimore at 2 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?
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 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Complete and partial remission. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00049374, which also lists 1 linked publication.
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 Oct 2019.