Clinical trial · Interventional
Oblimersen, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
A Phase II Study Of Genasense In Combination With Thalidomide And Dexamethasone In Relapsed And Refractory Multiple Myeloma
NCT00049374CI-TRIAL-00041173completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexamethasone | Drug | Dexamethasone | ALIAS |
| oblimersen sodium | Biological | — | UNRESOLVED |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Complete and partial remission
Secondary outcomes (1)
- measure
- Relationship between molecular and clinical outcomes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 patientsReferences
Publications (1)
- RESULTBadros 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. PMID 15867202