Clinical trial · Interventional
S0417 Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
S0417 A Phase II Study of Bortezomib (Velcade™, PS-341), Thalidomide, and Dexamethasone in Patients With Refractory Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor accrual
Summary
Brief summary (as posted)
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as thalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. It may also stop the growth of cancer by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with thalidomide and dexamethasone may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with thalidomide and dexamethasone works in treating patients with 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 | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- bortezomib with thalidomide and dexamethasone
- description
- bortezomib with thalidomide and dexamethasone
- interventionNames
- Drug: bortezomib
- Drug: dexamethasone
- Drug: thalidomide
Primary outcomes (1)
- measure
- Overall Response Rate Complete Remission (CR), Remission (R), and Partial Remission (PR).
- timeFrame
- 1 year
- description
- Responses are defined as follows: Complete Remission: Absence of bone marrow or blood findings of multiple myeloma. This includes disappearance of all evidence of serum and urine M-proteins on immunofixation electrophoresis studies. Normalization of serum concentrations of normal immunoglobulins is not required for CR. There must also be no evidence of increasing anemia. Bone marrow cellularity must be ≥ 20% with plasma cells ≤ 5%. Remission: A ≥ 75% reduction in the serum M-protein, and if a urine M-protein (Bence-Jones protein) is present, either a ≥ 90% reduction in this protein, or a urine M-protein \< 0.2gm/day. Bone marrow plasma cells must be ≤ 5%. Partial Remission: A ≥ 50% reduction in the serum M-protein, and if present, a ≥ 50% reduction in the urine M-protein (Bence-Jones protein). Bone marrow plasma cells must not be increased from baseline level.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of multiple myeloma (MM)
* Active disease
* Relapsed or refractory disease after ≥ 1 prior therapy for MM, that may have included autologous or allogeneic stem cell transplantation
* Relapse is defined as the occurrence of any of the following during or after prior treatment:
* Myeloma protein level increase by \> 100% from the lowest previously recorded level
* Myeloma protein level increase above the defined response criteria for partial remission
* Reappearance of any myeloma peak that had disappeared during the prior treatment
* Increase in the size and number of lytic bone lesions and/or focal lesions by x-ray, MRI, positron emission tomography, and/or CT scan
* Refractory disease is defined as no response (i.e., not achieving complete remission, remission, or partial remission) to prior therapy
* Measurable disease
* No evidence of POEMS (polyneuropathy, organomegaly, endocrinopathy, presence of M-protein, and skin changes) syndrome
* Must be registered on protocol SWOG-S0334
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-2 (unless due to bone pain)
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count \> 1,000/mm\^3
* Platelet count \> 50,000/mm\^3
Hepatic
* AST or ALT ≤ 3 times upper limit of normal (ULN)
* Bilirubin ≤ 3 times ULN
Renal
* Creatinine clearance \> 30 mL/min
Cardiovascular
* No New York Heart Association class III or IV congestive heart failure
* No myocardial infarction within the past 6 months
* No poorly controlled hypertension
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile female patients must use effective double method contraception for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment (during and for 4 weeks after completion of study treatment for male patients)
* No blood, ova, or sperm donation during study treatment
* No active infection requiring antibiotics
* No neurotoxicity ≥ grade 2
* No diabetes mellitus
* No other serious medical or psychiatric illness that would preclude study treatment
* No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
Chemotherapy
* At least 14 days since prior chemotherapy (28 days for nitrosoureas) and recovered
Endocrine therapy
* Not specified
Radiotherapy
* At least 14 days since prior radiotherapy and recovered
Surgery
* Not specified
Other
* No prior bortezomib alone or combined with thalidomide
* Concurrent participation on protocol SWOG-S0309 allowedReferences
Publications (0)
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