Clinical trial · Interventional
S0204 Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma
A Phase II Trial Of Thalidomide/Dexamethasone Induction Followed By Tandem Melphalan Transplant And Prednisone/Thalidomide Maintenance (A BMT Study)
NCT00040937CI-TRIAL-00025094completedPhase 2Results postedClinicalTrials.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 stop the growth of cancer cells by stopping blood flow to the cancer. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Giving thalidomide before and after peripheral stem cell transplant may be effective in treating newly diagnosed multiple myeloma. PURPOSE: This phase II trial is studying how well giving thalidomide with chemotherapy and peripheral stem cell transplant work in treating patients with newly diagnosed 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 (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| prednisone | Drug | Prednisone | ALIAS |
| sargramostim | Biological | — | UNRESOLVED |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment arm
- description
- thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
- interventionNames
- Biological: filgrastim
- Biological: sargramostim
- Drug: cyclophosphamide
- Drug: dexamethasone
- Drug: melphalan
- Drug: prednisone
- Drug: thalidomide
- Procedure: peripheral blood stem cell transplantation
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 4-7 years
Secondary outcomes (1)
- measure
- Assess Toxicity of Thalidomide/Dexamethasone as a Pre-transplant Induction Regimen.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Newly diagnosed multiple myeloma requiring treatment
* Smoldering myeloma with evidence of progressive disease requiring chemotherapy
* More than 25% increase in M component levels and/or Bence-Jones excretion or symptom development
* Non-secretory patients with at least 30% bone marrow plasmacytosis
* No IgM peaks unless there is evidence of more than 30% bone marrow plasmacytosis or more than 3 lytic lesions
PATIENT CHARACTERISTICS:
Age
* 18 to 65
Performance status
* Zubrod 0-2 OR
* Zubrod 3-4 based solely on bone pain
Life expectancy
* Not specified
Hematopoietic
* No untreated, unresolved symptomatic hyperviscosity
Hepatic
* Hepatitis B negative
Renal
* Creatinine no greater than 3 mg/dL if in renal failure and on dialysis (after hydration and/or correction of hypercalcemia)
Cardiovascular
* No history of chronic cerebrovascular accident
* No myocardial infarction within the past 6 months
* No unstable angina
* No congestive heart failure that is difficult to control
* No uncontrollable hypertension
* No cardiac arrhythmia that is difficult to control
Pulmonary
* No history of chronic obstructive or chronic restrictive pulmonary disease
* No untreated, unresolved pneumonia
* Pulmonary function tests (PFTs) at least 50% of predicted
* DLCO at least 50% of predicted
* Arterial partial pressure of oxygen greater than 70 if unable to complete PFTs due to bone pain or fracture
Other
* HIV negative
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No untreated, unresolved pathologic fractures
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use at least 2 highly effective methods of contraception for 4 weeks before, during, and for at least 4 weeks after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No more than 8 weeks of prior thalidomide therapy
Chemotherapy
* No prior chemotherapy for this disease
Endocrine therapy
* Prior steroid therapy allowed provided treatment duration was no more than 2 weeks
Radiotherapy
* No prior radiotherapy to more than 50% of the pelvis
Surgery
* Not specifiedReferences
Publications (2)
- RESULTHussein MA, Bolejack V, Zonder JA, Durie BG, Jakubowiak AJ, Crowley JJ, Barlogie B. Phase II study of thalidomide plus dexamethasone induction followed by tandem melphalan-based autotransplantation and thalidomide-plus-prednisone maintenance for untreated multiple myeloma: a southwest oncology group trial (S0204). J Clin Oncol. 2009 Jul 20;27(21):3510-7. doi: 10.1200/JCO.2008.19.9240. Epub 2009 Jun 22. PMID 19546405
- RESULTHussein MA, Jakubowiak AJ, Bolejack V, et al.: S0204: melphalan (MEL)-based tandem autotransplants (TAT) for multiple myeloma (MM) with thalidomide/dexamethasone (TD) induction and thalidomide/prednisone (TP) maintenance: a phase II trial of the Southwest Oncology Group. [Abstract] Blood 108 (11): A-3088, 2006.