Phase 2
Completed N=147
S0204 Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma
Source: ClinicalTrials.gov NCT00040937 ↗Enrolled (actual)
147
Serious AEs
2.5%
Results posted
Jul 2013
Primary outcomePrimary: Overall Survival — .64 proportion surviving at 4 years
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
.64 | — |
| SECONDARY Assess Toxicity of Thalidomide/Dexamethasone as a Pre-transplant Induction Regimen. |
2 | — |
Eligibility Criteria
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 specified
Data sourced from ClinicalTrials.gov (NCT00040937). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.