Status:
UNKNOWN
High-Dose Melphalan and a Second Stem Cell Transplant or Low-Dose Cyclophosphamide in Treating Patients With Relapsed Multiple Myeloma After Chemotherapy
Lead Sponsor:
Leeds Cancer Centre at St. James's University Hospital
Conditions:
Multiple Myeloma and Plasma Cell Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Giving chemotherapy and bortezomib before a peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factor...
Detailed Description
OBJECTIVES: Primary * To determine the effect on freedom from disease progression in patients with relapsed multiple myeloma treated with re-induction therapy comprising bortezomib, doxorubicin hydr...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of relapsed multiple myeloma
- Symptomatic disease, including non-secretory
- Previously treated with standard chemotherapy and autologous stem cell transplantation
- Requires therapy for first progressive disease AND at least 18 months since first stem cell transplantation
- Patients who were previously immunofixation-negative and are now immunofixation-positive must have \> 5 g/L absolute increase in paraprotein
- Registered in the Myeloma X Relapse (Intensive) Trial and received 2-4 courses of PAD re-induction chemotherapy according to the protocol (consolidation phase)
- Adequate stem cell mobilization available for transplantation defined as ≥ 2x10\^6 CD34 + cells/kg or ≥ 2x10\^8 PBMC/kg including cells stored from a previous harvest (consolidation phase)
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- ANC ≥ 1 x 10\^9/L
- Platelet count ≥ 50 x 10\^9/L
- Creatinine clearance ≥ 30 mL/min
- Total bilirubin \< 2 times upper limit of normal (ULN)
- ALT or AST \< 2.5 times ULN
- History of pulmonary disease allowed provided carbon monoxide diffusion in the lungs (KCO/DLCO) is ≥ 50% and/or no requirement for supplementary continuous oxygen
- Left ventricular ejection fraction ≥ 40% by ECG or MUGA scan
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- No peripheral neuropathy ≥ grade 2
- No known HIV or Hepatitis B or C positivity (testing is not required)
- No known resistance to combined bortezomib, doxorubicin hydrochloride, and dexamethasone therapy
- No known history of allergy to compounds containing boron or mannitol
- No other previous or concurrent malignancies except for appropriately treated localized epithelial skin cancer or carcinoma in situ of the cervix, or remote histories of other cured tumors within the past 5 years
- No medical or psychiatric condition which, in the opinion of the investigator, contraindicates the patient's participation in the study
- No other contra-indication to treatment that would make the patient ineligible for consolidation phase
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No other prior therapy for relapsed disease except for local radiotherapy, therapeutic plasma exchange, or ≤ 200 mg of dexamethasone
- Radiotherapy since prior transplantation sufficient to alleviate or control pain of local invasion is permitted
- No hemi-body radiation since prior transplantation (consolidation phase)
- At least 4 weeks since prior and no concurrent investigational drugs
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT00747877
Start Date
April 1 2008
Last Update
August 12 2013
Active Locations (53)
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1
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom, RG24 9NA
2
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom, B15 2TH
3
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom, B9 5SS
4
Royal Bournemouth Hospital
Bournemouth, England, United Kingdom, BH7 7DW