Clinical trial · Interventional
S0833, Bortezomib, Thalidomide, Lenalidomide, Combination Chemotherapy, and Autologous Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma
S0833, Modified Total Therapy 3 (TT3) for Newly Diagnosed Patients With Multiple Myeloma (MM): A Phase II SWOG Trial for Patients Aged ≤ 65 Years
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of 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 and lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, cisplatin, doxorubicin hydrochloride, cyclophosphamide, etoposide, and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Combining chemotherapy with autologous stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Giving bortezomib, thalidomide, and combination chemotherapy before and after transplant and lenalidomide after transplant may be an effective treatment for multiple myeloma. PURPOSE: This phase II trial is studying how well giving bortezomib, thalidomide, and lenalidomide together with combination chemotherapy and autologous stem cell transplant works in treating patients with newly diagnosed multiple myeloma.
Conditions
Conditions (2)
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 |
| Plasma Cell Myeloma | Multiple Myeloma | CURATED_BROADER | 0.80 |
Interventions
Interventions (13)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous-autologous tandem hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| bortezomib | Drug | Bortezomib | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| gene expression analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment
- description
- Ind (1cycle): bort 1mg/m2 IV/SQ D1,4,8,11 D1-4: thalid 200mg/d \& dex 20mg/d PO; cisplatin \& dox 10mg/m2/d, cyclophos 400mg/m2/d, etoposide 40mg/m2/d contIV; enoxaparin 40mg/d SQ prn. PBSC Coll: at recovery per local standard Bridging (before/between trans/after Cons): thal 50mg/d D1-21 \& dex 20mg D1,8,15 PO Tandem Trans (x2): bort 1mg/m2 IV/SQ D-4,-1 D-4to-1: mel 50 mg/m2 IV, thal 200mg/d \& dex 40mg/d PO PBSC \>/=200x10\^6 cells Cons (1cycle): same as Ind except cis/dox 7.5mg/m2/d, cyclo 300mg/m2/d, no enox Maint(\</= 3 yrs): D1,8,15,22:bort 1mg/m2 IV/SQ, dex 20mg/d PO; len 20mg/d PO D1-20
- interventionNames
- Drug: bortezomib
- Drug: cisplatin
- Drug: cyclophosphamide
- Drug: dexamethasone
- Drug: doxorubicin hydrochloride
- Drug: etoposide
- Drug: lenalidomide
- Drug: melphalan
- Drug: thalidomide
- Genetic: gene expression analysis
- Genetic: microarray analysis
- Other: laboratory biomarker analysis
- Procedure: autologous-autologous tandem hematopoietic stem cell transplantation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Newly diagnosed active multiple myeloma (MM) * Measurable disease * Non-secretory disease allowed provided patient has ≥ 20% plasmacytosis or multiple (\> 3) focal plasmacytomas on skeletal survey and/or MRI PATIENT CHARACTERISTICS: * Zubrod performance status (PS) 0-2 (Zubrod PS 3-4 allowed if based solely on bone pain) * ANC ≥ 1,500/mm\^3\* * Platelet count ≥ 150,000/mm\^3\* * Serum creatinine clearance of ≥ 60 mL/min * Patients with creatinine clearance of \< 60 mL/min receive a lower dose of melphalan * No patients receiving or planning to receive dialysis * Total bilirubin ≤ 1.5 times upper limit of normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Must be fully aware of the teratogenic potential of thalidomide * Must be willing to comply with the FDA-mandated S.T.E.P.S. program * Ejection fraction \> 40% as measured by MUGA scan or two-dimensional ECHO * No peripheral neuropathy ≥ grade 2 per CTCAE v. 4.0 * No known hypersensitivity to bortezomib, boron, or mannitol * No uncontrolled diabetes defined as fasting glucose level \> 200 mg/dL on at least more than two occasions or more that two serum random blood levels \> 300 mg/dL despite adequate treatment * Patients with a history of diabetes mellitus requiring treatment should be on a stable regimen and have their blood glucose closely monitored * No other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has not received treatment within the past year NOTE: \*Unless myeloma-related marrow infiltration is documented, defined as ≥ 30% marrow cellularity with 50% of the cells being malignant plasma cells. PRIOR CONCURRENT THERAPY: * At least 4 weeks since prior chemotherapy or radiotherapy * No more than 1 prior course of chemotherapy for MM * Prior chemotherapy must not have included melphalan * No prior radiotherapy to large area of the pelvis (more than half of the pelvis) * Prior radiotherapy for symptomatic localized bone lesions or impending cord compression allowed
References
Publications (0)
Data not yet available