Clinical trial · Interventional
Combination Chemo, Peripheral Stem Cell Transplant, Biological Therapy, Pamidronate and Thalidomide for Multiple Myeloma
Sequential High-Dose Melphalan and Busulfan/Cyclophosphamide Followed by Peripheral Blood Progenitor Cell Rescue, Interferon/Thalidomide and Pamidronate for Patients With Multiple Myeloma
NCT00004088CI-TRIAL-00039291completedPhase 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: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. Biological therapies, such as interferon alfa, use different ways to stimulate the immune system and stop cancer cells from growing. Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. Pamidronate may help to reduce the side effects of treatment for multiple myeloma. PURPOSE: This phase II trial is studying combination chemotherapy, peripheral stem cell transplantation, biological therapy, pamidronate, and thalidomide to see how well they work in treating patients with stage I, stage II, or stage III 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 and Plasma Cell Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| busulfan | Drug | Busulfan | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
| pamidronate disodium | Drug | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| recombinant interferon alfa | Biological | — | UNRESOLVED |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HD chemotherapy followed by PBPC Rescue
- description
- Patients receive high-dose (HD) melphalan intra-venously (IV) on day -1. Peripheral blood progenitor cells (PBPCs) are reinfused on day 0. Filgrastim (G-CSF) is administered IV or SC daily beginning on day 1 and continuing until blood counts recover. Between 8 and 14 weeks later, patients receive IV high-dose busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. PBPCs are reinfused on day 0 and G-CSF is administered IV or subcutaneously (SC) daily until blood counts recover.
- interventionNames
- Biological: filgrastim
- Biological: recombinant interferon alfa
- Drug: busulfan
- Drug: cyclophosphamide
- Drug: melphalan
- Drug: pamidronate disodium
- Drug: thalidomide
- Procedure: peripheral blood stem cell transplantation
Primary outcomes (6)
- measure
- Best Response Prior to Tandem Autologous Stem Cell Transplant
- timeFrame
- From enrollment in the study until day -8: before dilantin given pre-first high-dose chemo preceeding first cycle of tandem autologous cell transplant
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically proven stage I-III multiple myeloma
* Less than 18 months since diagnosis
* Smoldering myeloma allowed if there is evidence of progressive disease requiring therapy
* At least 25% increase in M protein levels or Bence Jones excretion
* Hemoglobin no greater than 10.5 g/dL
* Hypercalcemia
* Frequent infections
* Rise in serum creatinine above normal on 2 separate occasions
* Nonquantifiable monoclonal proteins allowed if other criteria for multiple myeloma or smoldering myeloma are met
* Response/status after induction therapy:
* Responding or stable disease AND no greater than 40% myelomatous involvement of bone marrow
* No Waldenstrom's macroglobulinemia
PATIENT CHARACTERISTICS:
Age:
* 65 and under
Performance status:
* Karnofsky 80-100%
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* Serum glutamic axaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) less than 2.5 times upper limit of normal
* Hepatitis B antigen or hepatitis C ribonucleaic acid (RNA) negative
Renal:
* See Disease Characteristics
* Creatinine no greater than 1.4 mg/dL
* Creatinine clearance greater than 65 mL/min
Cardiovascular:
* Cardiac ejection fraction at least 50% by multigated acquisition scan (MUGA) or echocardiogram
Pulmonary:
* Forced-expiratory volume in one second (FEV\_1) greater than 60% of normal
* Diffusing capacity for carbon monoxide (DLCO) greater than 50% of predicted lower limit
Other:
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* Human immunodeficiency virus (HIV) negative
* No other medical or psychosocial problems that would increase patient risk
* No other malignancy within past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
* No known hypersensitivity to filgrastim (G-CSF) or Escherechi coli-derived proteins
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* No more than 3 prior chemotherapy regimens
* At least 4 weeks since prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 4 weeks since prior radiotherapy
Surgery:
* Not specifiedReferences
Publications (1)
- BACKGROUNDLong-term Progression-free (PFS) and Overall Survival (OS) with Tandem Autologous Transplant (TASCT) After High-dose Induction With Melphalan (MEL) and Busulfan/cyclophosphamide (BU/CY), or a Novel Regimen of MEL and Total Marrow Irradiation (TMI), Followed by Maintenance With Interferon A-2 (IF) and/or Thalidomide (THAL). Haematologica 96(s1), 2011, s103. G. Somlo, J. Palmer, A. Dagis, M. O'Donnell, D. Snyder, F. Sahebi, N. Kogut, A. Brown, R. Spielberger, P.Parker, C. Karanes, L. Popplewell, A. Stein, A. Krishnan, J. Alvarnas, J. Wong, S. Forman.