Phase 2
N=36
Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon Alfa in Treating Patients With Advanced Multiple Myeloma
Refractory Multiple Myeloma · Stage I Multiple Myeloma · Stage II Multiple Myeloma · Stage III Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT00006244 ↗Enrolled (actual)
36
Serious AEs
27.8%
Results posted
May 2017
Primary outcome: Primary: Overall Survival — 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- melphalan (Drug); recombinant interferon alfa (Biological); aldesleukin (Biological); in vitro-treated peripheral blood stem cell transplantation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fred Hutchinson Cancer Center
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
9 | — |
| PRIMARY Initial Response to Therapy |
15; 8; 10; 3 | — |
| PRIMARY Time to Disease Progression |
1.61 | — |
| PRIMARY Proportion of Patients Alive and in Remission |
4 | — |
| SECONDARY Number of Patients <56 Years Old Experiencing Grade 3-4 Regimen Related Toxicity |
1 | — |
| SECONDARY Number of Patients ≥56 Years Old Experiencing Grade 3-4 Regimen Related Toxicity |
— | — |
Summary
This phase II trial studies the effectiveness of melphalan, peripheral stem cell transplantation, and interleukin-2 followed by interferon alfa in treating patients who have advanced multiple myeloma (MM). Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Interleukin-2 (IL2) may stimulate a person's white blood cells to kill multiple myeloma cells. Interferon alfa may interfere with the growth of cancer cells
Eligibility Criteria
Inclusion Criteria
- Patient must be less than 70 years old
- Patients with advanced Multiple Myeloma that meet the eligibility requirements for mobilization/debulking with Cytoxan/VP-16/G-CSF, Cytoxan/Taxol/G-CSF, or Cytoxan/G-CSF (according to protocol 506.03); if clinically indicated a lower dose of cytoxan than 4g/m2 may be used for mobilization based on the attending's discretion; also, if the patients had previously collected PBSC of sufficient number in the past and meet the other eligibility requirements, they may be entered on this study after approval by the PI
- Patients with advanced Multiple Myeloma that have an identical syngeneic twin for donation of PBSCs
- Patients have advanced Multiple Myeloma if they were diagnosed initially with stage II or III disease or had stage I disease that progressed after initial therapy or failed to respond to therapy
- Syngeneic Donor Inclusion:
- Donor and patient have adequate documentation that donor and recipient are syngeneic; including ABO typing, HLA typing and VNTR studies
- Donor > 20 kg
- Donor meets eligibility to donate according to Standard Practice Guidelines
Exclusion Criteria
- Patient's age >= 70
- Karnofsky score less than 80
- A left ventricular ejection fraction less than 50%; Patients with congestive heart disease, history of myocardial infarction (MI), coronary artery disease or any arrhythmia history
- Total bilirubin > 1.5 mg/ml (unless history of Gilbert's disease)
- Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) > 2 x upper limit of normal
- Estimated creatinine clearance 2.0 mg/dl
- Pregnancy
- Seropositivity for human immunodeficiency virus
- Patients who cannot give informed consent
- Secondary malignancies other than basal cell carcinoma of the skin or carcinoma in situ within the last five years
- History of seizures or requirement for medicines, such as haldol, for controlling mental disorders
- Concurrent need for corticosteroid therapy
- Active connective tissue disease
- Pleural effusion, pericardial effusion or ascites
- Patients allergic to gentamicin
- Patients with positive PCR for hepatitis C or hepatitis B
- Patients with hypersensitivity to E. coli - derived preparations
- Patients with systemic infection at time of IL2 therapy
- Patients who previously have had more than 50% of their pelvic area irradiated
- Patients with pulmonary function tests that show diffusion capacity (corrected) < 60%, and/or forced expiratory volume in 1 second (FEV1) < 65% of predicted
Data sourced from ClinicalTrials.gov (NCT00006244). 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.