Phase 3
N=363
Autologous Transplant for Multiple Myeloma
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT00177047 ↗Enrolled (actual)
363
Serious AEs
0.5%
Results posted
Nov 2021
Primary outcome: Primary: Number of Participants Achieving a Complete Response — 51 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Stem Cell Transplant (Procedure); Cyclophosphamide + Mesna (Drug); Melphalan (Drug); Granulocyte-colony stimulating factor (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Masonic Cancer Center, University of Minnesota
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Achieving a Complete Response |
123 | — |
| PRIMARY Number of Participants Achieving a Complete Response |
123 | — |
| PRIMARY Number of Participants Achieving a Complete Response |
123 | — |
| SECONDARY Number of Patients With Extended Disease-free Survival |
164 | — |
| SECONDARY Number of Participants With Overall Survival |
301 | — |
| SECONDARY Number of Participants With Overall Survival |
301 | — |
| SECONDARY Number of Participants With Overall Survival |
301 | — |
| SECONDARY Count of Participants Experiencing Transplant Related Mortality |
3 | — |
| SECONDARY Number of Participants Experiencing Incidence of Relapse |
69 | — |
| SECONDARY Number of Participants With Disease Progression |
34 | — |
| SECONDARY Time to Progression |
159.4 | — |
| SECONDARY Time to Relapse |
182.9 | — |
| SECONDARY Number of Participants With Absolute Neutrophil Recovery |
363 | — |
| SECONDARY Time to Attainment of CR |
4.6 | — |
| SECONDARY Time to Attainment of CR+PR |
4.3 | — |
| SECONDARY Duration of Maintenance Treatment |
— | — |
| SECONDARY Dropout Rate From Maintenance Therapy |
— | — |
| SECONDARY Number of Participants With Toxicities |
68 | — |
| SECONDARY Number of Participants With Infections |
68 | — |
Summary
This is a study of a regimen of melphalan and autologous stem cells for patients with multiple myeloma. We hypothesize that this particular regimen will improve the survival of these patients.
Eligibility Criteria
Inclusion Criteria
- Patients meeting the Durie and Salmon criteria for initial diagnosis of multiple myeloma, requiring therapy and meeting one of the following:
- After initial therapy in either first complete or partial remission or no objective response
- After achieving initial response and later disease progression, patient will be eligible after subsequent therapy upon achievement of either complete or partial response
- Is not eligible or has refused any protocols of higher priority
- 18 - 75 years of age
- Adequate organ function defined as:
- Hematologic: hemoglobin ≥ 8 gm/dl (untransfused), white blood cells (WBC) ≥ 3000/μl, absolute neutrophil count (ANC) ≥ 1500/μl, platelets ≥ 100,000/μl (untransfused)
- Cardiac: no active ischemia, left ventricular ejection fraction > 45% by MUGA scan
- Hepatic: bilirubin 50% predicted and Carbon Monoxide Diffusing Capacity (DLCO) (corrected) > 50% predicted
- Performance status: Karnofsky performance of > 80%.
- Free of active uncontrolled infection at the time of study entry.
- At time of study enrollment > 4 weeks from prior myelosuppressive chemotherapy; and > 6 weeks from prior nitrosoureas.
- Patients must exercise informed voluntary consent and sign a consent form approved by the University of Minnesota IRB: Human Subjects Committee.
Exclusion Criteria
- Patients will be ineligible if they have advanced myeloma refractory and unresponsive to salvage chemotherapy regimens.
- Female patients who are pregnant (positive b-HCG) or breastfeeding will be excluded from study entry. In addition fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment, particularly after thalidomide will also be excluded from study entry.
Data sourced from ClinicalTrials.gov (NCT00177047). 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.