Adults 18 to 75, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Achieving a Complete ResponsePrimary· 100 Days post transplant
Myeloma Response Definitions - Using International Uniform Response Criteria:
Stringent Complete Response (sCR)requires, plus CR:
* Normal free light chain ratio
* Absence of clonal cells in bone marrow
Complete Response (CR):
* Absence of the original monoclonal paraprotein
* \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy
* No increase in size or number of lytic bone lesions
* Disappearance of soft tissue plasmacytomas.
Group
Value
95% CI
Chemotherapy and Transplant Treatment
51
Number of Participants Achieving a Complete ResponsePrimary· 6 months post transplant
Myeloma Response Definitions - Using International Uniform Response Criteria:
Stringent Complete Response (sCR)requires, plus CR:
* Normal free light chain ratio
* Absence of clonal cells in bone marrow
Complete Response (CR):
* Absence of the original monoclonal paraprotein
* \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy
* No increase in size or number of lytic bone lesions
* Disappearance of soft tissue plasmacytomas.
Group
Value
95% CI
Chemotherapy and Transplant Treatment
99
Number of Participants Achieving a Complete ResponsePrimary· 12 months post transplant
Myeloma Response Definitions - Using International Uniform Response Criteria:
Stringent Complete Response (sCR)requires, plus CR:
* Normal free light chain ratio
* Absence of clonal cells in bone marrow
Complete Response (CR):
* Absence of the original monoclonal paraprotein
* \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy
* No increase in size or number of lytic bone lesions
* Disappearance of soft tissue plasmacytomas.
Group
Value
95% CI
Chemotherapy and Transplant Treatment
123
Number of Patients With Extended Disease-free SurvivalSecondary· 36 Months
Extended disease free survival will be defined as percentage of patients surviving more than 36 months without relapse or disease progression.
Group
Value
95% CI
Chemotherapy and Transplant Treatment
164
Number of Participants With Overall SurvivalSecondary· 1 year
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.
Group
Value
95% CI
Chemotherapy and Transplant Treatment
349
Number of Participants With Overall SurvivalSecondary· 2 years
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.
Group
Value
95% CI
Chemotherapy and Transplant Treatment
328
Number of Participants With Overall SurvivalSecondary· 3 years
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.
Group
Value
95% CI
Chemotherapy and Transplant Treatment
301
Count of Participants Experiencing Transplant Related MortalitySecondary· 1 year
In the field of transplantation, toxicity is high and all deaths without previous relapse or progression are usually considered as related to transplantation.
Group
Value
95% CI
Chemotherapy and Transplant Treatment
3
Number of Participants Experiencing Incidence of RelapseSecondary· 1 year
The return of disease after its apparent recovery/cessation.
Group
Value
95% CI
Chemotherapy and Transplant Treatment
69
Number of Participants With Disease ProgressionSecondary· 1 year
Myeloma Response Definitions - Using International Uniform Response Criteria:
Progressive Disease (PD)
For patients not in CR or sCR, progressive disease requires one or more of the following:
* \>25% increase in the level of the serum monoclonal paraprotein, which must also be an absolute increase of at least 0.5 g/dL.
* \>25% increase in 24-hour urine protein electrophoresis, which must also be an absolute increase of at least 200 mg/24 hours.
* Absolute increase in the difference between involved and uninvolved FLC levels (absolute increase must be \>10 mg/dl), only in patients without m
Group
Value
95% CI
Chemotherapy and Transplant Treatment
34
Time to ProgressionSecondary· 1 year
Mean number of days among patients progressing
Group
Value
95% CI
Chemotherapy and Transplant Treatment
159.4
± 109.8
Time to RelapseSecondary· 1 year
Mean number of days among patients relapsing
Group
Value
95% CI
Chemotherapy and Transplant Treatment
182.9
± 113.5
Adverse events — posted to ClinicalTrials.gov
Time frame: 3 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT02589145 — Lenalidomide Combined With Vorinostat/Gemcitabine/Busulfan/Melphalan With Autologous Stem-Cell Transplantation in Diffus
· Phase 1, PHASE2
· terminated
NCT02162420 — Hematopoietic Stem Cell Transplant for Dyskeratosis Congenita or Severe Aplastic Anemia
· NA
· completed
NCT02098109 — Non-inferiority Study of XM02 Filgrastim (Granix) and Filgrastim (Neupogen) in Combination With Plerixafor for Autologou
· Phase 2
· completed
NCT00968760 — CD19-specific T Cell Infusion in Patients With B-Lineage Lymphoid Malignancies
· Phase 1
· completed
Other recruiting trials for Multiple Myeloma
Currently open trials in the same condition.
NCT07200102 — Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma
· Phase 1
· recruiting
NCT07340853 — CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma
· Phase 1
· recruiting
NCT07454382 — A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma
· Phase 2
· recruiting
NCT07266441 — A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma
· Phase 2
· recruiting
NCT07258511 — A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With
· Phase 3
· recruiting
Other Masonic Cancer Center, University of Minnesota trials
Trials by the same sponsor.
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· NA
· not yet recruiting
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· not yet recruiting
NCT07153016 — LEgal Guidance and AdvocaCY for CAREgivers (LEGACY CARE): A Pilot Clinical Trial for Caregivers of Persons With Colorect
· NA
· recruiting
NCT06792825 — HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL
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· recruiting
NCT07070726 — UNTOLD Ovarian Cancer Unmet Needs Survey
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Masonic Cancer Center, University of Minnesota
Last refreshed: 9 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00177047.