Stem cell study for older myeloma patients halted early
NCT ID NCT01453088
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at two different high-dose chemotherapy treatments for people aged 65 and older with multiple myeloma, a type of blood cancer. Participants received either the standard chemotherapy (melphalan) or a combination of melphalan and another drug (bortezomib) before a stem cell transplant. The goal was to see which treatment helped patients live longer without the cancer getting worse. The study was stopped early and involved 63 participants.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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63 people
The number who actually took part.
- Started
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Jun 2010
- Finished
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May 2022
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Confirmed diagnosis of multiple myeloma less than 12 months since initiation of systemic therapy * Age ≥60 years at time of transplantation * KPS 70-100% * Recovery from complications of prior therapy Exclusion Criteria: * Diagnosis other than multiple myeloma * Chemotherapy or radiotherapy within 8 days of initiating treatment in this study * Prior dose-intense therapy within 56 days of initiating treatment in this study * Uncontrolled bacterial, viral, fungal or parasitic infections * Uncontrolled CNS metastases * Known amyloid deposition in heart * Organ dysfunction * LVEF \<40% or cardiac failure not responsive to therapy * FVC, FEV1 or DLCO \< 40% of predicted and/or receiving supplementary continuous oxygen * Evidence of hepatic synthetic dysfunction or total bilirubin \> 2x or AST \> 3x ULN * Measured creatinine \< 20ml/min * Sensory peripheral neuropathy grade 4 within 14 days of enrollment * Karnofsky score \< 70% * Life expectancy limited by other co-morbid illnesses
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
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Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, 20057, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas
- Banking blood and bone marrow to decode plasma cell disorders
- Which scan sees hidden myeloma better: PET or MRI?