Phase 2
N=75
High-Dose Gemcitabine, Busulfan and Melphalan With Hematopoietic-Cell Support for Patients With Poor-Risk Myeloma
Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT01237951 ↗Enrolled (actual)
75
Serious AEs
41.9%
Results posted
May 2020
Primary outcome: Primary: Participants Who Had Measurable Disease at Time of Transplant and Achieved a Stringent Complete Remission — 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Palifermin (Drug); Dexamethasone (Drug); Gemcitabine (Drug); Busulfan (Drug); Melphalan (Drug); Stem Cell Transplant (Procedure); G-CSF (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Who Had Measurable Disease at Time of Transplant and Achieved a Stringent Complete Remission |
16 | — |
| SECONDARY Progression-free Survival (PFS) |
31 | — |
| SECONDARY Overall Survival |
49 | — |
| SECONDARY Percent of Participants Dying From Treatment-Related Complications |
4 | — |
Summary
The goal of this clinical research study is to learn if the combination of gemcitabine, busulfan, and melphalan, when given before a stem cell transplant, can help to control refractory myeloma. The safety of this study treatment will also be studied.
Eligibility Criteria
Inclusion Criteria
- Age 18 to 70 years.
- Patients with myeloma treated with first-line therapy including lenalidomide, bortezomib or thalidomide, and one or more of the following: 2.1) M paraprotein greater than 1 g/dL at HDC. 2.2) Less than partial response to first-line therapy. 2.3) Relapse after first-line therapy. 2.4) Relapse after a prior autologous stem-cell transplant.
- Adequate renal function, as defined by serum creatinine /=50 ml/min
- Adequate hepatic function, as defined by serum glutamate oxaloacetate transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) /=50% of expected corrected for hemoglobin and/or volume.
- Adequate cardiac function with left ventricular ejection fraction >/=40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- Zubrod performance status /= 3 non-hematologic toxicity from previous therapy that has not resolved to /=10,000 copies/mL, or >/= 2,000 IU/mL).
- Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.
- Active infection requiring parenteral antibiotics.
- HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal cluster of differentiation 4 (CD4) counts
- Patients having received radiation therapy to head and neck (excluding eyes), and internal organs of chest, abdomen or pelvis in the month prior to enrollment.
Data sourced from ClinicalTrials.gov (NCT01237951). 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.