Phase 2
Completed N=3
Bortezomib Based Consolidation in Multiple Myeloma Patients Completing Stem Cell Transplant
Source: ClinicalTrials.gov NCT01706666 ↗Enrolled (actual)
3
Serious AEs
66.7%
Results posted
Jun 2016
Primary outcomePrimary: Proportion of Patients Experiencing a Stringent Complete Response (sCR) After 12 Cycles, 24 Months — 100; 0; 100 percentage of participants
Summary
This randomized phase II trial studies how well giving bortezomib with or without combination chemotherapy works as consolidation therapy in patients with newly diagnosed multiple myeloma who have completed stem cell transplant. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, dexamethasone, and lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving bortezomib is more effective with or without combination chemotherapy in the post transplant setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Experiencing a Stringent Complete Response (sCR) After 12 Cycles, 24 Months |
100; 0; 100 | — |
| SECONDARY Survival Time |
NA; NA; NA | — |
| SECONDARY Progression-free Survival |
NA; 9.2; NA | — |
Eligibility Criteria
Inclusion Criteria
- Creatinine = = 1000/mm^3
- Platelet count >= 75000/mm^3
- Hemoglobin >= 8.0 g/dL
- Total bilirubin = = 0.5 g/dL
- > 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
- Serum immunoglobulin free light chain >= 5 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
- Monoclonal bone marrow plasmacytosis >= 30% (evaluable disease)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- = 2 peripheral neuropathy
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; prior to study entry, any electrocardiogram (ECG) abnormality at screening must be documented by the investigator as not medically relevant
- Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial
- Radiation therapy within 3 weeks before randomization; enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy
- Female patients who are lactating or pregnant
Data sourced from ClinicalTrials.gov (NCT01706666). 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. Informational only — not medical advice.