Carfilzomib and Melphalan Before Stem Cell Transplant in Treating Patients With Multiple Myeloma
CompletedPhase 1, PHASE2Results postedLast updated 1 September 2020
What this trial tests
Phase 1, PHASE2 trial testing Autologous Bone Marrow Transplantation in DS Stage I Plasma Cell Myeloma in 50 participants. Completed in 28 October 2019.
18 and older, any sex, with DS Stage I Plasma Cell Myeloma or DS Stage II Plasma Cell 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.
Determine Maximum Tolerated Dose by the Number of Patients With a DLT Per Dose LevelPrimary· Up to day 30
Will be defined as the dose level below the lowest dose that induces dose-limiting toxicity(DLT) in at least one-third of patients. For this study, a DLT is any of the following during the first 2 cycles of treatment; Absolute neutrophil count engraftment\* delayed beyond day 21 or Platelet engraftment\* delayed beyond day 30, grade 3+ related sensory or motor neuropathy, or grade 4+ related non-neurologic or non-hematologic adverse event(excluding nausea, vomiting, and diarrhea. Reported below are the number of patients who experienced a DLT.
Group
Value
95% CI
Phase 1: Dose Level 3
1
Phase 1: Dose Level 2
0
Phase 1: Dose Level 1
0
Phase 1: Dose Level 0
0
Percentage of Patients With Complete Responses, Defined as a Complete Response Noted as the Objective Status on Two Consecutive Evaluations (Phase II)Primary· Up to 5 years
The percentage of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success percentages will be calculated.
Group
Value
95% CI
Dose Level 3
21.95
10.56 – 37.61
Adverse Event Rate, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Secondary· Up to 5 years
These results are reported in the adverse events section. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.
Group
Value
95% CI
Phase 1: Dose Level 3
6
Phase 1: Dose Level 2
3
Phase 1: Dose Level 1
3
Phase 1: Dose Level 0
2
Phase 2: Dose Level 3
35
Complete Response Rate at Day 100Secondary· At day 100
Complete response rate (CRR) is defined as the percentage of complete responses estimated by the total number of patients who achieve a complete response by day 100 post-transplant divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true complete response rate at day 100 will be calculated.
Group
Value
95% CI
Dose Level 3
17.07
7.15 – 32.06
Progression Free Percentage at 1 and 2 Years Post RegistrationSecondary· At 1 year and 2 years
Progression is an Increase of 25% from lowest value in any of the following (A "25% increase" refers to M protein, FLC and bone marrow results and does not refer to bone lesions, soft tissue plasmacytoma or hypercalcemia. The lowest value does not need to be a confirmed value. If the lowest serum Mprotein is ≥ 5 g/dL, an increase in serum M-protein of ≥ 1 g/dL is sufficient to define disease progression.), (In the case where a value is felt to be a spurious result per physician discretion (for example, a possible lab error), that value will not be considered when determining the lowest value.)
1 year
Group
Value
95% CI
Dose Level 3
90.24
76.87 – 97.28
2 years
Group
Value
95% CI
Dose Level 3
75.61
59.70 – 87.64
Adverse events — posted to ClinicalTrials.gov
Time frame: 5 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase I/II trial studies the side effects and best dose of carfilzomib when given together with melphalan and to see how well they work in treating patients with multiple myeloma before stem cell transplant. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving carfilzomib together with melphalan may kill more cancer cells.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Mayo Clinic
Last refreshed: 1 September 2020
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/NCT01842308.