Phase 2
Completed N=124
Melphalan+Bortezomib as a Conditioning Regimen for Autologous and Allogeneic Stem Cell Transplants in Multiple Myeloma
Source: ClinicalTrials.gov NCT00948922 ↗Enrolled (actual)
124
Serious AEs
36.3%
Results posted
Oct 2018
Primary outcomePrimary: Progression Free Survival (PFS) — 17; 25; 19 Participants
Summary
The purpose of this study is to evaluate the effectiveness of Bortezomib when added to standard chemotherapy medicine(s) for treatment of Multiple Myeloma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
17; 25; 19 | — |
| SECONDARY Overall Survival (OS) Rate |
79.2; 89.2; 97.3 | — |
| SECONDARY Molecular Complete Response (CR) Rates in Patients With Multiple Myeloma |
— | — |
Eligibility Criteria
Inclusion Criteria
Multiple Myeloma Criteria(International Uniform Response Criteria for Multiple Myeloma)
- Patients with responsive disease after any line of induction therapy
- A complete response
- A very good partial response
- A partial response
- Patients greater than or equal to 18 years of age are eligible. There is upper age limit of 60 years for allogeneic transplants.
- Patients must have a histologically confirmed diagnosis.
- All patients should have a life expectancy of at least 12 weeks.
- Patients must have undergone a complete psychosocial evaluation and have been considered capable of compliance.
- Meet the following criteria for allogeneic hematopoietic cell transplant:
- Must have an identified donor match defined as: HLA-A, HLA-B, HLA- C, DRB1 8/8 allele matched sibling, family member, or unrelated donor. [7/8 would go on separate mismatched trials] and be /= Grade 2 peripheral neuropathy within 30 days before enrollment.
- Patient has an absolute neutrophil count of 400 in the 30 days prior to initiation of study therapy; or uncompensated major thyroid or adrenal dysfunction are ineligible.
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of >/= 2(Karnofsky /= 5 years after the treatment for the cancer was completed.
Data sourced from ClinicalTrials.gov (NCT00948922). 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.