Study Stopped
Lack of Drug Supply
RO4929097 After Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma
Phase II Study of RO4929097 to Eradicate Residual Disease in Patients With Multiple Myeloma Post Single Autologous Stem Cell Transplant
6 other identifiers
interventional
N/A
1 country
1
Brief Summary
This phase II clinical trial is studying how well gamma-secretase/Notch signalling pathway inhibitor RO4929097 (RO4929097) after autologous stem cell transplant works in treating patients with multiple myeloma. Giving chemotherapy, such as melphalan, before autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Before treatment, stem cells are collected from the patient's blood and stored. After chemotherapy, the stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. RO4929097 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving RO4929097 after autologous stem cell transplant may kill more cancer cells.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2010
CompletedFirst Posted
Study publicly available on registry
December 1, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedSeptember 28, 2017
September 1, 2017
1.6 years
November 30, 2010
September 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Overall response rate of gamma-secretase/Notch signalling pathway inhibitor RO4929097 in eradicating residual/persistent disease, defined as conversion from VGPR to CR or sCR
A Simon's 2-stage optimal Phase II design will be used to monitor the study.
Up to 42 days
Secondary Outcomes (2)
Clonogenic myeloma progenitor cells
At baseline, at 100 days post-transplant, and at 6 weeks
Incidence of adverse events and abnormal laboratory variables as assessed according to the NCI-CTCAE version 4.0
Up to 30 days
Study Arms (1)
Treatment (RO4929097 after autologous stem cell transplant)
EXPERIMENTALSTEM CELL TRANSPLANTATION AND CHEMOTHERAPY: Patients undergo standard mobilization and collection of autologous peripheral stem cells (\>= 4.0 x 10\^6 CD34+ cells/kg). Patients then receive high-dose melphalan IV on days -3 and -2 and undergo autologous stem cell transfusion on day 0. Patients with progressive disease, stable disease, partial response, stringent complete response, or complete response are taken off study; patients with residual/persistent disease (VGPR) continue to therapeutic treatment. THERAPEUTIC TREATMENT: Beginning 100-110 days after transplantation, patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions
Undergo in vitro treated autologous peripheral blood stem cell transplant
Given orally
Undergo standard mobilization
Undergo in vitro treated autologous peripheral blood stem cell transplant
Correlative studies
Given IV
Eligibility Criteria
You may qualify if:
- Patients must have a diagnosis of multiple myeloma as defined below with staging based on the International Staging System:
- Multiple myeloma - all three required (Note: these criteria identify stage 1B and stages II and IIIA/B myeloma by Durie/Salmon stage; stage 1A becomes smoldering or indolent myeloma):
- Monoclonal plasma cells in the bone marrow ≥ 10% and/or presence of a biopsy-proven plasmacytoma
- Monoclonal protein present in the serum and/or urine (if no monoclonal protein is detected \[non-secretory disease\], then \>= 30% monoclonal bone marrow plasma cells and/or biopsy-proven plasmacytoma is required)
- Myeloma-related organ dysfunction (1 or more) (a variety of other types of end organ dysfunctions can occasionally occur and lead to a need for therapy; such dysfunction is sufficient to support classification as myeloma if proven to be myeloma related):
- Calcium elevation in the blood (serum calcium \> 10.5 mg/L or upper limit of normal)
- Renal insufficiency (serum creatinine \> 2mg/dL)
- Anemia (hemoglobin \< 10 g/dL or 2 g \< normal)
- Lytic bone lesions or osteoporosis (if a solitary \[biopsy-proven\] plasmacytoma or osteoporosis alone \[without fractures\] are the sole defining criteria, then \> 30% plasma cells are required in the bone marrow)
- Patients must have measurable disease
- Patients with non-secretory multiple myeloma will be eligible only if the baseline serum free light chain level is elevated (\>= 10 mg/dL)
- For therapeutic treatment with RO4929097, patients must have peripheral blood stem cell collection of \>= 4.0 x 10\^6 cells/kg (patient's ideal body weight)
- ECOG performance status =\< 2, Karnofsky \>= 60%
- Estimated life expectancy of at least 12 weeks
- Absolute neutrophil count (ANC) \>= 1,500/mcL
- +39 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Moffitt Cancer Center
Tampa, Florida, 33612, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mecide Gharibo
Rutgers Cancer Institute of New Jersey
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2010
First Posted
December 1, 2010
Study Start
December 1, 2010
Primary Completion
July 1, 2012
Last Updated
September 28, 2017
Record last verified: 2017-09