Vismodegib After Stem Cell Transplant in Treating Patients With High-Risk First Remission or Relapsed Multiple Myeloma
A Phase 1b Study of GDC-0449 Following Autologous Transplantation in Patients With High Risk First Remission or Relapsed Multiple Myeloma
10 other identifiers
interventional
50
1 country
2
Brief Summary
This phase I trial studies how well vismodegib after stem cell transplant works in treating patients with high-risk first remission or relapsed multiple myeloma. Vismodegib may slow the growth of cancer cells. Giving vismodegib after autologous stem cell transplant may kill more multiple myeloma cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2010
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 5, 2011
CompletedFirst Posted
Study publicly available on registry
April 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedDecember 23, 2014
September 1, 2014
3.8 years
April 5, 2011
December 19, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change in MM CSC counts
Estimated using a simple linear regression model. The proportion of patients with negative slope estimates, indicating decline in MM CSC counts over study evaluations will be estimated.
Baseline to 6 months
Secondary Outcomes (3)
Pharmacokinetics of vismodegib
Days 1 and 15
Pharmacodynamics of vismodegib
Up to 4 weeks after completion of study treatment
Time to progression
From treatment initiation to the date of progression, assessed up to 4 weeks after completion of study treatment
Study Arms (1)
Treatment (vismodegib)
EXPERIMENTALPatients receive vismodegib PO QD on days 1-28. Treatment repeats every 28 days for up to 11 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Given PO
Correlative studies
Eligibility Criteria
You may qualify if:
- Patients must have histologically or cytologically confirmed multiple myeloma meeting criteria with symptomatic disease requiring treatment; patients considered to have high risk disease (defined as chromosome 13 deletion by cytogenetics; t(4;14), t(14;16) or 17p deletion by fluorescence in situ hybridization \[FISH\], B2-M \> 5.5 g/dL, immunoglobulin A \[IgA\] phenotype) in first remission (\>= partial remission \[PR\]) or patients with relapsed myeloma responding to salvage therapy (\>= PR) based on the International Uniform Response Criteria are eligible
- Patients must have measurable disease utilizing serum or urine protein electrophoresis or serum kappa / lambda light chain assay
- Patients must be planning to proceed to single autologous transplantation according to institutional standards and must receive this transplantation prior to implementation of GDC-0449
- Concomitant bisphosphonate use is allowed as clinically indicated
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
- Life expectancy of greater than 6 months
- Women of child-bearing potential and men must use two forms of contraception (i.e., barrier contraception and one other method of contraception) at least 4 weeks prior to GDC-0449 treatment, for the duration of study participation, and for at least 12 months post-treatment; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Women of childbearing potential are required to have a negative serum pregnancy test (with a sensitivity of at least 25 mIU/mL) within 10-14 days and within 24 hours prior to the first dose of GDC-0449 (serum or urine); a pregnancy test (serum or urine) will be administered every 4 weeks if their menstrual cycles are regular or every 2 weeks if their cycles are irregular while on study within the 24-hour period prior to the administration of GDC-0449; a positive urine test must be confirmed by a serum pregnancy test; prior to dispensing GDC-0449, the investigator must confirm and document the patient's use of two contraceptive methods, dates of negative pregnancy test, and confirm the patient understands of GDC-0449 cause serious or life-threatening birth defects
- Women of childbearing potential are defined as follows:
- Patients with regular menses
- Patients with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding
- Women who have had a tubal ligation
- Women are considered not to be of childbearing potential for the following reasons:
- The patient has undergone hysterectomy and/or bilateral oophorectomy
- The patient is post-menopausal defined by amenorrhea for at least 1 year in a women
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
Baltimore, Maryland, 21231, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carol Huff
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2011
First Posted
April 6, 2011
Study Start
December 1, 2010
Primary Completion
October 1, 2014
Study Completion
November 1, 2014
Last Updated
December 23, 2014
Record last verified: 2014-09