Trial Outcomes & Findings for High Dose Busulfan and Bortezomib in Treating Patients With High Risk Multiple Myeloma Undergoing Stem Cell Transplant (NCT NCT01534143)

Results Overview

Graded using the Glucksberg scale. Proportions and confidence intervals will be estimated. Estimated using binary proportion estimates as well as competing risk method.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

First 6 months post-transplant

Results posted on

2017-04-05

Participant Flow

Cancer center clinic.

Participant milestones

Participant milestones
Measure	Treatment (Chemotherapy, Enzyme Inhibitor) CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2. GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0. anti-thymocyte globulin : Given IV pharmacological study : Correlative studies fludarabine phosphate : Given IV busulfan : Given IV bortezomib : Given IV allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT tacrolimus : Given IV laboratory biomarker analysis : Correlative studies sirolimus : Given PO
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

High Dose Busulfan and Bortezomib in Treating Patients With High Risk Multiple Myeloma Undergoing Stem Cell Transplant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Chemotherapy, Enzyme Inhibitor) n=1 Participants CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2. GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0. anti-thymocyte globulin : Given IV pharmacological study : Correlative studies fludarabine phosphate : Given IV busulfan : Given IV bortezomib : Given IV allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT tacrolimus : Given IV laboratory biomarker analysis : Correlative studies sirolimus : Given PO
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	46 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: First 6 months post-transplant

Population: Data was not collected, because funding was unavailable to continue study.

Graded using the Glucksberg scale. Proportions and confidence intervals will be estimated. Estimated using binary proportion estimates as well as competing risk method.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: First 6 months post-transplant

Estimated using Kaplan-Meier method.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From the date of transplant to the date of death, assessed up to 6 months post transplant

Based on National Cancer Institute (NCI) CTCAE version 4.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: First 6 months post transplant

Based on NCI CTCAE version 4.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time to the first observation of disease progression/relapse post transplant, assessed up to 2 years post transplant

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years post transplant

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years post transplant

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years post transplant

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years post transplant

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Weekly to day 100

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years post transplant

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the day of transplant to progression, death, or last contact, assessed up to 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 30, 60, 90, and at 6 months after transplant

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Chemotherapy, Enzyme Inhibitor)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Chemotherapy, Enzyme Inhibitor) n=1 participants at risk CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2. GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0. anti-thymocyte globulin : Given IV pharmacological study : Correlative studies fludarabine phosphate : Given IV busulfan : Given IV bortezomib : Given IV allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT tacrolimus : Given IV laboratory biomarker analysis : Correlative studies sirolimus : Given PO
Gastrointestinal disorders Mucositis oral	100.0% 1/1 • Number of events 1
General disorders Fever	100.0% 1/1 • Number of events 2
Infections and infestations Staphylococcus bacteremia	100.0% 1/1 • Number of events 1
Infections and infestations CMV	100.0% 1/1 • Number of events 1
Nervous system disorders Headache	100.0% 1/1 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Zaid Al-Kahdimi, M.D.

Barbara Ann Karmanos Cancer Institute

Phone: (313) 576-8022

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place