Trial Outcomes & Findings for Bortezomib and Bendamustine to Treat Relapsed/Refractory Myeloma (NCT NCT01315873)

Results Overview

These criteria included measures of alteration in the natural history of disease, hematologic improvement, cytogenetic response, and improvement in health-related quality of life.The IWG criteria define 4 aspects of responses based on treatment goals: (1) altering the natural history of the disease, (2) cytogenetic response, (3) hematologic improvement (HI), and (4)Quality of Life (QOL)

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

8 weeks

Results posted on

2018-02-07

Participant Flow

Participant milestones

Participant milestones
Measure	Bortezomib and Bendamustine Bendamustine: On days 1 and 4 of each cycle, bendamustine is given at 90 mg/m\^2 after bortezomib . Patients will be dose reduced to 75 mg/m\^2, and then to 60 mg/m\^2 bendamustine on days 1 and 4 if ANC is not \>1 x 10\^9/L and platelets are not \>50 x 10\^9/L on day 1 of each cycle. Patients will be treated until disease progression after at least one cycle of treatment. Bortezomib: On days 1 and 4 of each cycle, bortezomib is given first at 1.3 mg/m\^2 followed by bendamustine given at 90 mg/m\^2. Patients will be dose reduced to 75 mg/m\^2, and then to 60 mg/m\^2 bendamustine on days 1 and 4 if ANC is not \>1 x 10\^9/L and platelets are not \>50 x 10\^9/L on day 1 of each cycle. Patients will be treated until disease progression after at least one cycle of treatment.
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bortezomib and Bendamustine to Treat Relapsed/Refractory Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bortezomib and Bendamustine n=24 Participants Bendamustine: On days 1 and 4 of each cycle, bendamustine is given at 90 mg/m\^2 after bortezomib . Patients will be dose reduced to 75 mg/m\^2, and then to 60 mg/m\^2 bendamustine on days 1 and 4 if ANC is not \>1 x 10\^9/L and platelets are not \>50 x 10\^9/L on day 1 of each cycle. Patients will be treated until disease progression after at least one cycle of treatment. Bortezomib: On days 1 and 4 of each cycle, bortezomib is given first at 1.3 mg/m\^2 followed by bendamustine given at 90 mg/m\^2. Patients will be dose reduced to 75 mg/m\^2, and then to 60 mg/m\^2 bendamustine on days 1 and 4 if ANC is not \>1 x 10\^9/L and platelets are not \>50 x 10\^9/L on day 1 of each cycle. Patients will be treated until disease progression after at least one cycle of treatment.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment United States	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Participant data was not analyzed because PI left institution

These criteria included measures of alteration in the natural history of disease, hematologic improvement, cytogenetic response, and improvement in health-related quality of life.The IWG criteria define 4 aspects of responses based on treatment goals: (1) altering the natural history of the disease, (2) cytogenetic response, (3) hematologic improvement (HI), and (4)Quality of Life (QOL)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 4 weeks.

Population: Participant data was not analyzed because PI left institution. Data were not available for analysis.

Study toxicity will be measured on an ongoing basis, no less then once per 28-day cycle.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: from initial response to relapse, up to 100 weeks.

Population: Participant data was not analyzed because PI left institution

Time from response to relapse. Response would have been assessed using European Group for Blood and Marrow Transplantation (EBMT) criteria modified to include near complete remission (nCR) and very good partial remission (VGPR

Outcome measures

Outcome data not reported

Adverse Events

Bortezomib and Bendamustine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Grossbard, MD

New York University School of Medicine

Phone: 646 501 9305

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place