Trial Outcomes & Findings for Bendamustine Hydrochloride, Etoposide, Dexamethasone, and Filgrastim For Peripheral Blood Stem Cell Mobilization in Treating Patients With Refractory or Recurrent Lymphoma or Multiple Myeloma (NCT NCT01110135)

Last Updated: 2017-05-24

Results Overview

Count of participants with successful mobilization and collection of PBSCs. Defined as collection of \> 2 x 10\^6 CD34/kg. The current study will be deemed to be potentially efficacious if the observed rate of success is at least 80%.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

Within 7 days of apheresis and within 6 weeks of receiving bendamustine hydrochloride

Results posted on

2017-05-24

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Chemotherapy and Colony-stimulating Factor) Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until \> 5 x 10\^6 CD34+/kg has been collected. . bendamustine hydrochloride: Given IV dexamethasone: Given PO filgrastim: Given SC leukapheresis: Given IV laboratory biomarker analysis: Correlative studies flow cytometry: Correlative studies etoposide: Given IV
Overall Study STARTED	43
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bendamustine Hydrochloride, Etoposide, Dexamethasone, and Filgrastim For Peripheral Blood Stem Cell Mobilization in Treating Patients With Refractory or Recurrent Lymphoma or Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Chemotherapy and Colony-stimulating Factor) n=34 Participants Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until \> 5 x 10\^6 CD34+/kg has been collected. . bendamustine hydrochloride: Given IV dexamethasone: Given PO filgrastim: Given SC leukapheresis: Given IV laboratory biomarker analysis: Correlative studies flow cytometry: Correlative studies etoposide: Given IV
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 7 days of apheresis and within 6 weeks of receiving bendamustine hydrochloride

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy and Colony-stimulating Factor) n=34 Participants Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until \> 5 x 10\^6 CD34+/kg has been collected. . bendamustine hydrochloride: Given IV dexamethasone: Given PO filgrastim: Given SC leukapheresis: Given IV laboratory biomarker analysis: Correlative studies flow cytometry: Correlative studies etoposide: Given IV
Successful Mobilization and Collection of PBSCs	34 Participants

Adverse Events

Treatment (Chemotherapy and Colony-stimulating Factor)

Serious events: 6 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Chemotherapy and Colony-stimulating Factor) n=34 participants at risk Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until \> 5 x 10\^6 CD34+/kg has been collected. . bendamustine hydrochloride: Given IV dexamethasone: Given PO filgrastim: Given SC leukapheresis: Given IV laboratory biomarker analysis: Correlative studies flow cytometry: Correlative studies etoposide: Given IV
Vascular disorders Hypotension	5.9% 2/34
Nervous system disorders Stroke	2.9% 1/34
Renal and urinary disorders Renal insufficiency	2.9% 1/34
Cardiac disorders Atrial fibrillation	2.9% 1/34
Blood and lymphatic system disorders Neutropenic fever	2.9% 1/34
Infections and infestations Sepsis	2.9% 1/34

Other adverse events

Other adverse events
Measure	Treatment (Chemotherapy and Colony-stimulating Factor) n=34 participants at risk Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until \> 5 x 10\^6 CD34+/kg has been collected. . bendamustine hydrochloride: Given IV dexamethasone: Given PO filgrastim: Given SC leukapheresis: Given IV laboratory biomarker analysis: Correlative studies flow cytometry: Correlative studies etoposide: Given IV
Blood and lymphatic system disorders Lymphopenia	100.0% 34/34
Blood and lymphatic system disorders Thrombocytopenia	91.2% 31/34
Blood and lymphatic system disorders Neutropenia	97.1% 33/34
Blood and lymphatic system disorders Leukopenia	76.5% 26/34
Metabolism and nutrition disorders Hypophosphatemia	17.6% 6/34
Metabolism and nutrition disorders Hyperglycemia	5.9% 2/34
Musculoskeletal and connective tissue disorders Muscle weakness	5.9% 2/34
Vascular disorders Hypotension	5.9% 2/34

Additional Information

Ajay Gopal

Fred Hutchinson Cancer Research Center

Phone: 206-288-2037

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place