Recruiting
Phase 1
Phase 2

Doxorubicin, Melphalan, Bortezomib

Sponsor:

Herbert Irving Comprehensive Cancer Center

Code:

NCT00334932

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

bortezomib

melphalan

pegylated liposomal doxorubicin hydrochloride

Study Details

Brief summary:

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving doxorubicin hydrochloride liposome and melphalan together with bortezomib may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of doxorubicin hydrochloride liposome , melphalan, and bortezomib and to see how well they work in treating patients with relapsed or refractory stage I, stage II, or stage III multiple myeloma.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Study ID

NCT00334932

Start date

Feb, 2006

Status verified date

Aug, 2008

Primary completion date

Jan, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

DISEASE CHARACTERISTICS:

  • Diagnosis of multiple myeloma

  • Stage I, II, or III disease according to Durie-Salmon staging criteria
  • Progressive disease, defined as one of the following:

  • For secretory disease:

  • A 25% increase in serum M-protein or Bence Jones protein (an absolute increase of 0.5 g/dL serum M-protein or ≥ 200 mg/24 hours of urine light chain excretion)
  • For nonsecretory disease:

  • Bone marrow biopsy with > 25% increase in plasma cells or an absolute increase of ≥ 10% over prior known level
  • Development of new or worsening existing lytic bone lesions or soft tissue plasmacytomas
  • Hypercalcemia (i.e., calcium > 11.5 mg/dL)
  • Relapsed after complete response
  • Must have received ≥ 2 of the following therapeutic regimens for multiple myeloma:

  • Nonmyeloablative transplantation

  • No significant graft-versus-host disease
  • At least 30 days since prior immunosuppressive therapy (concurrent prednisone allowed provided dose is ≤ 10 mg daily)
  • Mobilization with chemotherapy followed by either single or tandem autologous stem cell transplantation (considered 1 prior regimen)
  • Mobilization with chemotherapy followed by autologous and subsequent nonmyeloablative allogeneic stem cell transplantation (considered 1 prior regimen)
  • Any combination of drugs given concurrently (considered 1 prior regimen)

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • Absolute neutrophil count > 1,000/mm\^3 (no colony-stimulating factors)
  • Platelet count > 50,000/mm\^3 (no transfusion support)
  • Bilirubin ≤ 2.0 mg/dL
  • AST ≤ 4 times upper limit of normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment
  • No history of allergic reaction to compounds containing boron or mannitol
  • No active uncontrolled viral (including HIV), bacterial, or fungal infection
  • No motor or sensory neuropathy ≥ grade 2
  • No myocardial infarction within the past 6 months
  • No New York Heart Association class III or IV heart failure
  • No uncontrolled angina
  • No severe uncontrolled arrhythmia
  • No acute ischemia by EKG
  • LVEF ≥ 35% by MUGA (MUGA required in patients whose lifetime cumulative doxorubicin hydrochloride dose > 400 mg/m\^2)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No grade III or IV toxicity due to previous antineoplastic therapy (except alopecia)
  • At least 3 weeks since prior chemotherapy
  • No prior doxorubicin HCl liposome, melphalan, and bortezomib as combination therapy (single or two-drug combinations of these are allowed)
  • No concurrent corticosteroids (≤ 10 mg prednisone/day or equivalent allowed)
  • No other concurrent chemotherapy
  • No concurrent thalidomide
  • No other concurrent investigational therapy
  • No other concurrent antineoplastic treatment for multiple myeloma, including clarithromycin
  • No concurrent radiation therapy
  • No concurrent nonsteroidal anti-inflammatory agents

Study Design

Enrollment

32 participants

Anticipated

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

bortezomib

melphalan

pegylated liposomal doxorubicin hydrochloride

Primary outcome measure

  • Proportion of patients experiencing treatment-related ≥ grade 3 hematologic or nonhematologic toxicity or treatment-related death (phase I) [ Time Frame: undefined ]

Central Contacts and Locations

Locations

UCSF Helen Diller Family Comprehensive Cancer Center

Recruiting

San Francisco, California, United States, 94115

Contacts

Clinical Trials Office - UCSF Helen Diller Family Comprehensi

877-827-3222

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Clinical Trials Office - Herbert Irving Comprehensive Cancer C

212-305-8615

More Information

Sponsor

Herbert Irving Comprehensive Cancer Center

Last update posted

Jan 10, 2014

Last verified

Aug, 2008

Keywords

  • refractory multiple myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Herbert Irving Comprehensive Cancer Center on 2014-01-10.