NCT00003153

Brief Summary

RATIONALE: White blood cells from donors may be able to kill cancer cells in patients with multiple myeloma that has recurred following bone marrow transplantation. PURPOSE: This phase II trial is studying how well giving donor white blood cells works in treating patients with recurrent multiple myeloma who have undergone bone marrow transplantation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 1998

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

July 22, 1998

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

8.5 years

First QC Date

November 1, 1999

Last Update Submit

June 14, 2023

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

refractory multiple myeloma

Interventions

therapeutic allogeneic lymphocytesBIOLOGICAL

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed recurrent or persistent multiple myeloma at least 6 months following allogeneic bone marrow transplantation (BMT) from an HLA identical sibling * Must meet one of following criteria to be considered persistent, recurrent, or progressive disease: * Residual detectable disease 6-12 months after BMT, as determined by the M protein level or bone marrow involvement, without further evidence of clinical or laboratory improvement on 2 consecutive measurements 4 weeks apart * Complete response not achieved 12 or more months after BMT and there is no evidence of progressive improvement * At least 25% increase of serum paraprotein (greater than 1.0 g/dL) as measured on two occasions or a 50% increase in urinary light chain excretion (greater than 150 mg/day) as measured on 2 occasions * A 10% increase in plasma cells in the bone marrow * Disease in complete response but with recurrence of M protein and 10% point increase in myeloma cells in the marrow allowed * No lytic lesions alone or new soft tissue plasmacytoma as sole evidence of progression PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * More than 4 weeks Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 2.0 times upper limit of normal Renal: * Not specified Other: * No active infection * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Must have received prior allogeneic bone marrow transplantation from an HLA A;B;DR genotypically matched sibling donor * No concurrent interferon therapy for relapsed disease Chemotherapy: * At least 4 weeks since cyclosporine, methotrexate, azathioprine, or other graft versus host disease (GVHD) prophylaxis/treatment without evidence of flare of GVHD * At least 4 weeks since prior chemotherapy for relapsed disease Endocrine therapy: * Must be receiving a dose no greater than 0.25 mg/kg prednisone for at least 4 weeks prior to registration without flare of GVHD * No prior prednisone dose greater than 0.25 mg/kg in the past 4 weeks * Must receive concurrent prednisone of a dose no greater than 0.25 mg/kg * Concurrent corticosteroids allowed Radiotherapy: * Concurrent palliative radiotherapy allowed if evidence of other evaluable disease other than irradiated bony sites Surgery: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226-3596, United States

Location

Related Publications (1)

  • Vesole DH, Zhang L, Flomenberg N, Greipp PR, Lazarus HM, Huff CA; ECOG Myeloma and BMT Committees. A Phase II trial of autologous stem cell transplantation followed by mini-allogeneic stem cell transplantation for the treatment of multiple myeloma: an analysis of Eastern Cooperative Oncology Group ECOG E4A98 and E1A97. Biol Blood Marrow Transplant. 2009 Jan;15(1):83-91. doi: 10.1016/j.bbmt.2008.10.030.

    PMID: 19135946BACKGROUND

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Neal Flomenberg, MD

    Sidney Kimmel Cancer Center at Thomas Jefferson University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NETWORK

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

July 22, 1998

Primary Completion

February 1, 2007

Study Completion

May 1, 2009

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations

US(2)