search
Back to results

Biological Therapy in Treating Patients With Multiple Myeloma That Has Recurred Following Bone Marrow Transplantation

Primary Purpose

Multiple Myeloma and Plasma Cell Neoplasm

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
therapeutic allogeneic lymphocytes
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring refractory multiple myeloma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center
  • Medical College of Wisconsin Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 14, 2023
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00003153
Brief Title
Biological Therapy in Treating Patients With Multiple Myeloma That Has Recurred Following Bone Marrow Transplantation
Official Title
Phase II Study of Salvage Cellular Immunotherapy for Patients With Persistent or Recurrent Multiple Myeloma After Allogeneic Bone Marrow Transplantation From an HLA-Matched Sibling Donor
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 22, 1998 (Actual)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
May 1, 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Assess the response rate of patients with recurrent multiple myeloma after an allogeneic marrow transplant from a genotypically HLA identical sibling donor treated with donor lymphocyte infusions as salvage therapy . Evaluate the safety and toxicity of this treatment when used as salvage therapy in these patients. OUTLINE: Patients receive initial cell dose of donor lymphocytes (CD3+ cells) IV over 15-30 minutes. Patients with rapidly progressive disease may skip the initial cell dose and proceed directly to dose escalation to receive CD3+ cells at a higher cell dose. Patients who achieve complete response to the initial treatment may receive up to 2 additional courses of escalating doses of CD3+ cells 8-12 weeks apart in the absence of unacceptable toxicity. Patients are evaluated at 4 and 8 weeks after each infusion. Patients with disease progression at 8 weeks are retreated at that time. Patients who achieve partial response or stable disease at 8 weeks are re-evaluated at 12 weeks and may then be retreated. Patients are followed every 2 weeks for 3 months, once a month for 9 months, and then every 2 months thereafter. PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study within 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma and Plasma Cell Neoplasm
Keywords
refractory multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
therapeutic allogeneic lymphocytes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Flomenberg, MD
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Study Chair
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3596
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19135946
Citation
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. Erratum In: Biol Blood Marrow Transplant. 2009 Oct;15(10):1346. Huff, Carol A [added].
Results Reference
background

Learn more about this trial

Biological Therapy in Treating Patients With Multiple Myeloma That Has Recurred Following Bone Marrow Transplantation

We'll reach out to this number within 24 hrs