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CompletedNCT00003153Updated Jun 15, 2023

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

A Phase 2 interventional study of therapeutic allogeneic lymphocytes in Multiple Myeloma and Plasma Cell Neoplasm, sponsored by Eastern Cooperative Oncology Group. Completed at 2 sites in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2023-06-15.

Sponsored by Eastern Cooperative Oncology Group · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Jul 1998, registered Nov 1999).
Phase
Phase 2
Study type
Interventional
Enrollment
22
Ages
18 Years to 120 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Multiple Myeloma and Plasma Cell Neoplasm

Keywords

  • refractory multiple myeloma
03

In context

Multiple Myeloma

3,712 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.

This study's planned enrollment of 22 is below the median of 41 across 2,965 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Eastern Cooperative Oncology Group is the lead sponsor of 175 studies on the registry; 7 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Browse Eastern Cooperative Oncology Group studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Enrollment
22 participants (estimated)

Interventions

06

Study locations

2 sites
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • Medical College of Wisconsin Cancer Center
    Milwaukee, Wisconsin 53226-3596, United States
07

References and documents

Publications

  • 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. PubMed 19135946 ↗
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 1998 to primary completion in Feb 2007, 103 months.

Of 412 non-industry phase 2 interventional studies under Multiple Myeloma, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 95. This study's 103 months is above that.

Counting every sponsor, half of 502 studies reached it within 55 months; a quarter within 35 and three quarters within 90.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 1999
First posted
Jan 27, 2003
StartActual
Jul 22, 1998
Primary completionActual
Feb 2007
CompletionActual
May 1, 2009
Last update
Jun 15, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00003153
Lead sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
First posted
Jan 27, 2003
Start date
Jul 22, 1998
Primary completion
Feb 2007
Completion
May 1, 2009
Last update
Jun 15, 2023

Study contacts

Neal Flomenberg, MD
study chair · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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