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Multiple MyelomaPhase 1/2NCT00421525

Phase I/II Study of hLL1 in Multiple Myeloma

A Phase 1/2 study testing milatuzumab in people with Multiple Myeloma and Myeloma, Plasma-Cell, run by Gilead Sciences at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase I/II, open-label, multi-center study conducted in patients with recurrent or refractory multiple myeloma who have failed at least two prior standard systemic treatments. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
milatuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
6 sitesUnited States
Study dates
Jan 2007to Jun 2009
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to provide signed, informed consent;
  • Male or female, >/=18 years old;
  • Meets clinical trial criteria for a diagnosis of multiple myeloma (Appendix 1)
  • Stage II or III at study entry by Durie-Salmon staging, with either renal function subclassification (A or B) allowed (Appendix 2).
  • Secretory multiple myeloma one or more criteria for measurable disease (serum M protein >1.0 gm/dl measured by serum protein electrophoresis, serum free light chain measurement >200 mg/dl, urinary M protein excretion >200 mg/24 hours);
  • Refractory or relapsed to at least two prior standard systemic anti-myeloma treatment regimens;
Show all 13Show fewer
  • Adequate performance status (Karnofsky Scale >/= 60%);
  • Life expectancy at least 6 months;
  • Adequate hematologic status within 2 weeks before study drug administration:
  • Hemoglobin >8.0 g/dL and platelets > 50,000/mm3 (both without transfusion or other hematologic support within 7 days of laboratory testing)
  • White blood count (WBC) > 2,000/mm3and absolute neutrophil count (ANC) >1,000/mm3 (both without the use of colony stimulating factors within 7 days of laboratory testing)
  • Adequate renal function: serum creatinine < 1.5 x the upper limit of normal (ULN);
  • Adequate hepatic function AST or ALT < 2.5 x the ULN; Total bilirubin < 1.5 x the ULN

Who cannot join

  • Pregnant or lactating women.
  • Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control while enrolled in the study until at least 12 weeks after the last hLL1 infusion;
  • Prior chemotherapy, immunotherapy, radiotherapy, plasmapheresis, kyphoplasty, or major surgery within 4 weeks; prior stem cell transplant within 12 weeks; prior treatment with rituximab within 6 months. Must have recovered from all toxicity from prior treatments;
  • Prior therapy with other murine, chimeric, human or humanized monoclonal antibodies, unless HAHA tested and negative;
  • Prior treatment with any investigational agents within 3 months, unless completed follow-up, off study, and agreed by Sponsor;
  • Prior malignancy within 5 years, excluding multiple myeloma, non-melanoma skins cancers and cervical carcinoma in situ;
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  • Known to be HIV positive, or hepatitis B or C positive;
  • Known autoimmune disease or presence of autoimmune phenomena;
  • Systemic infection or requiring anti-infectives within 7 days before first dose of study drug;
  • Substance abuse or other concurrent medical conditions that, in the investigator's opinion, could confound study interpretation or affect the patient's ability to tolerate or complete the study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Center for Cancer Care

    Goshen, Indiana, 46526

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • New York Presbyterian Hospital/Cornell Medical Center

    New York, New York, 10021

  • Hospital University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Phase I/II Study of Immunotherapy With hLL1 Administered Twice Weekly for 4 Consecutive Weeks in Patients With Multiple Myeloma

This is a Phase I/II, open-label, multi-center study conducted in patients with recurrent or refractory multiple myeloma who have failed at least two prior standard systemic treatments.

Read the detailed description

All patients receive hLL1 administered intravenously twice weekly for 4 consecutive weeks. Cohorts of 3-6 patients will receive escalating doses of hLL1 in order to determine the maximum tolerated dose (MTD) for this administration schedule. Up to approximately 30 additional patients will be entered at one or more dose levels at or below the MTD in order to determine the optimal dose for subsequent studies.

Being tested
milatuzumab
Keywords
multiple myeloma, Myeloma, Plasma-Cell, PLASMACYTOMA
Medical subject headings
Multiple Myeloma, Plasmacytoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • milatuzumabBiological

    Also called CD74, humanized CD74, IMMU-115, hLL1

    twice weekly dosing for 4 weeks, total of 8 doses

Study groups in NCT00421525
Study groupRoleWhat they receive
Multiple DosesOtherMultiple Dose levels
Receives: Biological: milatuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. safety and tolerability of hLL1 administered twice weekly for 4 consecutive weeks

    Measured: first 12 weeks, then over 2 years

Secondary outcomes (1)

  1. The secondary objectives are to obtain information on efficacy, pharmacodynamics, pharmacokinetics, and immunogenicity, and to determine the optimal dose for subsequent studies.

    Measured: first 12 weeks, then over 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00421525
Sponsor's protocol ID
PROTOCOL: IMMU-115-01
Status last verified
Feb 2021
First submitted
11 Jan 2007
Last updated
16 Aug 2021
Results posted
No
Data monitoring committee
No

Publications

  • Sapra P, et al. In vitro and in vivo targeting and therapy of an antibody-drug conjugate (IMMU-110) in B-cell malignancies. (Abstract #3287) Blood 2004; 104/11:898a.

  • Stein R, et al. Therapeutic activity of a new antibody-drug immunoconjugate, IMMU-110, in preclinical studies targeted against multiple myeloma. (Abstract #6535) Proceedings of ASCO 2004; 23:564.

  • Griffiths GL, et al. Promising therapeutic activity of a new drug immunoconjugate, IMMU-110, in a human Burkitt lymphoma model. (Abstract #2381) Blood 2003; 102/11:645a

  • Sapra P, et al. Preclinical safety and efficacy of two novel immunotoxins consisting of Ranpirnase (Rap) fused to an internalizing anti-CD74 humanized IgG4 antibody in human non-Hodgkin's lymphoma xenografts. (Abstract #346) Blood 2005; 106/11:105a

  • Stein R, Qu Z, Cardillo TM, Chen S, Rosario A, Horak ID, Hansen HJ, Goldenberg DM. Antiproliferative activity of a humanized anti-CD74 monoclonal antibody, hLL1, on B-cell malignancies. Blood. 2004 Dec 1;104(12):3705-11. doi: 10.1182/blood-2004-03-0890. Epub 2004 Aug 5.

    PubMed 15297317

  • Vanama SS, et al. Construction and characterization of a novel ribonuclease immunotoxin consisting of two Ranpirnase (Rap) molecules fused to an internalizing anti-CD74 humanized IgG4 antibody. (Abstract #3289) Blood 2004; 104/11:899a.

  • Burton JD, Ely S, Reddy PK, Stein R, Gold DV, Cardillo TM, Goldenberg DM. CD74 is expressed by multiple myeloma and is a promising target for therapy. Clin Cancer Res. 2004 Oct 1;10(19):6606-11. doi: 10.1158/1078-0432.CCR-04-0182.

    PubMed 15475450

  • Griffiths GL, Mattes MJ, Stein R, Govindan SV, Horak ID, Hansen HJ, Goldenberg DM. Cure of SCID mice bearing human B-lymphoma xenografts by an anti-CD74 antibody-anthracycline drug conjugate. Clin Cancer Res. 2003 Dec 15;9(17):6567-71.

    PubMed 14695162

  • Ong GL, Goldenberg DM, Hansen HJ, Mattes MJ. Cell surface expression and metabolism of major histocompatibility complex class II invariant chain (CD74) by diverse cell lines. Immunology. 1999 Oct;98(2):296-302. doi: 10.1046/j.1365-2567.1999.00868.x.

    PubMed 10540230

  • Kaufman JL, Niesvizky R, Stadtmauer EA, Chanan-Khan A, Siegel D, Horne H, Wegener WA, Goldenberg DM. Phase I, multicentre, dose-escalation trial of monotherapy with milatuzumab (humanized anti-CD74 monoclonal antibody) in relapsed or refractory multiple myeloma. Br J Haematol. 2013 Nov;163(4):478-86. doi: 10.1111/bjh.12565. Epub 2013 Sep 25.

    PubMed 24112026

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing milatuzumab in people with Multiple Myeloma and Myeloma, Plasma-Cell, run by Gilead Sciences at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

safety and tolerability of hLL1 administered twice weekly for 4 consecutive weeks (time frame: first 12 weeks, then over 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00421525, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.

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