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Multiple MyelomaPhase 1/2NCT01101594

A Study of hLL1-DOX (Milatuzumab-Doxorubicin Antibody-Drug Conjugate) in Patients With Multiple Myeloma

A Phase 1/2 study testing hLL1-DOX (the doxorubicin conjugate of milatuzumab) in people with Multiple Myeloma, run by Gilead Sciences at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is a Ph I trial to test the safety of the study drug, hLL1-DOX at different dose levels in patients with recurrent multiple myeloma. HLL1 is also known as milatuzumab and is attached to doxorubicin in this clinical trial. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
hLL1-DOX (the doxorubicin conjugate of milatuzumab)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
5 sitesUnited States
Study dates
Jul 2010to Jul 2013
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;
  • Multiple myeloma with one or more criteria for measurable disease (serum M protein > 0.5 gm/dl, urinary M protein excretion > 200 mg/24 hours, serum free light chain measurement >20 mg/dl,);
  • Refractory or relapsed to at least two prior standard systemic anti-myeloma treatment regimens one of which must include either thalidomide, lenalidomide or bortezomib;
  • Adequate performance status (Karnofsky Scale >/= 70%);
  • Life expectancy at least 6 months;
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  • Adequate cardiac function: MUGA scan or 2D-ECHO with LVEF 55%, EKG with no medically relevant arrhythmia uncontrolled on medications;
  • Adequate hematologic status within 2 weeks before study drug administration:
  • Hemoglobin >/=8.0 g/dL and platelets >/=75,000/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) >/=1,500/mm3 (both without the use of colony stimulating factors within 7 days of laboratory testing);
  • Adequate renal function: serum creatinine </+ 2.5 mg/mL;
  • Adequate hepatic function
  • AST and ALT </= 2.5 x the ULN
  • Total bilirubin </= 1.5 x the ULN

Who cannot join

  • 1. Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test Pregnancy testing is not required for post-menopausal or surgically sterilized women;
  • Patients who are eligible for stem cell transplant.
  • 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-dox infusion;
  • Prior local radiotherapy within 14 days; chemotherapy or kyphoplasty within 21 days, immunotherapy, plasmapheresis, or major surgery within 28 days; prior stem cell transplant within 12 weeks.
  • Must have no persistent ≥ Grade 2 toxicity from prior treatments;
  • Prior treatment with any other therapeutic agents for MM or investigational agents within 4 weeks, unless off study, and agreed by Sponsor;
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  • A history of allergic or adverse reactions to anthracycline/anthracenedione agents;
  • Cumulative life-time anthracycline/anthracenedione exposure exceeding 300 mg/m2 (including daunorubicin, idarubicin, epirubicin or mitoxantrone);
  • Known to be HIV positive, or any prior hepatitis B or C infection;
  • Any history of clinically significant autoimmune disease (e.g., collagen vascular disorders, autoimmune hepatitis, Coombs positive anemia/thrombocytopenia, etc.)
  • Prior history of mediastinal or pericardial external beam radiation therapy.
  • Prior history of treatment with trastuzumab, unless discussed with and agreed to by Medical Monitor.
  • 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

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Georgia Cancer Specialists

    Atlanta, Georgia, 30068

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • MD Anderson Center

    Houston, Texas, 77030

  • MD Anderson Orlando

    Orlando, Florida, 32806

  • University Hospital of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Phase I/II Study of hLL1-DOX (Milatuzumab-Doxorubicin Antibody-Drug Conjugate) in Patients With Multiple Myeloma

This study is a Ph I trial to test the safety of the study drug, hLL1-DOX at different dose levels in patients with recurrent multiple myeloma. HLL1 is also known as milatuzumab and is attached to doxorubicin in this clinical trial.

Read the detailed description

In this clinical research trial, hLL1-DOX will be administered on days 1, 4, 8 and 11. This treatment cycle will be repeated every 3 weeks as long as patients continue to tolerate it, for a maximum of 8 treatment cycles (approximately 6 months).

Being tested
hLL1-DOX (the doxorubicin conjugate of milatuzumab)
Keywords
Treatment, Multiple Myeloma, Relapsed, refractory multiple myeloma
Medical subject headings
Multiple Myeloma, Recurrence

What participants receive

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

  • hLL1-DOX (the doxorubicin conjugate of milatuzumab)Drug

    Also called hLL1-DOX, Milatuzumab-DOX, CD74-DOX

    hLL1-DOX will be administered intravenously (through a vein) on days 1, 4, 8 \& 11 every 21 days for up to 8 treatment cycles. 4 different dose levels of hLL1-DOX will be studied for safety and tolerability.

Study groups in NCT01101594
Study groupRoleWhat they receive
hLL1-DOXExperimental4 Different dose levels of hLL1-DOX will be studied in groups of 3-6 patients. Once an optimal dose has been found, up to additional 30 patients will be studied at that dose level.
Receives: Drug: hLL1-DOX (the doxorubicin conjugate of milatuzumab)

What is being measured

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

  1. All patients administered any dose of study drug will be included in the evaluation of safety

    The frequency and severity of adverse events (AEs) will be tabulated by MedDRA Preferred Term and System Organ Class (SOC) for each dose group. AEs will be classified using the MedDRA version 8.0 with severity assessed by NCI CTC v3 toxicity grades

    Measured: Before infusion, 5 min after start, every 15 min until completion, then 30, 60, 90 and 120 min later of each dose of study drug

Secondary outcomes (1)

  1. Determine the therapeutic efficacy of hLL1-DOX in this patient population

    All patients who were treated with at least one complete dose of study drug and have available response assessment data will constitute the efficacy population. For efficacy evaluations, treatment responses based on IMWG Response Criteria, response duration and progression-free survival will be tabulated and summarized by descriptive statistics for patients in each dose group.

    Measured: During treatment and the changes at 4, 8 and 12 weeks after treatment and then every 3 months for up to 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 Apr 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionJul 2013
  4. Study completionJul 2013

Why it stopped: Study was terminated due to lack of efficacy

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
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01101594
Sponsor's protocol ID
IM-T-hLL1-DOX-01
Status last verified
Mar 2020
First submitted
11 Mar 2010
Last updated
16 Aug 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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

  • 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

  • Pawlak-Byczkowska EJ, Hansen HJ, Dion AS, Goldenberg DM. Two new monoclonal antibodies, EPB-1 and EPB-2, reactive with human lymphoma. Cancer Res. 1989 Aug 15;49(16):4568-77.

    PubMed 2663143

  • Stein R, Gupta P, Chen X, Cardillo TM, Furman RR, Chen S, Chang CH, Goldenberg DM. Therapy of B-cell malignancies by anti-HLA-DR humanized monoclonal antibody, IMMU-114, is mediated through hyperactivation of ERK and JNK MAP kinase signaling pathways. Blood. 2010 Jun 24;115(25):5180-90. doi: 10.1182/blood-2009-06-228288. Epub 2010 Jan 25.

    PubMed 20101022

  • Sapra P, Stein R, Pickett J, Qu Z, Govindan SV, Cardillo TM, Hansen HJ, Horak ID, Griffiths GL, Goldenberg DM. Anti-CD74 antibody-doxorubicin conjugate, IMMU-110, in a human multiple myeloma xenograft and in monkeys. Clin Cancer Res. 2005 Jul 15;11(14):5257-64. doi: 10.1158/1078-0432.CCR-05-0204.

    PubMed 16033844

  • Stein R, Mattes MJ, Cardillo TM, Hansen HJ, Chang CH, Burton J, Govindan S, Goldenberg DM. CD74: a new candidate target for the immunotherapy of B-cell neoplasms. Clin Cancer Res. 2007 Sep 15;13(18 Pt 2):5556s-5563s. doi: 10.1158/1078-0432.CCR-07-1167.

    PubMed 17875789

  • Mark T, Martin P, Leonard JP, Niesvizky R. Milatuzumab: a promising new agent for the treatment of lymphoid malignancies. Expert Opin Investig Drugs. 2009 Jan;18(1):99-104. doi: 10.1517/13543780802636162.

    PubMed 19053886

  • Stein R, Smith MR, Chen S, Zalath M, Goldenberg DM. Combining milatuzumab with bortezomib, doxorubicin, or dexamethasone improves responses in multiple myeloma cell lines. Clin Cancer Res. 2009 Apr 15;15(8):2808-17. doi: 10.1158/1078-0432.CCR-08-1953. Epub 2009 Apr 7.

    PubMed 19351768

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing hLL1-DOX (the doxorubicin conjugate of milatuzumab) in people with Multiple Myeloma, run by Gilead Sciences at 5 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 14 inclusion and 14 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: stopped early, 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 5 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 was stopped early (reason given: Study was terminated due to lack of efficacy). Results are not available in the source record.

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?

All patients administered any dose of study drug will be included in the evaluation of safety (time frame: Before infusion, 5 min after start, every 15 min until completion, then 30, 60, 90 and 120 min later of each dose of study drug). 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 NCT01101594, which also lists 8 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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