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Multiple Myeloma and Plasma Cell NeoplasmPhase 2AntiCD-66NCT00637767

High-Dose Melphalan With or Without Radiolabeled Monoclonal Antibody in Treating Patients With Multiple Myeloma Undergoing an Autologous Stem Cell Transplant

A Phase 2 study testing melphalan, autologous hematopoietic stem cell transplantation and yttrium Y 90 anti-CD66 monoclonal antibody BW 250/183 in people with Multiple Myeloma and Plasma Cell Neoplasm, run by University of Southampton at 3 sites in United Kingdom.

Terminated

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

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiolabeled monoclonal antibodies can find cancer cells and carry cancer-killing substances to them without harming normal cells. Read more about this study

Who is it for?
Ages 18 to 120 years
What is being tested?
melphalan, autologous hematopoietic stem cell transplantation and yttrium Y 90 anti-CD66 monoclonal antibody BW 250/183
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
3 sitesUnited Kingdom
Study dates
1 Dec 2007to 31 Oct 2013
Phase
Phase 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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically proven multiple myeloma (MM)
  • Scheduled to undergo autologous hematopoietic stem cell transplantation (HSCT) as consolidation treatment for MM
  • Must have sufficient CD34-positive stem cells (≥ 4 x 10^6 cells per kg body weight) in cryo-storage for two autologous HSCTs
  • In partial remission (PR) after prior chemotherapy but before priming therapy for stem cell mobilization
  • Patients in complete remission (CR) after prior chemotherapy are not eligible
  • Bone marrow cellularity ≥ 20%

PATIENT CHARACTERISTICS:

  • WHO performance status 0-1
  • Life expectancy ≥ 24 weeks
  • Hemoglobin ≥ 9.0 g/dL
  • Neutrophils ≥ 1,500/mm³
  • Platelets ≥ 50,000/mm³
  • Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT and/or AST ≤ 2.5 times ULN
  • Creatinine clearance ≥ 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile female patients must use effective contraception for 4 weeks prior to, during, and for 6 months after completion of study treatment
  • Fertile male patients must use effective contraception during and for 6 months after completion of study treatment
  • Able to cooperate with study treatment and follow up
  • Human anti-mouse antibody (HAMA) negative
  • No active uncontrolled infection
  • No high-risk non-malignant systemic disease
  • No other condition, that in the investigator's opinion, would make the patient an unsuitable candidate for the study
  • No known HIV or hepatitis B or C seropositivity
  • No history of allergy, including an allergy to rodents or rodent proteins
  • No history of eczema or asthma
  • No history of New York Heart Association (NYHA) class III or IV cardiac disease
  • No congestive heart failure

PRIOR CONCURRENT THERAPY:

  • Recovered from prior therapy
  • Alopecia or certain grade 1 toxicities allowed
  • More than 4 weeks since prior radiotherapy (except for localized pain control), endocrine therapy, or immunotherapy
  • More than 4 weeks since prior and no other concurrent chemotherapy for the underlying hematological condition, except for the following:
  • Cyclophosphamide as priming for stem cell harvest
  • Thalidomide
  • More than 3 weeks since prior major thoracic and/or abdominal surgery and recovered
  • No prior high-dose therapy and autologous HSCT
  • Concurrent radiotherapy allowed for the control of bone pain
  • The irradiated lesions are not used for response evaluation
  • No other concurrent anti-cancer therapy or investigational drugs during transplantation conditioning

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites

  • Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

    Birmingham, England, B15 2TH

  • Saint Bartholomew's Hospital

    London, England, EC1A 7BE

  • Southampton General Hospital

    Southampton, England, SO16 6YD

Other trials in United Kingdom

About this study

Official title: A Randomised Phase II Clinical Trial Using Targeted Radiotherapy Delivered by an Yttrium-90 Radio-Labelled Anti-CD66 Monoclonal Antibody With High Dose Melphalan Compared to Melphalan Alone, Prior to Autologous Stem Cell Transplantation for Multiple Myeloma

RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiolabeled monoclonal antibodies can find cancer cells and carry cancer-killing substances to them without harming normal cells. A stem cell transplant using stem cells from the patient may be able to replace blood-forming cells that were destroyed by the chemotherapy and radiolabeled monoclonal antibody.

PURPOSE: This randomized phase II trial is studying how well high-dose melphalan works when given with or without radiolabeled monoclonal antibody in treating patients with multiple myeloma undergoing an autologous stem cell transplant.

Read the detailed description

OBJECTIVES:

Primary

  • To determine the efficacy of high-dose melphalan (200mg/m²) in combination with targeted radiotherapy delivered by yttrium Y 90 anti-CD66 monoclonal antibody BW250/183, in terms of disease response (complete remission rate and change in serum free light chain level before and after treatment with yttrium Y 90 anti-CD66 monoclonal antibody BW250/183), in patients undergoing autologous hematopoietic stem cell transplantation for multiple myeloma.

Secondary

  • To determine the toxicity profile of yttrium Y 90 anti-CD66 monoclonal antibody BW250/183 in the context of autologous hematopoietic stem cell transplantation.
  • To determine the effect of targeted radiotherapy on other parameters of disease response, in terms of proportion of patients with partial remission, stable disease, and progressive disease, remission duration (time to disease progression), and overall survival.
  • To determine the effect of targeted radiotherapy on engraftment when used in combination with high-dose melphalan in patients undergoing autologous hematopoietic stem cell transplantation for multiple myeloma.
  • To investigate the pharmacokinetic behavior of indium In 111 anti-CD66 monoclonal antibody BW250/183 (used for dosimetry).
  • To continue to develop a dosimetry model based on single-photon emission computed tomography (SPECT) and whole body gamma camera imaging following administration of the radiolabeled anti-CD66 monoclonal antibody (in a subset of patients at the Southampton site only).
  • To assess the proportion of patients who form human anti-murine antibodies (HAMA) after treatment with targeted radiotherapy in the context of an autologous hematopoietic stem cell transplantation.

OUTLINE: This is a multicenter study. Patients are stratified according to disease risk group (low risk [beta-2 microglobulin and C-reactive protein < 6 or either beta-2 microglobulin or C-reactive protein ≥ 6] vs high risk [both beta-2 microglobulin and C-reactive protein ≥ 6]). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive a dosimetry dose of indium In 111 anti-CD66 monoclonal antibody BW250/183 IV on day 1 and undergo gamma camera imaging and serial blood samples on days 1-5. Patients then receive a therapeutic dose of yttrium Y 90 anti-CD66 monoclonal antibody BW250/183 IV once between days 9 and 16 and high-dose melphalan IV on day 28. Patients then undergo autologous hematopoietic stem cell transplantation (HSCT) on day 30.
  • Arm II: Patients receive high-dose melphalan IV on day 1. Patients then undergo autologous HSCT on day 3.

Patients in arm I undergo blood sample collection periodically for pharmacokinetic and pharmacodynamic studies and analysis of human anti-murine antibody (HAMA) status.

After completion of study treatment, patients are followed periodically.

Being tested
melphalan, autologous hematopoietic stem cell transplantation, yttrium Y 90 anti-CD66 monoclonal antibody BW 250/183
Keywords
stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Medical subject headings
Multiple Myeloma, Neoplasms, Plasma Cell

What participants receive

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

  • melphalanDrug

  • autologous hematopoietic stem cell transplantationProcedure or surgery

  • yttrium Y 90 anti-CD66 monoclonal antibody BW 250/183Radiation

Study groups in NCT00637767
Study groupRoleWhat they receive
radio-labelled anti-CD66 monoclonal antibodyExperimentalUp to 4mg radio-labelled anti-CD66 monoclonal antibody. Plus standard treatment
Receives: Drug: melphalan; Procedure: autologous hematopoietic stem cell transplantation; Radiation: yttrium Y 90 anti-CD66 monoclonal antibody BW 250/183
No IMP - standard treatmentActive comparatorNo IMP - standard treatment
Receives: Drug: melphalan; Procedure: autologous hematopoietic stem cell transplantation

What is being measured

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

  1. Remission status pre- and post-transplantation, specifically the number of patients who achieve complete remission, as measured by the European Blood and Marrow Transplantation Organization Response Criteria

    Measured: end of study

Secondary outcomes (9)

  1. Disease response, as measured by changes in serum free light chains (in those patients with serum free light chains that are informative)

    Measured: end of study

  2. Disease response, including the proportion of patients with partial remission, stable disease, and progressive disease and remission duration (time to disease progression)

    Measured: end of study

  3. Engraftment quality, as measured by time to recovery of peripheral blood neutrophils to > 500/mm³ and platelets > 50, 000/mm³ and duration of recovery for > 180 days post-transplantation

    Measured: end of study

  4. Treatment-related mortality

    Measured: end of study

  5. Overall survival

    Measured: end of study

  6. Toxicity profile of yttrium Y 90 anti-CD66 monoclonal antibody BW250/183 in the context of autologous stem cell transplantation

    Measured: end of study

  7. Pharmacokinetics of indium In 111 anti-CD66 monoclonal antibody BW250/183 as measured by serial blood samples and serial planar and single-photon emission computed tomography (SPECT) gamma camera imaging of selected organs

    Measured: end of study

  8. Development of a dosimetry model based on SPECT and whole body gamma camera imaging

    Measured: end of study

  9. Proportion of patients who form human anti-murine antibodies (HAMA) after treatment with targeted radiotherapy in the context of an autologous hematopoietic stem cell transplantation

    Measured: end of study

Timeline

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

  1. First posted18 Mar 2008 (estimated)
  2. Study start1 Dec 2007
  3. Primary completion31 Oct 2013
  4. Study completion31 Oct 2013

Why it stopped: Low recruitment

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00637767
Sponsor's protocol ID
CDR0000588063
Other IDs
2006-003424-12, EU-20820
Acronym
AntiCD-66
Status last verified
Dec 2020
First submitted
14 Mar 2008
Last updated
23 Dec 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing melphalan, autologous hematopoietic stem cell transplantation and yttrium Y 90 anti-CD66 monoclonal antibody BW 250/183 in people with Multiple Myeloma and Plasma Cell Neoplasm, run by University of Southampton at 3 sites in United Kingdom.

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

Who may be eligible to take part?

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 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. 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 phase mean?

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: Low recruitment). 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?

Remission status pre- and post-transplantation, specifically the number of patients who achieve complete remission, as measured by the European Blood and Marrow Transplantation Organization Response Criteria (time frame: end of study). 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 NCT00637767.

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 23 Dec 2020.

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