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Multiple MyelomaPhase 1/2NCT02605356

Phase 1b/2 Study Testing Radium-223 Dichloride/Bortezomib/Dexamethasone Combination in Relapsed Multiple Myeloma

A Phase 1/2 study testing Radium-223 dichloride (Xofigo, BAY88-8223), Bortezomib and Dexamethasone in people with Multiple Myeloma, run by Bayer at 58 sites in 11 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study will be conducted in 2 parts. The phase 1b part will be an international, phase 1b, open-label, dose-escalation assessment of radium-223 dichloride administered with bortezomib and dexamethasone in subjects with relapsed multiple myeloma. 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?
Radium-223 dichloride (Xofigo, BAY88-8223), Bortezomib and Dexamethasone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
58 sitesin 11 countries
Study dates
Oct 2016to Jul 2021
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

  • Cytologically or histologically confirmed diagnosis of multiple myeloma
  • Subjects must have received at least 1 and not more than 3 previous lines of treatment and have had a response to treatment (i.e., achieved a minimal response [MR] or better) according to the International Myeloma Working Group (IMWG) uniform response criteria
  • Subjects must have had progressive disease according to the IMWG uniform response criteria following the last multiple myeloma treatment
  • Subjects must have measurable disease defined as at least 1 of the following (according to central laboratory results):
  • Serum M-protein ≥1 g/dL
  • Urine M-protein ≥200 mg/24 hours
Show all 11Show fewer
  • Serum free light chain (FLC) ≥10 mg/dL with abnormal ratio
  • ≥1 bone lesion identifiable by radiograph, computed tomography, magnetic resonance imaging, or bone scintigraphy
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2
  • Subjects must be nonrefractory to bortezomib and had no progression during or within 60 days after completion of bortezomib
  • Absolute neutrophil count (ANC) ≥1.5 × 10e9/L, hemoglobin (Hb) ≥9.0 g/dL, and platelet count ≥75.0 × 10e9/L independent of transfusion of red blood cells (RBC) or platelet concentrates and independent of granulocyte colony stimulating factor (G-CSF) or granulocyte macrophage colony stimulating factor (GM-CSF)

Who cannot join

  • Systemic glucocorticoid therapy (prednisone >10 mg/day orally or equivalent) within the last 4 weeks prior to first dose, unless tapered and on a stable dose ≤10 mg/day for at least 1 week
  • Subjects with known POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or light chain (AL) amyloidosis
  • Plasma cell leukemia
  • Systemic anti-cancer therapy within 4 weeks prior to first dose
  • Radiation therapy in the previous 4 weeks prior to first dose except if given for pain management and involves less than 10% of the bone marrow
  • Prior treatment with radium-223 dichloride or any experimental radiopharmaceutical
  • Congestive heart failure (New York Heart Association [NYHA] class III to IV), symptomatic cardiac ischemia, cardiomyopathy, clinically relevant ventricular arrhythmia, pericardial disease, unstable angina or myocardial infarct in the previous 6 months prior to first dose, left ventricular ejection fraction <40%
  • Neuropathy ≥ Grade 2 or Grade 1 with pain

Trial locations and contacts

58 sites in 11 countries.

58 sites in 11 countries

United States10 sites

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Encinitas, California, 92024

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    New York, New York, 10032-3729

  • Study site

    Rockville, Maryland, 20850-6535

  • Study site

    Scottsdale, Arizona, 85259-5404

  • Study site

    Seattle, Washington, 98104

  • Study site

    Watertown, South Dakota, 57201

  • Study site

    Winston-Salem, North Carolina, 27157

Other trials in United States

Italy9 sites

  • Study site

    Bologna, Emilia-Romagna, 40138

  • Study site

    Cagliari, Sardinia, 09121

  • Study site

    Florence, Tuscany, 50141

  • Study site

    Milan, Lombardy, 20089

  • Study site

    Milan, Lombardy, 20132

  • Study site

    Novara, Piedmont, 28100

  • Study site

    Pisa, Tuscany, 56126

  • Study site

    Reggio Emilia, Emilia-Romagna, 42123

  • Study site

    Turin, Piedmont, 10126

Other trials in Italy

Spain9 sites

  • Study site

    Badalona, Barcelona, 08916

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    Barcelona, 08035

  • Study site

    Madrid, Madrid, 28006

  • Study site

    Madrid, Madrid, 28046

  • Study site

    Palma de Mallorca, Illes Baleares, 07010

  • Study site

    San Sebastián, Guipúzcoa, 20014

  • Study site

    Seville, Sevilla, 41013

  • Study site

    Valencia, Valencia, 46017

Other trials in Spain

South Korea7 sites

  • Study site

    Daegu, 700-701

  • Study site

    Goyang-si, Gyeonggido, 410-769

  • Study site

    Jeollanam-do, 519-763

  • Study site

    Seoul, 03080

  • Study site

    Seoul, 135-710

  • Study site

    Seoul, 137-701

  • Study site

    Seoul, 138-736

Other trials in South Korea

Belgium5 sites

  • Study site

    Bruges, 8000

  • Study site

    Bruxelles - Brussel, 1090

  • Study site

    Bruxelles - Brussel, 1200

  • Study site

    Liège, 4000

  • Study site

    Yvoir, 5530

Other trials in Belgium

Israel5 sites

  • Study site

    Afula, 1834111

  • Study site

    Haifa, 31048

  • Study site

    Jerusalem, 9112001

  • Study site

    Ramat Gan, 5262000

  • Study site

    Tsrifin, 6093000

Other trials in Israel

Germany4 sites

  • Study site

    Berlin, State of Berlin, 12203

  • Study site

    Mainz, Rhineland-Palatinate, 55131

  • Study site

    München, Bavaria, 81377

  • Study site

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Taiwan4 sites

  • Study site

    Taichung, 40447

  • Study site

    Taipei, Taipei, 10016

  • Study site

    Taipei, 11217

  • Study site

    Taipei

Other trials in Taiwan

Australia2 sites

  • Study site

    Adelaide, South Australia, 5000

  • Study site

    Box Hill, 3128

Other trials in Australia

Greece2 sites

  • Study site

    Athens, 11528

  • Study site

    Rio / Patra, 26500

Other trials in Greece

Canada1 site

  • Study site

    Québec, Quebec, G1R 2J6

Other trials in Canada

About this study

Official title: A Phase 1b/2 Trial to Evaluate the Safety and Efficacy of Radium-223 Dichloride (BAY88-8223) in Combination With Bortezomib and Dexamethasone in Early Relapsed Multiple Myeloma

This study will be conducted in 2 parts. The phase 1b part will be an international, phase 1b, open-label, dose-escalation assessment of radium-223 dichloride administered with bortezomib and dexamethasone in subjects with relapsed multiple myeloma. The primary endpoint of the phase 1b part is to determine the optimal dose of radium-223 dichloride in combination with bortezomib/dexamethasone for the Phase 2 portion of the study.

The phase 2 part will be an international, phase 2, double-blind, randomized, placebo-controlled assessment of radium-223 dichloride versus placebo administered with bortezomib and dexamethasone, in subjects with relapsed multiple myeloma. Randomization (1:1) in the phase 2 part will be stratified by:

  • Prior bortezomib treatment (yes, no)
  • Prior treatment (1 prior line of treatment, >1 prior line of treatment) Approximately 30 subjects (10 subjects per cohort) will be enrolled in the phase 1b part of the study and approximately 196 subjects will be enrolled in the phase 2 part of the study.
Being tested
Radium-223 dichloride (Xofigo, BAY88-8223), Placebo, Bortezomib, Dexamethasone
Keywords
Radium-223 dichloride, bortezomib, dexamethasone, early relapsed multiple myeloma, combination therapy multiple myeloma
Medical subject headings
Multiple Myeloma

What participants receive

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

Study groups in NCT02605356
Study groupRoleWhat they receive
Radium-223 dichloride [Phase 1, dose 1]ExperimentalPhase 1: Radium-223 dichloride; 30 kiloBecquerel (kBq)/kg body weight (33 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) every 4 weeks for a total of 6 radium-223 dichloride doses plus SOC bortezomib/dexamethasone.
Receives: Drug: Radium-223 dichloride (Xofigo, BAY88-8223); Drug: Bortezomib; Drug: Dexamethasone
Radium-223 dichloride [Phase 1, dose 2]ExperimentalPhase 1: Radium-223 dichloride; 50 kBq/kg body weight (55 kBq/kg after implementation of NIST update) every 4 weeks for a total of 6 radium-223 dichloride doses plus SOC bortezomib/dexamethasone.
Receives: Drug: Radium-223 dichloride (Xofigo, BAY88-8223); Drug: Bortezomib; Drug: Dexamethasone
Radium-223 dichloride [Phase 1, dose 3]ExperimentalPhase 1: Radium-223 dichloride; 80 kBq/kg body weight (88 kBq/kg after implementation of NIST update) every 4 weeks for a total of 6 radium-223 dichloride doses plus SOC bortezomib/dexamethasone.
Receives: Drug: Radium-223 dichloride (Xofigo, BAY88-8223); Drug: Bortezomib; Drug: Dexamethasone
Placebo +SoC [Phase 2]Placebo comparatorPhase 2: Matching placebo (isotonic saline) every 4 weeks for a total of 6 doses plus SoC (Standard of care) bortezomib/dexamethasone.
Receives: Drug: Placebo; Drug: Bortezomib; Drug: Dexamethasone
Radium-223 dichloride + SoC [Phase 2]ExperimentalPhase 2: Phase 1b-selected dose of radium-223 dichloride every 4 weeks for 6 doses plus SOC bortezomib/dexamethasone
Receives: Drug: Radium-223 dichloride (Xofigo, BAY88-8223); Drug: Bortezomib; Drug: Dexamethasone

What is being measured

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

  1. Joint positive adjudication of safety summary in Phase 1b by steering committee, investigator and sponsor (Yes/No)

    Measured: At 13 months

  2. Progression-free survival (PFS) in Phase 2, defined as the time (in days) from date of randomization to disease progression

    Measured: Up to 25 months

Secondary outcomes (9)

  1. Objective response rate (ORR) in Phase 1b, in the proportion of subjects in the analysis population who have complete response (CR), stringent complete response (sCR), very good partial response (VGPR), partial response (PR), or stable disease (SD)

    Measured: Approximately 12 months

  2. Duration of response in Phase 1b, defined as the time (in days) from the date of first response to treatment (CR, sCR, VGPR, PR) to the date of disease progression or death

    Measured: Approximately 12 months

  3. Number of participants with adverse events in phase 2

    Measured: Up to 25 months

  4. Overall survival (OS) in Phase 2, defined as the time (in days) from date of randomization until death from any cause

    Measured: Up to 25 months

  5. Time to Symptomatic Skeletal Event (SSE) in Phase 2, defined as the time (days) from the date of randomization to the date of the first on-study SSE

    Measured: Up to 25 months

  6. Symptomatic skeletal event free survival in Phase 2, defined as the time from randomization to the occurrence of 1 of the following: First on-study SSE or Death from any cause if death occurs before a documented SSE

    Measured: Up to 25 months

  7. Time to pain progression in Phase 2

    Measured: Up to 25 months

  8. Duration of response in Phase 2

    Measured: Up to 25 months

  9. Objective Response Rate (ORR) in Phase 2

    Measured: Up to 25 months

Timeline

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

  1. First posted16 Nov 2015 (estimated)
  2. Study startOct 2016
  3. Primary completionNov 2019 (estimated)
  4. Study completionJul 2021 (estimated)

Why it stopped: Study restarted under new study number 18987

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02605356
Sponsor's protocol ID
17451
Other IDs
2015-000427-82, 2015
Status last verified
Sep 2016
First submitted
12 Nov 2015
Last updated
7 Oct 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Radium-223 dichloride (Xofigo, BAY88-8223), Bortezomib and Dexamethasone in people with Multiple Myeloma, run by Bayer at 58 sites in 11 countries.

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 11 inclusion and 8 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: withdrawn, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, Italy, Spain, South Korea, Belgium and 6 more countries. 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. Some participants in this study may receive a placebo. 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 withdrawn before enrolling participants, so there are no results.

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?

Joint positive adjudication of safety summary in Phase 1b by steering committee, investigator and sponsor (Yes/No) (time frame: At 13 months). The study lists 2 primary outcomes in all. 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 NCT02605356.

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 7 Oct 2016.

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