Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)

An observational study of Multiple Myeloma, run by Bristol-Myers Squibb at 130 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial summary

The purpose of this study is to assess the clinical effectiveness of all approved multiple myeloma (MM) therapies in the newly-diagnosed (NDMM) and the relapsed/refractory MM (RRMM) settings in real-world clinical practice. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma
How many people: 2,555 participants
Where: 130 sitesin 6 countries
Study dates: 13 Jun 2012to 31 Mar 2030
Phase: Observational
Are there results?: Not yet: the study is under way

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

Study population: The study population will consist of two cohorts: Participants with relapsed/refractory (RR) multiple myeloma (MM) and those with newly-diagnosed (ND) multiple myeloma (MM).

Who may be able to join

For RRMM participants who have received at least one prior line of therapy (LoT) for MM:
Have documented progression from a prior LoT
Participants who have initiated treatment with one of the following therapies within 90 days before consent for this study OR in the case where treatment has not yet been initiated, documentation that the treatment strategy was determined before consent for this study must be provided, and treatment must be initiated within 30 days after consent:
IMiDs
PIs
Combination of IMiD + PI

Show all 14Show fewer

Newer agents with novel MOAs alone or in combination (eg, mAbs, HDACIs, Akt inhibitors, SINE, or CAR T-cell therapies)
For NDMM participants receiving frontline therapy:
Eligible to receive frontline therapy for MM (no prior MM treatment)
Participants who have initiated treatment for MM with one of the following therapies within 90 days before consent for this study OR in the case where treatment has not yet been initiated, documentation that the treatment strategy was determined before consent for this study must be provided, and treatment must be initiated within 30 days after consent:
IMiDs
PIs
Combination of IMiD + PI
Newer agents with novel MOAs alone or in combination (eg, mAbs, HDACIs, Akt inhibitors, SINE, or CAR T-cell therapies)

Who cannot join

Participants who are currently participating in a clinical trial for MM
Participants who are currently receiving treatment for primary cancer other than MM
Participants who are not willing or able to provide informed consent
Participants who are incarcerated
Participants under compulsory detention for treatment of a physical (eg, infectious) or psychiatric illness
Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

130 sites in 6 countries.

Country

City, postcode or hospital

130 sites in 6 countries

United States78 sites

Local Institute
Amarillo, Texas, 79106
Local Institution - 0023
Anaheim, California, 92801
Local Institution
Anaheim, California, 92801
Local Institution - 0058
Anderson, Indiana, 46016
Local Institution
Birmingham, Alabama, 35213
Local Institution
Brooksville, Florida, 34613
Local Institution - 0045
Burbank, California, 91505
Local Institute
Canton, Ohio, 44718
Local Institution - 0022
Canton, Ohio, 44718
Local Institute
Cary, North Carolina, 27518
Local Institution - 0033
Cary, North Carolina, 27518
Local Institute
Charleston, South Carolina, 29414
Local Institution - 0016
Charleston, South Carolina, 29414
Local Institute
Cleveland, Ohio, 44109-1900
Local Institution
Corona, California, 92880
Local Institute
Corpus Christi, Texas, 78350
Local Institute
Dallas, Texas, 75229
Local Institute
Dallas, Texas, 75231
Local Institution - 0025
Dallas, Texas, 75231
Local Institute
Dallas, Texas, 75390
Local Institution - 0014
Dallas, Texas, 75390
Local Institution - 0048
Downey, California, 90241
Local Institution - 0044
Fort Lauderdale, Florida, 33308
Local Institution - 0052
Fountain Valley, California, 92708
Local Institution - 0032
Garland, Texas, 75042
Local Institution - 0010
Gastonia, North Carolina, 28054
Local Institution
Gastonia, North Carolina, 28054
Local Institute
Goodyear, Arizona, 85338
Local Institution - 0011
Indianapolis, Indiana, 46237
Local Institution
Indianapolis, Indiana, 46237
Local Institution
Jacksonville, Florida, 32256
Local Institute
Kansas City, Missouri, 64132
Local Institution - 0050
Kansas City, Missouri, 64132
Local Institute
Knoxville, Tennessee, 37920
Local Institution
Lafayette, Louisiana, 70503
Local Institute
Los Angeles, California, 90013
Local Institute
Louisville, Kentucky, 40201
Local Institution - 0042
Louisville, Kentucky, 40202
Local Institution
Memphis, Tennessee, 38120
Local Institution
Minneapolis, Minnesota, 55404
Local Institution - 0037
Missoula, Missouri, 59802
Local Institute
Missoula, Montana, 59802
Local Institute
Missoula, Montana, 59807
Local Institution - Canada
No City Provided, New Jersey, 00000
Local Institution - France
No City Provided, New Jersey, 00000
Local Institution - Germany
No City Provided, New Jersey, 00000
Local Institution - Italy
No City Provided, New Jersey, 00000
Local Institution - United Kingdom
No City Provided, New Jersey, 00000
Local Institution - USA
No City Provided, New Jersey, 00000
Local Institute
Omaha, Nebraska, 68124
Local Institution - 0024
Omaha, Nebraska, 68124
Local Institute
Portland, Oregon, 97200
Local Institute
Pottstown, Pennsylvania, 19464
Local Institute
Saint Joseph, Missouri, 64501
Local Institute
San Antonio, Texas, 78217
Local Institution - 0027
San Antonio, Texas, 78217
Local Institute
Santa Rosa, California, 95403
Local Institution - 0051
Santa Rosa, California, 95403
Local Institute
Seattle, Washington, 98101
Local Institute
Sherman, Texas, 75090
Local Institution
Shreveport, Louisiana, 71103
Local Institute
Sioux City, Iowa, 51101
Local Institution
Skokie, Illinois, 60077
Local Institute
Southaven, Mississippi, 38671
Local Institute
Spokane, Washington, 99202
Local Institution - 0026
Spokane, Washington, 99202
Local Institution - 0041
Springfield, Illinois, 62794-9677
Local Institution - 0020
Springfield, Missouri, 65804
Local Institution
Springfield, Missouri, 65804
Local Institution
St Louis, Missouri, 63110
Local Institution - 0049
Stony Brook, New York, 11794
Local Institute
Tulsa, Oklahoma, 74136
Local Institute
Valdosta, Georgia, 31602
Local Institution - 0047
Valdosta, Georgia, 31602
Local Institution - 0030
Woodbury, Minnesota, 55125
Local Institute
Yakima, Washington, 98901
Local Institute
Yakima, Washington, 98902
Local Institution - 0031
Yakima, Washington, 98902

Other trials in United States

Italy23 sites

Local Institute
Ancona, 042002
Local Institute
Ancona, 60126
Local Institution - 0119
Cagliari, 09121
Local Institute
Cagliari, B354
Local Institution - 0111
Florence, 50134
Local Institute
Florence, 50139
Local Institute
Lecce, 73100
Local Institution - 0120
Messina, 98122
Local Institute
Milan, 20121
Local Institution - 0116
Milan, 20133
Local Institute
Naples, 80136
Local Institution - 0114
Naples, 80139
Local Institute
Pesaro, Pesaro E Urbino, 61122
Local Institution - 0115
Pesaro, 61122
Local Institution - 0121
Pescara, 65124
Local Institute
Roma, 00161
Local Institution
Roma, 00189
Local Institution - 0107
Terni, 05100
Local Institute
Terni, 5100
Local Institute
Torino, 10126
Local Institution - 0112
Torino, 10126
Local Institute
Vicenza, 36100
Local Institution - 0117
Vicenza, 36100

Other trials in Italy

Germany11 sites

Local Institute
Aschaffenburg, 63739
Local Institute
Berlin, 10407
Local Institute
Dresden, 01099
Local Institute
Hamm, North Rhine-Westphalia, 59071
Local Institution - 0070
Hamm, 59071
Local Institute
Heidelberg, Baden-Wurttemberg, 69120
Local Institute
Magdeburg, 39104
Local Institution - 0067
Magdeburg, 39104
Local Institute
München
Local Institute
Rostock
Local Institution - 0085
Wiesbaden, 65191

Other trials in Germany

France8 sites

Local Institute
Blois
Local Institute
Chalon-sur-Saône
Local Institution - 0100
La Roche-sur-Yon, 85925
Local Institute
La Roche-sur-Yon
Local Institute
Limoges
Local Institute
Meaux
Local Institute
Nantes
Local Institute
Rennes, 35033

Other trials in France

United Kingdom7 sites

Local Institute
Leeds, LS9 7TF
Local Institution
Liverpool, L7 8XP
Local Institute
Nottingham, NG5 1PB
Local Institution - 0095
Nottingham, NG5 1PB
Local Institute
Stafford, ST16 3SA
Local Institute
Swansea, SA2 8QA
Local Institute
Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

Canada3 sites

Local Institute
Toronto, Ontario, M4N 3M5
Local Institution - 0066
Toronto, Ontario, M5G 2M9
Local Institute
Weston, Ontario, M9N 1N8

Other trials in Canada

About this study

Conditions: 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 NCT01838512
Study group	Role	What they receive
Cohort 1		Participants with relapsed/refractory multiple myeloma (RRMM) followed up for up to 5 years
Cohort 2		Participants with newly-diagnosed multiple myeloma (NDMM) followed up for up to 8 years

What is being measured

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

Overall Survival (OS) for participants with relapsed/refractory multiple myeloma (RRMM)
Measured: Up to 5 years
Overall Survival (OS) for participants with newly-diagnosed multiple myeloma (NDMM)
Measured: Up to 8 years
Progression-Free Survival (PFS) for participants with RRMM
Measured: Up to 5 years
Progression-Free Survival (PFS) for participants with NDMM
Measured: Up to 8 years

Secondary outcomes (14)

Treatment patterns of approved MM therapies as measured by the Response Rate for participants with RRMM
Measured: From study index date until the enrollment date, assessed up to 5 years
Treatment patterns of approved MM therapies as measured by the Response Rate for participants with NDMM
Measured: From study index date until the enrollment date, assessed up to 8 years
Healthcare resource utilization (HCRU) for participants with RRMM
Measured: Up to 5 years
Healthcare resource utilization (HCRU) for participants with NDMM
Measured: Up to 8 years
Healthcare resource utilization (HCRU) for participants with RRMM
Measured: From the day of enrollment until death, withdrawal of consent, enrollment into a clinical trial for MM, loss to follow-up, or end of study, whichever comes first; assessed up to 60 months
Healthcare resource utilization (HCRU) for participants with NDMM
Measured: From the day of enrollment until death, withdrawal of consent, enrollment into a clinical trial for MM, loss to follow-up, or end of study, whichever comes first; assessed up to 96 months
Patient reported outcomes as measured by EQ-5D summary index for participants with RRMM
Measured: From start of initial therapy to questionnaire completion, assessed up to 5 years
Patient reported outcomes as measured by EQ-5D summary index for participants with NDMM
Measured: From start of initial therapy to questionnaire completion, assessed up to 8 years
Patient reported outcomes as measured by EORTC-QLQ-C30 for participants with RRMM
Measured: From start of initial therapy to questionnaire completion, assessed up to 5 years
Patient reported outcomes as measured by EORTC-QLQ-C30 for participants with NDMM
Measured: From start of initial therapy to questionnaire completion, assessed up to 8 years
Patient reported outcomes as measured by EORTC-QLQ-MY20 for participants with RRMM
Measured: From start of initial therapy to questionnaire completion, assessed up to 5 years
Patient reported outcomes as measured by EORTC-QLQ-MY20 for participants with NDMM
Measured: From start of initial therapy to questionnaire completion, assessed up to 8 years
Incidence of Adverse Events (AEs) for participants with RRMM
Measured: Up to 5 years
Incidence of Adverse Events (AEs) for participants with NDMM
Measured: Up to 8 years

Timeline

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

13 Jun 201231 Mar 2030

First posted24 Apr 2013 (estimated)
Study start13 Jun 2012
Primary completion31 Mar 2030 (estimated)
Study completion31 Mar 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Multiple MyelomaStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 2,555 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01838512
Sponsor's protocol ID: CA204-008
Status last verified: Dec 2025
First submitted: 19 Apr 2013
Last updated: 2 Dec 2025
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)
ClinicalTrials.gov ID: NCT01838512
Acronym / sponsor ID: CA204-008
Conditions: Multiple Myeloma
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 2,555 participants (estimated)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 13 Jun 2012 (actual)
Primary completion: 31 Mar 2030 (estimated)
Study completion: 31 Mar 2030 (estimated)
First posted: 24 Apr 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Cohort 1	–	–Participants with relapsed/refractory multiple myeloma (RRMM) followed up for up to 5 years
Cohort 2	–	–Participants with newly-diagnosed multiple myeloma (NDMM) followed up for up to 8 years

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study population will consist of two cohorts: Participants with relapsed/refractory (RR) multiple myeloma (MM) and those with newly-diagnosed (ND) multiple myeloma (MM).

Key inclusion criteria (14 listed)

Have documented progression from a prior LoT
Participants who have initiated treatment with one of the following therapies within 90 days before consent for this study OR in the case where treatment has not yet been initiated, documentation that the treatment strategy was determined before consent for this study must be provided, and treatment must be initiated within 30 days after consent:
IMiDs
PIs
Combination of IMiD + PI

Key exclusion criteria (6 listed)

Participants who are currently participating in a clinical trial for MM
Participants who are currently receiving treatment for primary cancer other than MM
Participants who are not willing or able to provide informed consent
Participants who are incarcerated
Participants under compulsory detention for treatment of a physical (eg, infectious) or psychiatric illness

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Overall Survival (OS) for participants with relapsed/refractory multiple myeloma (RRMM)
Time frame: Up to 5 years
Overall Survival (OS) for participants with newly-diagnosed multiple myeloma (NDMM)
Time frame: Up to 8 years
Progression-Free Survival (PFS) for participants with RRMM
Time frame: Up to 5 years
Progression-Free Survival (PFS) for participants with NDMM
Time frame: Up to 8 years

14 secondary outcomes

Treatment patterns of approved MM therapies as measured by the Response Rate for participants with RRMM
Time frame: From study index date until the enrollment date, assessed up to 5 years
Treatment patterns of approved MM therapies as measured by the Response Rate for participants with NDMM
Time frame: From study index date until the enrollment date, assessed up to 8 years
Healthcare resource utilization (HCRU) for participants with RRMM
Time frame: Up to 5 years
Healthcare resource utilization (HCRU) for participants with NDMM
Time frame: Up to 8 years
Healthcare resource utilization (HCRU) for participants with RRMM
Time frame: From the day of enrollment until death, withdrawal of consent, enrollment into a clinical trial for MM, loss to follow-up, or end of study, whichever comes first; assessed up to 60 months
Healthcare resource utilization (HCRU) for participants with NDMM
Time frame: From the day of enrollment until death, withdrawal of consent, enrollment into a clinical trial for MM, loss to follow-up, or end of study, whichever comes first; assessed up to 96 months
Patient reported outcomes as measured by EQ-5D summary index for participants with RRMM
Time frame: From start of initial therapy to questionnaire completion, assessed up to 5 years
Patient reported outcomes as measured by EQ-5D summary index for participants with NDMM
Time frame: From start of initial therapy to questionnaire completion, assessed up to 8 years
Patient reported outcomes as measured by EORTC-QLQ-C30 for participants with RRMM
Time frame: From start of initial therapy to questionnaire completion, assessed up to 5 years
Patient reported outcomes as measured by EORTC-QLQ-C30 for participants with NDMM
Time frame: From start of initial therapy to questionnaire completion, assessed up to 8 years
Patient reported outcomes as measured by EORTC-QLQ-MY20 for participants with RRMM
Time frame: From start of initial therapy to questionnaire completion, assessed up to 5 years
Patient reported outcomes as measured by EORTC-QLQ-MY20 for participants with NDMM
Time frame: From start of initial therapy to questionnaire completion, assessed up to 8 years
Incidence of Adverse Events (AEs) for participants with RRMM
Time frame: Up to 5 years
Incidence of Adverse Events (AEs) for participants with NDMM
Time frame: Up to 8 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
BMS Clinical Trial InformationLink provided by the sponsor.

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

130 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Myeloma, run by Bristol-Myers Squibb at 130 sites in 6 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 14 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 130 sites in United States, Italy, Germany, France, United Kingdom and 1 more country. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Overall Survival (OS) for participants with relapsed/refractory multiple myeloma (RRMM) (time frame: Up to 5 years). The study lists 4 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 NCT01838512.

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 2 Dec 2025.