Prospective Research Assessment in Multiple Myeloma: An O... | NCT01838512

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 13, 2012Actual

Primary Completion Date

Mar 31, 2030Estimated

Completion Date

Mar 31, 2030Estimated

First Submitted Date

Apr 19, 2013

First Submission Date that Met QC Criteria

Apr 23, 2013

First Posted Date

Apr 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2025

Last Update Posted Date

Dec 2, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,555Estimated

Label	Type	Description	Intervention Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Treatment patterns of approved MM therapies as measured by the Response Rate for participants with RRMM		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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

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
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)

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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).

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Birmingham	Alabama	35213	United States
Local Institute

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006474	Hemorrhagic Disorders
D008232	Lymphoproliferative Disorders
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases