| Protocol #: |
S2508 |
| Priority #: |
1 |
| Title: |
Phase II Study of Optimal Induction and MRD Driven Maintenance Therapy for Patients with Newly Diagnosed High-Risk Multiple Myeloma (HRMM) |
| Disease Committee: |
Myeloma
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| SCs: Drs. |
Brea Lipe, M.D.; Christine Ye, M.D. |
| Notes: |
02/25/2025: Capsule approved by Triage.
02/25/2025: Internal Study Team Kick off call scheduling pending.
03/19/2025: Internal Study Team Kick off call.
04/21/2025: Internal SWOG NOC and Janssen call to discuss TM funding.
05/12/2025: F&F Call scheduled.
05/28/2025: LOI finalized.
06/17/2025: JNJ determination to support the TM outside of CRADA.
06/30/2025: LOI submitted to PIO.
07/30/2025: PRC comments received, must be re-submitted, 08/13/2025.
08/29/2025: Requested submission extension, LOI re-submitted 08/29/2025.
10/03/2025: Review on Hold received; pending 10/14 resubmission of revised LOI.
10/14/2025: LOI resubmitted to CTEP.
12/15/2025: LOI received CTEP Approval On Hold. Full Approval will be issued once the Drug Commitment Letter is received from Janssen.
01/06/2026: The first draft of the protocol is being written. RaPID is scheduled for 03/25/26.
01/07/2026: Janssen submitted signed Drug Commitment Letter to PIO/CTEP
01/13/2026: LOI Received CTEP Full Approval
02/03/2026 - Study team is working on the protocol. Stats PRC is scheduled for 04/15/26.
09/01/2026: Target Activation
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I. CAPSULE SUMMARY:
It is the responsibility of the Study Coordinator to make sure that all capsule summary form requirements are completed prior to submission of the summary for executive review. (See Capsule Summary Template for requirements)
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| Approval Date |
2025-02-25 |
| Comments |
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II. PROTOCOL DEVELOPMENT:
All of these steps must be completed before a protocol can be activated.
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a. Letter of Intent:
Phase II w/NCI-supplied drug OR go to II.c
Applicable: Yes
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| Primary Committee's Review |
Submission |
Approval
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| Comments |
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b. Concept Submission Form:
Phase III only
Applicable: Yes
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| Review |
Submission |
Approval |
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| Comments |
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c. Initial Protocol Draft/Review:
This process may be repeated until the final protocol is drafted.
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| Protocol Review |
Date/N/A |
| Study Coordinators/Committee Chair(s) |
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| Statistical Center |
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| Other Committee SCs (if needed) |
v |
| Drug Company (if needed) |
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| Other Reviews |
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| Draft Forms Inserted |
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| Ops Consistency Check |
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| NCI Protocol Submission Worksheet |
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| PRC Review |
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Intergroup CTSU:
QARC:
RPC:
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| Comments |
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| d. Final Protocol Draft/Review: |
| Protocol Review |
Date/N/A |
| Study Coordinators/Committee Chair(s) |
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| Statistical Center |
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| Others |
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CTEP/DCP
(copy for IND and contracts, if needed) |
| Submission: |
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| Consensus Review Received: |
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| Consensus Review Response: |
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| Approval on hold (if applicable): |
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| Final Approval: |
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CIRB
(if needed) |
| Submission: |
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| CIRB Review Received: |
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| CIRB Response Submitted: |
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| Approval: |
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| Final Ops Consistency Check |
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| Final PRC Review (if needed) |
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| Activation Amend (CTEP) |
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| Final Forms Inserted |
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| FFS Inserted |
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| Activation Memo/HIPAA |
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| Web Documents Prepared |
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| Database Flags Set |
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| Comments |
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III. ADMINISTRATIVE:
(if needed) Contract and IND will be completed by Dir. of Ops and Pharm. Liaison.
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| Budget for Drug Distribution |
| Applicable? |
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Date finalized |
| Yes |
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| Budget for Additional Support |
| Applicable? |
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Date finalized |
| Yes |
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| Budget for Correlative Studies |
| Applicable? |
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Date finalized |
| Yes |
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| Contract Signed |
| Applicable? |
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Date finalized |
| Yes |
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| IND Assigned |
| Applicable? |
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Date finalized |
| Yes |
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| Other Last Minute Issues? |
Membership:
Intergroup:
Financial:
Correlates:
Drug Issues:
Other:
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| Comments |
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IV. ACTIVATION:
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